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    Brain

    IDStudy TitleStatus
    CE10 (EORTC-2427-BTG)

    VIGOR: Vorasidenib as Maintenance Treatment after First-line Chemoradiotherapy in IDH-mutant Grade 2 or 3 Astrocytoma: A Placebo- controlled Randomized Phase III Study


    VIGOR: Vorasidenib as Maintenance Treatment after First-line Chemoradiotherapy in IDH-mutant Grade 2 or 3 Astrocytoma: A Placebo- controlled Randomized Phase III Study

    Complexity Level: 2

    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Planned



    		Planned
    CE7 (CE.7)

    A Phase III Trial of Stereotactic Radiosurgery Compared with Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) Plus Memantine for 5 or More Brain Metastases

    The purpose of this research study is to compare the effects (good or bad) of receiving stereotactic radiosurgery (SRS) versus receiving whole brain radiation therapy (WBRT) plus a drug called memantine, on brain metastases. Receiving SRS could control cancer that has spread to the brain.

    A Phase III Trial of Stereotactic Radiosurgery Compared with Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) Plus Memantine for 5 or More Brain Metastases

    Complexity Level: 2

    Eligibility: - Patient must have 5 or more brain metastases by MRI obtained within 30 days of enrollment. Largest brain metastasis must be <2.5cm, and total tumour volume must be 30cm3 or less - Patient must be willing and able to complete QoL questionnaires, neurocognitive assessments, and must agree to use effective contraception if of child bearing potential - Centre must be IROC credentialied and able to treat patients using an SRS system or HA-WBRT - Patient must have a pathological diagnosis of a non-hematopoietic malignancy - Patient must be >18 years old, ECOG 0-2, and creatinine clearance of 30ml/min or more

    Objectives: Primary Endpoints: - Overall Survival and neurocognitive PFS Secondary Endpoints: - time to CNS failure; difference in CNS failure patterns;number of salvage procedures following SRS; cognitive tests; adverse events; time delay to re-initiation of systemic therapy post treatment; validate nomogram; Health Economics; Quality of Life; Correlative Studies; Imaging data collection and evaluation

    NCT Registration ID (from clinicaltrials.gov): NCT03550391
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Open to Accrual
    Activation Date: May 25, 2018



    		Open to Accrual
    CE9 (LUMOS2)

    Low and Anaplastic Grade Glioma Umbrella Study of Molecular Guided Therapies (LUMOS2)

    Cancers of the brain are very serious, difficult to treat, and frequently lead to death. Patients with a specific type of brain cancer called grade 2 or grade 3 glioma may live for some time following initial treatment, but when the cancer comes back, it can behave similarly to the most aggressive brain tumours and not respond to the limited treatments that are available. We propose to study this group of patients in a clinical trial using new treatments. We will perform molecular analysis to identify the underlying problem of the cells in the tumour and provide treatment for that specific molecular abnormality. Patients without a molecular change identified will receive new but less specific treatment. We will follow these patients to see if the new treatments are effective. Specifically, we will look to see how many patients have their tumours increase in size or spread within the first six months, how long patients live, how often the disease responds to treatment, what is the quality of life for the patient, what is the safety and tolerability of the treatment, and whether we can determine the specific reason the treatment did or did not work using additional molecular analysis. If these new treatments are found to be possibly effective, we plan to develop future clinical trials to confirm they work in a larger study.

    Low and Anaplastic Grade Glioma Umbrella Study of Molecular Guided Therapies (LUMOS2)

    Complexity Level: 2

    Eligibility: Adults, aged 18 years and older Histologically confimed glioma IDH-mutant, histologically grade 2 or 3 at initial diagnosis (i.e., without necrosis or microvascular proliferation); including CDKN2A/B homozygous deleted IDH-mutant astrocytomas but not IDH-wildtype diffuse astrocytomas with any of TERT promoter mutation, EGFR amplification and/or +7/-10 copy number changes (i.e., molecular features of glioblastoma). Has evidence of progressive disease (defined as new contrast-enhancing tumour and/or 25% increase in the size of the T2/FLAIR area compared to prior imaging after prior treatment with radiotherapy and chemotherapy; with a clinical indication for neurosurgery). One prior treatment with radiotherapy and alkylating chemotherapy, defined as either sequential therapy with CNS radiotherapy then an alkylating agent, or concurrent CNS radiotherapy with an alkylating agent. ECOG performance status 0-2. Willing and able to comply with all study requirements, including treatment, timing

    Objectives: The primary objective of the study is to determine progression-free survival at six months (PFS6) The seondary objectives are to evaluate overall survival, response rate and health-related quality of life The tertiary objectives are to explore biomarkers associated with treatment sensitivity and resistance and conduct translational research to better understand the biology of recurrent G2/3, IDH-mutant glioma as well as Health economic analysis relating to the use of targeted or novel treatments in recurrent G2/3, IDH-mutant glioma.

    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Open to Accrual
    Activation Date: June 19, 2024



    		Open to Accrual
    CEC2 (NCCTG N0577)

    Phase III Intergroup Study of Radiotherapy versus Temozolomide Alone versus Radiotherapy with Concomitant and Adjuvant Temozolomide for Patients with 1p/19q Codeleted Anaplastic Glioma


    Phase III Intergroup Study of Radiotherapy versus Temozolomide Alone versus Radiotherapy with Concomitant and Adjuvant Temozolomide for Patients with 1p/19q Codeleted Anaplastic Glioma

    Complexity Level: 2

    Eligibility: Pre-registration . Inclusion Criteria - Willing to submit tissue samples for mandatory central pathology review submission and deletion status determination. It should be initiated as soon after surgery as possible. Inclusion Criteria >18 years of age; Newly diagnosed and .3 months from surgical diagnosis; Histological confirmation of anaplastic glioma (oligodendroglioma, mixed, or astrocytoma [WHO grade III]), as determined by pre-registration central pathology review, and tumor is also co-deleted for 1p and 19q. NOTE: Mixed gliomas are eligible, regardless of the degree of astrocytic or oligodendrocytic predominance, as long as the tumor is also co-deleted for 1p and 19q; 3.24 Surgery .2 weeks prior to registration must have recovered from the effects of surgery; The following laboratory values obtained 21 days prior to registration. . ANC .1500; . PLT .100,000; . Hgb>9; Total bilirubin .1.5 x UNL; SGOT (AST) .3 x UNL; Creatinine .1.5 x ULN

    Objectives: Survival; Progression Free Survival; Quality of Life; Cognitive Function; Correlative Biology.

    NCT Registration ID (from clinicaltrials.gov): NCT00887146
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: July 28, 2010 Closing Date: January 14, 2015



    		Closed to Accrual
    CEC7 (ALLIANCE A071801)

    Phase III Trial of Post-Surgical Single Fraction Stereotactic Radiosurgery (SRS) Compared with Fractionated SRS (FSRS) for Resected Metastatic Brain Disease


    Phase III Trial of Post-Surgical Single Fraction Stereotactic Radiosurgery (SRS) Compared with Fractionated SRS (FSRS) for Resected Metastatic Brain Disease

    Complexity Level: 2

    Eligibility: This study will recruit patients 18 years or older with Karnofsky PS => 60 who have one non-CNS primary brain metastasis completely resected <= 30 days prior to registration measuring 2 cm or larger with resection cavity < 5.0 cm. At the time of screening, patients must have 3 or fewer unresected brain metastases (<4.0 cm). Patients must be able to complete an MRI of the head with contrast, have no evidence of leptomeningeal metastasis, may not have a primary germ cell tumor, small cell carcinoma, or lymphoma, and no prior whole brain radiation therapy. Past radiosurgery to other lesions is allowed, with exceptions. Brain metastasis must be located => 5 mm of the optic chiasm and outside the brainstem. No resection of more than one brain metastasis.

    Objectives: The primary objective is to ascertain if time to surgical bed failure is increased with FSRS compared to SSRS in patients with resected brain metastasis. Secondary objectives include: emotional well-being at 9 months, overall survival, overall quality of life (QOL), functional independence, descriptively compare the post-treatment adverse events associated with the interventions, rates of radiation necrosis at 12 months, CNS failure patterns (local, distant brain failure, local leptomeningeal disease, widespread leptomeningeal disease), time to WBRT, emotional well-being and overall QOL in long-term survivors, time to surgical bed failure, and cognitive progression between FSRS and SSRS groups.

    NCT Registration ID (from clinicaltrials.gov): NCT04114981
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: May 22, 2020 Closing Date: October 14, 2022



    		Closed to Accrual
    CEC6 (ALLIANCE N0577)

    Phase III Intergroup Study of Radiotherapy with Concomitant and Adjuvant Temozolomide versus Radiotherapy with Adjuvant PCV Chemotherapy in Patients with 1p/19q Co-deleted Anaplastic Glioma or Low Grade Glioma


    Phase III Intergroup Study of Radiotherapy with Concomitant and Adjuvant Temozolomide versus Radiotherapy with Adjuvant PCV Chemotherapy in Patients with 1p/19q Co-deleted Anaplastic Glioma or Low Grade Glioma

    Complexity Level: 2

    Eligibility: Pre-registration - Inclusion Criteria Willing to submit tissue samples for mandatory central pathology review submission and deletion status determination. Registration Inclusion Criteria >18 years of age; Newly diagnosed and <3 months from surgical diagnosis; Histological confirmation of anaplastic glioma (oligodendroglioma, mixed, or astrocytoma [WHO grade 2 or 3]) or low grade glioma (WHO grade 2), as determined by pre-registration central pathology review, and tumor is co-deleted for 1p and 19q. NOTE: Mixed gliomas are eligible. Patients with codeleted low grade gliomas must also be considered "high risk." Tumor tissue must show co-deletion of chromosomes 1p and 19q by FISH analysis. Surgery must be performed >2 weeks prior to registration. Patient must have recovered from the effects of surgery; The following laboratory values obtained <21 days prior to registration: ANC>1500/mm^3; PLT>100,000/mm^3; Hgb>9 g/dL; Total bilirubin<1.5 x UNL; SGOT (AST)<3 x UNL; Creatinine<1.5 x ULN

    Objectives: To determine whether patients who receive radiotherapy with concomitant temozolomide followed by adjuvant temozolomide have a marginally better progression free survival as compared with patients who receive radiotherapy followed by PCV.

    NCT Registration ID (from clinicaltrials.gov): NCT00887146
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: March 22, 2016 Closing Date: June 10, 2024



    		Closed to Accrual
    CEC1 (EORTC 26053_22054)

    Phase III Trial On Concurrent And Adjuvant Temozolomide Chemotherapy In Non-1p/19q Deleted Anaplastic Glioma. The CATNON Intergroup Trial.


    Phase III Trial On Concurrent And Adjuvant Temozolomide Chemotherapy In Non-1p/19q Deleted Anaplastic Glioma. The CATNON Intergroup Trial.

    Complexity Level: 2

    Eligibility: Histologically confirmed newly diagnosed anaplastic oligodendroglioma, anaplastic oligoastrocytoma or anaplastic astrocytoma by local diagnosis

    Objectives: To assess whether concurrent radiotherapy with daily temozolomide chemotherapy improves overall survival as compared to no daily temozolomide in patients with non-1p/19q deleted anaplastic glioma. To assess whether adjuvant temozolomide chemotherapy improves survival as compared to no adjuvant temozolomide chemotherapy in patients with non-1p/19q deleted anaplastic glioma.

    NCT Registration ID (from clinicaltrials.gov): NCT00626990
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: July 22, 2009 Closing Date: September 15, 2015



    		Closed to Accrual
    CE8 (EORTC-1709-BTG)

    A Phase III Trial of Marizomib in Combination with Standard Temozolomide-Based Radiochemotherapy versus Standard Temozolomide-Based Radiochemotherapy Alone in Patients with Newly-Diagnosed Glioblastoma


    A Phase III Trial of Marizomib in Combination with Standard Temozolomide-Based Radiochemotherapy versus Standard Temozolomide-Based Radiochemotherapy Alone in Patients with Newly-Diagnosed Glioblastoma

    Complexity Level: 2

    Eligibility: WHO grade IV glioblastoma - Tumor resection or biopsy only - Availability of FFPR tumour block or slide for mandatory MGMT analysis - eligible for standard TMZ/RT ->TMZ - KPS>=70 - Recovered from effects of surgery - 18 years of age when ICF signed - stable or decreasing dose of steroids for 1 week prior - life expectancy of 3 months - Adequate organ function as per lab values - negative serum pregnancy test 7 days prior to first dose - no IDH1 mutation - no prior treatment for GBM other than surgery - planned treatment with TTF

    Objectives: To compare the overall survival of glioblastoma patients treated with standard TMZ-based radiochemotherapy alone or TMZ-based radiochemotherapy in combination with marizomib. Additionally, PFS survival will be compared in the two treatment arms. Additionally the safety and tolerability of TMZ-based radiochemotherapy in combination with marizomib will be assessed. The neurocognitive function and OoL of the MRZ arm will also be assessed.

    NCT Registration ID (from clinicaltrials.gov): NCT03345095
    Participation: Limited to invited centres; Site Selection Open
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: May 24, 2018 Closing Date: September 17, 2020



    		Permanently Closed
    CE5 (EORTC 22033-26033)

    Primary Chemotherapy with Temozolomide vs. Radiotherapy in Patients With Low Grade Gliomas After Stratification for Genetic 1p Loss: A Phase III Study.


    Primary Chemotherapy with Temozolomide vs. Radiotherapy in Patients With Low Grade Gliomas After Stratification for Genetic 1p Loss: A Phase III Study.

    Complexity Level: 2

    Eligibility: At registration: -Histologically proven low grade diffuse glioma (Astrocytoma WHO grade II , gemistocytic, fibrillary and protoplasmatic), Oligoastrocytoma WHO grade II and oligodendroglioma WHO II); supratentorial location only -WHO performance status <2; Age > 18 years; Informed consent; At randomization : Same as above +; Requiring treatment as demonstrated by at least one of the following criteria (1-4): 1. Age >40 years; 2. Radiologically proven progressive lesion; 3. Neurological symptoms others than seizures only (focal deficits, signs of raised intracranial pressure, mental deficits); 4. Intractable seizures; Not candidate for treatment exclusively by surgery; RTOG neurological function 0-3; Results of genetic testing (1p) available; Adequate hematological, renal and hepatic function; No previous radiotherapy to the brain, no prior chemotherapy, patient EORTC 22033-26033 RTX vs. TMZ in LGG stratifying for 1p loss; has recovered from any surgery; No second primary exc BCC skin

    Objectives: Primary: PFS Secondary: Overall survival, Quality of life and Minimental State Examination (MMSE), Adverse events, neurocognitive function (for dedicated centers)

    NCT Registration ID (from clinicaltrials.gov): NCT00182819
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: January 06, 2006 Closing Date: March 28, 2013



    		Permanently Closed
    CE3 (26981-22981)

    A Randomized Phase III Study of Concomitant and Adjuvant Temozolomide and Radiotherapy For Newly Diagnosed Glioblastoma Multiforme


    A Randomized Phase III Study of Concomitant and Adjuvant Temozolomide and Radiotherapy For Newly Diagnosed Glioblastoma Multiforme

    Eligibility: Patients with histologically confirmed newly diagnosed glioblastoma multiforme who have not received prior chemotherapy or radiotherapy; 18 to 70 years of age; WHO performance status < 2; stable, non-increasing dose of corticosteroids; adequate blood counts, liver and kidney function.

    Objectives: The primary objective of the trial is to test the efficacy of administration of temozolomide as a concomitant and adjuvant treatment to radiotherapy with respect to overall survival compared to radiotherapy alone. The secondary objectives are to compare the two treatment arms with respect to toxicity profile, progression free survival and quality of life.

    NCT Registration ID (from clinicaltrials.gov): NCT00006353
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: May 29, 2000 Closing Date: March 22, 2002



    		Permanently Closed
    CEC3 (NCCTG N107C)

    A Phase III Trial of Post-Surgical Stereotactic Radiosurgery (SRS) Compared with Whole Brain Radiotherapy (WBRT) for Resected Metastatic Brain Disease


    A Phase III Trial of Post-Surgical Stereotactic Radiosurgery (SRS) Compared with Whole Brain Radiotherapy (WBRT) for Resected Metastatic Brain Disease

    Complexity Level: 1

    Eligibility: Four or fewer brain metastases (as defined on the pre-operative MRI brain scan) and status post resection of one of the lesions. Pathology from the resected brain metastasis must be consistent with a non-central nervous system primary site.

    Objectives: Primary: Overall Survival, Cognitive Function Secondary: Local Control Of The Surgical Bed; Time To CNS Failure; Various Quality Of Life; A Biologic Correlate

    NCT Registration ID (from clinicaltrials.gov): NCT01372774
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: September 29, 2011 Closing Date: December 18, 2015



    		Permanently Closed
    CE6 (CE6)

    A Randomized Phase III Study of Temozolomide and Short-Course Radiation vs. Short-Course Radiation Alone in the Treatment of Newly Diagnosed Glioblastoma Multiforme in Elderly Patients.


    A Randomized Phase III Study of Temozolomide and Short-Course Radiation vs. Short-Course Radiation Alone in the Treatment of Newly Diagnosed Glioblastoma Multiforme in Elderly Patients.

    Complexity Level: 2

    Eligibility: Patients 65 years of age or older, with newly diagnosed, histopathologically confirmed, glioblastoma multiforme (GBM, WHO grade IV), who have had prior surgery/biopsy at diagnosis and who are not deemed suitable by their treating physician to receive the standard radiotherapy regimen (60Gy/30 fractions over 6 weeks) in combination with temozolomide.

    Objectives: PRIMARY: To compare the overall survival (OS) rates between short-course radiation therapy alone and short-course radiation therapy given together with concurrent and adjuvant temozolomide, in elderly (65 years of age or older) patients with newly diagnosed glioblastoma multiforme (GBM, WHO grade IV), who have had prior surgery/biopsy at diagnosis and who are not deemed suitable by their treating physician to receive the standard radiotherapy regimen (60Gy/30 fractions over 6 weeks) in combination with temozolomide. SECONDARY: To compare progression-free survival (PFS) between the two arms; To compare the nature, severity, and frequency of adverse events between the two arms; To compare the quality of life between the two arms using the EORTC QLQ-C30 and the EORTC Brain Cancer Module (QLQ-BN20); To conduct molecular correlative studies (mandatory: MGMT promoter status; optional: tissue banking).

    NCT Registration ID (from clinicaltrials.gov): NCT00482677
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: May 01, 2007 Closing Date: October 01, 2013



    		Permanently Closed
    CE4 (26021)

    Observation Versus Conventional-Fractionated Radiotherapy or Radiosurgery After Non-Radical Surgery for Benign Intracranial Meningiomas: a Phase III Study.


    Observation Versus Conventional-Fractionated Radiotherapy or Radiosurgery After Non-Radical Surgery for Benign Intracranial Meningiomas: a Phase III Study.

    NCT Registration ID (from clinicaltrials.gov): NCT00104936
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: September 29, 2005 Closing Date: October 23, 2006



    		Permanently Closed
    CEC5 (ALLIANCE A221208)

    Phase II Study of Corticosteroid + Bevacizumab vs Corticosteroid + Placebo (BeST) for Radionecrosis after Radiosurgery for Brain Metastases


    Phase II Study of Corticosteroid + Bevacizumab vs Corticosteroid + Placebo (BeST) for Radionecrosis after Radiosurgery for Brain Metastases

    Complexity Level: 2

    Eligibility: Patients enrolled in this study must have a diagnosis of radionecrosis based on a clinical onset of symptoms and radiological findings of radionecrosis at 3 - 24 months following radiosurgery for brain metastases, with or without pathological confirmation. For this trial, the primary solid tumour indicating brain metastases includes, but is not limited to: lung, breast, colorectal cancer, but excluding melanoma, choriocarcinoma, renal cell carcinoma or gliomas (due to high risk of intratumoural hemorrhage). Prior to the start of treatment patient must have been taking a stable dose of corticosteroids for symptom management for at least 1 week before baseline MRI. Patients will have a Karnofsky Performance Status > 60%. It is required that patients do not have any systemic therapy within 2 weeks prior to registration or plan for systemic therapy within the first 8 weeks after study registration (with exceptions) nor any bevacizumab within 3 months of study registration.

    Objectives: Primary Objective:To investigate whether the addition of bevacizumab to standard corticosteroid therapy results in greater improvement in symptoms (clinical and patient-reported symptom improvement associated with radionecrosis and less radionecrosis treatment-induced symptoms) compared with standard corticosteroid therapy. Secondary Objectives:To evaluate the toxicity profile associated with bevacizumab and corticosteroid therapy.To compare self-reported health related quality of life (HRQOL) using LASA, Dexamethasone Symptoms Questionnaire-Chronic (DSQ-C), and MDASI-BT symptom and interference score between treatment arms.To compare intracranial progression-free survival and time to maximum radiographic response between treatment arms.To compare the dose and duration of corticosteroid required between treatment arms and correlate steroid requirement with DSQ-C and MDASI-BT scores.Correlative Objectives:To explore serum/urine/imaging biomarkers that predict for treatment response.

    NCT Registration ID (from clinicaltrials.gov): NCT02490878
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: December 23, 2016 Closing Date: October 12, 2018



    		Permanently Closed
    CE1

    NCIC Cooperative Clinical Trial on Treatment of Cerebral Tumours (Glioblastomas) With Pre-Operative BCNU and Superfractionated Radiotherapy


    NCIC Cooperative Clinical Trial on Treatment of Cerebral Tumours (Glioblastomas) With Pre-Operative BCNU and Superfractionated Radiotherapy

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: May 05, 1980 Closing Date: December 15, 1981



    		Permanently Closed
    CE2 (RTOG 94-02)

    Phase III Intergroup Randomized Comparison of Radiation Alone versus Pre-radiation Chemotherapy For Pure and Mixed Anaplastic Oligodendrogliomas.


    Phase III Intergroup Randomized Comparison of Radiation Alone versus Pre-radiation Chemotherapy For Pure and Mixed Anaplastic Oligodendrogliomas.

    Complexity Level: 2

    Eligibility: Patients with histologically confirmed supratentorial pure or mixed anaplastic oligodendrogliomas who have not received prior radiotherapy or chemotherapy and do not have chronic lung disease; a Karnofsky performance status of > 60 and adequate blood counts, liver and kidney function required.

    Objectives: To compare overall survival and time to tumour progression in patients treated with intensive-PVC (procarbazine, CCNU [lomustine] and vincristine)followed by radiation to those patients treated with radiation alone. Also to compare the frequencies of severe toxicities, quality of life and neurologic function between the two arms.

    NCT Registration ID (from clinicaltrials.gov): NCT00002569
    Participation: Limited to centres 1) which are not currently RTOG members; 2) with current CPA #
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: October 23, 1996 Closing Date: March 29, 2002



    		Permanently Closed
    CE5S (NCIC CTG)

    Socio-behavioral Study Work, Marriage/Social Support, Anxiety and Depression NCIC CTG CE5S


    Socio-behavioral Study Work, Marriage/Social Support, Anxiety and Depression NCIC CTG CE5S

    Complexity Level: 3

    Eligibility: Histologically proven low-grade glioma. Astrocytoma WHO grade II, Obligoastrocytoma WHO grade II, Oligodendroglioma WHO grade II, Supratentorial tumor location only, WHO performance status < or =2, Age > or =18, no previous chemo/rad for brain tumour.

    Objectives: The goal of this supplemental evaluation is to add a socio-behavorial component to the CE5 protocol in order to provide a more detailed description of important social (marital status), emotional (depression, anxiety) and occupational (work status) consequences of low grade glioma and its treatments.

    NCT Registration ID (from clinicaltrials.gov): no NCT
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 22, 2007 Closing Date: April 11, 2013



    		Permanently Closed

    Breast

    IDStudy TitleStatus
    MAC27 (ALLIANCE A011801)

    COMPASSHER2 Residual Disease (RD), A Double-Blinded, Phase III Randomized Trial of T-DM1 and Placebo Compared with T-DM1 and Tucatinib

    The purpose of this study is to determine how well trastuzumab emtansine (T-DM1) and tucatinib work in preventing breast cancer from coming back (relapsing) in patients with high risk, HER2 positive breast cancer. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called DM1. Trastuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors, and delivers DM1 to kill them. Tucatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving T-DM1 and tucatinib may work better in preventing breast cancer from relapsing in patients with HER2 positive breast cancer compared to T-DM1 alone.

    COMPASSHER2 Residual Disease (RD), A Double-Blinded, Phase III Randomized Trial of T-DM1 and Placebo Compared with T-DM1 and Tucatinib

    Complexity Level: 2

    Eligibility: Confirmed HER2-positive breast cancer, who received neoadjuvant chemotherapy, have had total mastectomy with no gross residual disease at the margin of resection, or breast-conserving surgery with histologically negative margins of excision. Must have axilla evaluated with either sentinel node biopsy or axillary lymph node dissection. Patients must have adequate hepatic, renal, and bone marrow function. Patients must not be pregnant and not nursing, must be 18 years or older (male or female), and ECOG Performance Status of 1 or less.

    Objectives: The primary objective is to determine if the iDFS with T-DM1 and tucatinib is superior to the iDFS in the control arm (T-DM1 + placebo) when administered to high-risk patients with HER2-positive breast cancer and residual disease after neoadjuvant HER2-directed therapy. Secondary objectives: (1) To evaluate whether treatment with tucatinib plus T-DM1 compared to treatment with T-DM1 alone (T-DM1 plus placebo) improves the following: overall survival (OS), breast cancer free survival (BCFS), distant recurrence-free survival (DRFS), disease-free survival (DFS), brain metastases-free survival (BMFS). (2) To evaluate whether treatment with tucatinib plus T-DM1 compared to treatment with T-DM1 alone (T-DM1 plus placebo) reduces the incidence of brain metastases.

    NCT Registration ID (from clinicaltrials.gov): NCT04457596
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Open to Accrual
    Activation Date: March 03, 2022



    		Open to Accrual
    MAC22 (ECOG-ACRIN EA1151)

    Tomosynthesis Mammographic Imaging Screening Trial (TMIST)

    This randomized phase III trial studies digital tomosynthesis mammography and digital mammography in screening patients for breast cancer. Screening for breast cancer with tomosynthesis mammography may be superior to digital mammography for breast cancer screening and may help reduce the need for additional imaging or treatment.

    Tomosynthesis Mammographic Imaging Screening Trial (TMIST)

    Complexity Level: 3

    Eligibility: Patients must be women between the age 45 and 75 at the time of study entry. Women of childbearing potential must not be known to be pregnant or lactating Patients must be scheduled for, or have intent to schedule, a screening mammogram Patients must be able to tolerate digital breast tomosynthesis and full-field digital mammographic imaging required by protocol. Written informed consent No symptoms or signs of benign or malignant breast disease No screening mammogram within the last 11 months prior to date of randomization No previous personal history of breast cancer including ductal carcinoma in situ No breast enhancements

    Objectives: To compare the proportions of participants in the Tomosynthesis (TM) and Digital Mammography (DM) study arms experiencing the occurrence of an advanced breast cancer at any time during a period of 4.5 years from randomization, including the period of active screening and a period of clinical follow-up after the last screen

    NCT Registration ID (from clinicaltrials.gov): NCT03233191
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Open to Accrual
    Activation Date: October 13, 2017



    		Open to Accrual
    MA39 (MA.39)

    Tailor RT: A Randomized Trial of Regional Radiotherapy in Biomarker Low Risk Node Positive and T3N0 Breast Cancer

    Women with node positive breast cancer normally will receive endocrine therapy and some may receive chemotherapy to help prevent the cancer from coming back. Many women will also receive radiotherapy to the whole breast/chest area and the surrounding lymph glands (called regional radiotherapy). No one really knows whether patients with low risk breast cancer need to receive regional radiotherapy. Some women may be getting regional radiotherapy who do not need it. These women may be exposed to the side effects of their treatment without benefit. The purpose of this study is to compare the effects on women with low risk breast cancer of receiving usual care that includes regional radiation therapy, with receiving no regional radiation therapy. Researchers want to see if not giving this type of radiation treatment works as well at preventing breast cancer from coming back.

    Tailor RT: A Randomized Trial of Regional Radiotherapy in Biomarker Low Risk Node Positive and T3N0 Breast Cancer

    Complexity Level: 2

    Eligibility: 1) Newly diagnosed histologically proven invasive carcinoma of the breast with no evidence of metastases. 2) Must have been treated by BCS or mastectomy with clear margins of excision. 3) Patients with T3N0 disease are eligible. 4) Patients with disease limited to nodal micrometastases are eligible. 5) If treated by an axillary dissection must have 1-3 positive axillary nodes. 6) If treated by a SLNB alone must have only 1-2 positive axillary nodes. 7) Must be ER greater than or equal to 1% and Her2 negative on local testing. 8) Must have an Oncotype DX recurence score of 25 or less. 9) Must consent to provision of tissue and blood for mandatory correlative studies 10) Must have had endocrine therapy initiated or planned for greater than or equal to 5 years 11) ECOG performance status must be 0,1 or 2. 12) Age must be greater than or equal to 35 years.

    Objectives: Primary: To compare the breast cancer recurrence-free interval (BCRFI) between patients that received regional RT or not, defined as time from randomization to time of invasive recurrent disease in the ipsilateral chestwall, breast, regional nodes, distant sites or death due to BC. Secondary: 1) Invasive disease-free survival (DFS); 2) Breast cancer mortality; 3) Overall survival (OS); 4) Locoregional recurrence-free interval (LRRFI); 5) Distant recurrence-free interval (DRFI); 6) Toxicity; 7) Arm volume and mobility 8) Patient reported outcomes (PROs) and Quality of Life (QOL); 9) Cost effectiveness Tertiary: 1) To establish a comprehensive tumour bank; 2) To evaluate the ability of intrinsic subtype to predict study outcomes and the effect of regional RT on these outcomes; 3) To evaluate other radiation signatures to prognosticate and predict effect of regional RT; 4) To describe the prevalence of ctDNA and evaluate its prognostic ability

    NCT Registration ID (from clinicaltrials.gov): NCT03488693
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: CCTG Led Trial
    Status: Open to Accrual
    Activation Date: May 30, 2018



    		Open to Accrual
    MAC30 (NRG BR009)

    A Phase III Adjuvant Trial Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression plus Endocrine Therapy in Premenopausal Patients with pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score </= 25 (OFSET)

    Testing the addition of chemotherapy to the usual treatment of ovarian function suppression plus hormonal therapy in premenopausal ER-positive/HER2-negative breast cancer patients who are at high risk of cancer returning

    A Phase III Adjuvant Trial Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression plus Endocrine Therapy in Premenopausal Patients with pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score

    Complexity Level: 2

    Eligibility: Female patients must be ≥ 18 years of age and premenopausal. May have ipsilateral or contralateral synchronous breast cancer if the highest stage tumor meets entry criteria. May have multicentric or multifocal breast cancer if the highest stage tumor meets entry criteria, and the other sites of disease would not require chemotherapy or HER2-directed therapy. Must have undergone axillary staging with sentinel node biopsy (SNB), targeted axillary dissection (TAD), or axillary lymph node dissection (ALND). Primary tumor must be pT1-3. (If N0, must be T1c or higher.). Ipsilateral nodes must be pN0 or pN1 (pN1mi, pN1a, pN1b, pN1c). Must be ER/PR postiive and HER2 negative.

    Objectives: To determine whether adjuvant chemotherapy (ACT) added to ovarian function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in improving invasive breast cancer-free survival (IBCFS) among premenopausal, early- stage breast cancer (EBC) patients with estrogen receptor (ER)-positive, HER2-negative tumors and 21-gene recurrence score (RS) between 16-25 (for pN0 patients) and 0-25 (for pN1 patients).

    NCT Registration ID (from clinicaltrials.gov): NCT05879926
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Open to Accrual
    Activation Date: August 28, 2024



    		Open to Accrual
    MAC29 (ALLIANCE A012103)

    OptimICE-pCR: De-escalation of Therapy in Early-Stage TNBC Patients who Achieve pCR after Neoadjuvant Chemotherapy with Checkpoint Inhibitor Therapy

    Pembrolizumab vs. observation in people with triple-negative breast cancer who had a pathologic complete response after chemotherapy plus pembrolizumab

    OptimICE-pCR: De-escalation of Therapy in Early-Stage TNBC Patients who Achieve pCR after Neoadjuvant Chemotherapy with Checkpoint Inhibitor Therapy

    Complexity Level: 2

    Eligibility: Patients with a history of stage T1cN1-2 or T2-4N0-2 breast cancer according to the primary tumor-regional lymph node anatomic staging criteria of the American Joint Committee on Cancer (AJCC), 8th edition as determined by the investigator in radiologic assessment, clinical assessment or both. Patients must have no residual invasive disease in the breast or lymph nodes after the completion of neoadjuvant therapy. Residual DCIS is allowed. Isolated tumor cells are considered node-negative. ER and PR ≤10%; HER2-negative.

    Objectives: To evaluate whether observation results in a non-inferior RFS compared to adjuvant pembrolizumab in early-stage TNBC patients who achieve a pCR after neoadjuvant chemotherapy with pembrolizumab. RFS by stage at presentation and by receipt of prior anthracycline therapy, AE event rate, OS, LRR and QOL by age, race, and ethnicity, AEs related to RTX.

    NCT Registration ID (from clinicaltrials.gov): NCT05812807
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Open to Accrual
    Activation Date: March 28, 2024



    		Open to Accrual
    MAC28 (NRG BR007)

    A Phase III Clinical Trial Evaluating De-escalation of Breast Radiation for Conservative Treatment of Stage 1, Hormone Sensitive, HER2-Negative, Oncotype Recurrence Score </=18 Breast Cancer (DEBRA)

    To evaluate the treatment of low-risk breast cancer with breast conservation surgery (BCS) and hormonal therapy compared to the usual treatment of BCS followed by hormonal therapy and regional radiation therapy.

    A Phase III Clinical Trial Evaluating De-escalation of Breast Radiation for Conservative Treatment of Stage 1, Hormone Sensitive, HER2-Negative, Oncotype Recurrence Score

    Complexity Level: 2

    Eligibility: Patients with resected pT1N0M0, HER2-Negative, ER and/or PgR-Positive Breast Cancer and Oncotype-DX Recurrence Score less than or equal to 18.

    Objectives: Primary objective: To evaluate whether breast conservation surgery and endocrine therapy results in a non-inferior rate of invasive or non-invasive ipsilateral breast tumor recurrence (IBTR) compared to breast conservation with breast radiation and endocrine therapy.

    NCT Registration ID (from clinicaltrials.gov): NCT04852887
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Open to Accrual
    Activation Date: December 23, 2021



    		Open to Accrual
    MAC18 (ALLIANCE A221405)

    POSITIVE: A Study Evaluating the Pregnancy Outcomes and Safety of Interrupting Endocrine Therapy for Young Women with Endocrine Responsive Breast Cancer who Desire Pregnancy


    POSITIVE: A Study Evaluating the Pregnancy Outcomes and Safety of Interrupting Endocrine Therapy for Young Women with Endocrine Responsive Breast Cancer who Desire Pregnancy

    Complexity Level: 3

    Eligibility: Premenopausal women with endocrine responsive early breast cancer who received adjuvant endocrine therapy for 18 to 30 months, are between 18 and 42 years of age at enrollment, and wish to interrupt endocrine therapy to attempt pregnancy.

    Objectives: Primary objective: To assess the risk of breast cancer relapse associated with temporary interruption of endocrine therapy (ET) to permit pregnancy. Secondary objective: To evaluate factors associated with pregnancy success after interruption of endocrine therapy.

    NCT Registration ID (from clinicaltrials.gov): NCT02308085
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: March 16, 2016 Closing Date: January 02, 2020



    		Closed to Accrual
    MAC19 (ALLIANCE A011202)

    A Randomized Phase III Trial Evalulating the Role of Axillary Lymph Node Dissection in Breast Cancer Patients (cT1 -3 N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy


    A Randomized Phase III Trial Evalulating the Role of Axillary Lymph Node Dissection in Breast Cancer Patients (cT1 -3 N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy

    Complexity Level: 2

    Eligibility: Please refer to the protocol for a complete list of eligibility criteria. Patients > 18 years of age. Clinical stage T1-3 N1 M0 breast cancer at Dx prior to start of neoadjuvant chemotherapy. No inflammatory breast cancer. No other malignancy within 5 years of registration with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the cervix. Axillary ultrasound with FNA or core needle biopsy of axillary lymph nodes at time of diagnosis documenting axillary metastasis prior to or within 14 days of starting neoadjuvant chemotherapy. ER, PgR and HER-2 status (by IHC and/or ISH) evaluated from diagnostic core bx prior to start of neoadjuvant chemotherapy Pt must have completed at least 4 cycles of neoadjuvant chemotherapy prior to surgery

    Objectives: Primary: To evaluate whether radiation to the undissected axilla and regional lymph nodes is not inferior to axillary lymph node dissection with radiation to the regional lymph nodes but not to the dissected axilla in terms of invasive breast cancer recurrence-free interval in patients with positive SLN(s) after completion of neoadjuvant chemotherapy.

    NCT Registration ID (from clinicaltrials.gov): NCT01901094
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: December 17, 2015 Closing Date: July 01, 2022



    		Closed to Accrual
    MAC20 (ALLIANCE A011401)

    Randomized Phase III Trial Evaluating the Role of Weight Loss In Adjuvant Treatment of Overweight and Obese Women with Early Breast Cancer


    Randomized Phase III Trial Evaluating the Role of Weight Loss In Adjuvant Treatment of Overweight and Obese Women with Early Breast Cancer

    Complexity Level: 3

    Eligibility: Adult women with histologic diagnosis of invasive HER2 negative breast cancer within the past 12 months, who have a BMI >=27 kg/m^2 at the time of enrollment, who have completed all adjuvant or neoadjuvant chemotherapy and surgery, who do not have diabetes or comorbid conditions that would cause life expectancy of <4 years, and who have a self-reported ability to walk at least 2 blocks (at any pace).

    Objectives: Primary Objective: Effect of supervised weight loss intervention plus health education materials vs. health education materials alone on invasive disease free survival in overweight and obese women. Secondary Objectives: Relationship between weight change and iDFS/clinical benefit; OS, distant DFS, weight/body composition, insulin resistance; Impact of supervised weight loss intervention on iDFS within subgroups of women (hormone receptor positive vs. negative breast cancer; premenopausal vs. menopausal); Quality of Life (QoL); physical activity and dietary intake; Patient reported outcomes (PRO).

    NCT Registration ID (from clinicaltrials.gov): NCT02750826
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: November 11, 2016 Closing Date: February 15, 2021



    		Closed to Accrual
    MAC23 (ALLIANCE A221505)

    RT CHARM:Phase III Randomized Trial of Hypofractionated Post-Mastectomy Radiation with Breast Reconstruction


    RT CHARM:Phase III Randomized Trial of Hypofractionated Post-Mastectomy Radiation with Breast Reconstruction

    Complexity Level: 2

    Eligibility: This study will recruit women and men >=18 post mastectomy due to invasive breast cancer with planned chest wall reconstruction and radiation. Patients will be approached based on the following main criteria: no prior radiation therapy to the chest, neck or axilla, no prior history of ipsilateral breast cancer, no history of prior or concurrent contralateral invasive breast cancer, negative inked histologic margins from mastectomy pathology and Zubrod performance status of 0-1

    Objectives: To evaluate whether the reconstruction complication rate at 24 months post radiation is non-inferior with hypofractionation. Secondary objectives include: acute and late radiation complications, based on CTCAE 4.0 toxicity, local and local regional recurrence rate, photographic cosmesis 24 months after radiation, lymphedema at 24 months after radiation, patient satisfaction and well-being at 24 months after radiation (BreastQ,)compare reconstruction complication rates based on reconstruction method and timing of reconstruction, cost and healthcare utilization based on hypofractionation and reconstruction technique

    NCT Registration ID (from clinicaltrials.gov): NCT03414970
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: March 27, 2018 Closing Date: August 11, 2021



    		Closed to Accrual
    MAC24 (SWOG S1418)

    A Randomized, Phase III Trial to Evaluate the Efficacy and Safety of Pembrolizumab (MK-3475) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer with >/= 1 cm Residual Invasive Cancer or Positive Lymph Nodes (ypN1mi, ypN1-3) After Neoadjuvant Chemotherapy


    A Randomized, Phase III Trial to Evaluate the Efficacy and Safety of Pembrolizumab (MK-3475) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer with >/= 1 cm Residual Invasive Cancer or Positive Lymph Nodes (ypN1mi, ypN1-3) After Neoadjuvant Chemotherapy

    Complexity Level: 2

    Eligibility: Histologicaly confirmed triple negative breast cancer, must not have metastatic or locally recurrent disease, must have available minimum of five unstained slides from the residual (post-neoadjuvant) invasive tumor in primary site or lymph node. Patients must have had neoadjuvant chemotherapy followed by surgery, completed their final breast surgery, must be 18 years or older, and Zubrod Performance Status of 2 or less

    Objectives: Primary objective is to compare invasive disease-free survival of patients with triple-negative breast cancer who have either >/=1 cm residual invasive breast cancer and/or positive lymph nodes (>ypN+) after neoadjuvant chemotherapy randomized to receive 1 year of MK-3475 adjuvant therapy compared to no MK-3475, in both the entire study population and also in the PD-L1 positive subset. Secondary objectives: 1. To compare the effects of MK-3475 on overall survival and distant recurrence-free survival between the two randomized arms for the PD-L1 positive patients and then all patients.2. To assess the toxicity and tolerability of MK-3475 in this patient population with or without radiation therapy. BAHO Study objectives: 1.examine the association between biomarkers of inflammation and quality of life and patient-reported outcomes between the two groups during and at the end of therapy and to examine the long-term and late effects of treatment on patient-reported outcomes.

    NCT Registration ID (from clinicaltrials.gov): NCT02954874
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: December 11, 2018 Closing Date: June 30, 2021



    		Closed to Accrual
    MAC25 (NRG-BR004)

    A Randomized, Double-Blind, Phase III Trial of Taxane/Trastuzumab/Pertuzumab with Atezolizumab or Placebo in First-Line HER2-Positive Metastatic Breast Cancer


    A Randomized, Double-Blind, Phase III Trial of Taxane/Trastuzumab/Pertuzumab with Atezolizumab or Placebo in First-Line HER2-Positive Metastatic Breast Cancer

    Complexity Level: 2

    Eligibility: This study will recruit women and men =>18 with ECOG performance status 0-1 with histologically confirmed adenocarcinoma of the breast with locally recurrent, unresectable disease or metastatic disease (HER 2-positive). Patients must have measurable disease based on RECIST 1.1. Adequate hematologic, hepatic and renal function within 14 days prior to randomization is required. Patients must not have cardiac disease history and history or risk of autoimmune disease.

    Objectives: The primary objective is to determine whether the addition of atezolizumab to a regimen of pertuzumab and trastuzumab combined with a taxane will improve the PFS, assessed by investigator using RECIST 1.1 criteria, relative to a regimen of a taxane, pertuzumab, trastuzumab, and placebo in patients with newly documented HER2-positive measurable metastatic breast cancer. Secondary objectives include determining whether the addition of atezolizumab to a regimen of paclitaxel, pertuzumab, and trastuzumab will: improve the overall survival relative to a regimen of paclitaxel, pertuzumab, trastuzumab, and placebo; improve the overall objective response, assessed by investigator using RECIST 1.1 criteria, relative to a regimen of paclitaxel, pertuzumab, trastuzumab, and placebo; improve PFS, OR, and/or duration of objective response assessed by retrospective blinded central review using RECIST 1.1 criteria, relative to a regimen of paclitaxel, pertuzumab, trastuzuma and placebo.

    NCT Registration ID (from clinicaltrials.gov): NCT03199885
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: January 08, 2020 Closing Date: May 20, 2022



    		Closed to Accrual
    MAC26 (SWOG S1706)

    A Phase II Randomized Trial of Olaparib (NSC-747856) Administered Concurrently with Radiotherapy versus Radiotherapy Alone for Inflammatory Breast Cancer


    A Phase II Randomized Trial of Olaparib (NSC-747856) Administered Concurrently with Radiotherapy versus Radiotherapy Alone for Inflammatory Breast Cancer

    Complexity Level: 2

    Eligibility: Patients must be =>18 with a Zubrod Performance Status =< 2. Patients must have adequate: hematologic, renal and hepatic function. Patients must not have: a history of other prior malignancy or uncontrolled infection; a history of resting ECG indicating uncontrolled potential reversible cardia conditions symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia; MDS/AML; major surgery within 2 weeks of starting study treatment; history of uncontrolled ventricular arrhythmia; previous allogenic bone marrow transplant; whole blood transfusions. Patients must be able to swallow and retain oral medication.

    Objectives: Primary objective is to compare the Invasive Disease-Free Survival (IDFS) of patients with inflammatory breast cancer receiving concurrent administration of olaparib with standard doses of radiotherapy to the chest wall and regional lymph nodes compared to standard doses of radiotherapy alone to the chest wall and regional lymph nodes. Secondary objective is to compare the effect of concurrent administration of olaparib with radiotherapy versus radiotherapy alone on improvement in locoregional control (measured by Locoregional Recurrence-Free Interval), Distant Relapse-Free Survival, and Overall Survival in inflammatory breast cancer patients.

    NCT Registration ID (from clinicaltrials.gov): NCT03598257
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: May 28, 2019 Closing Date: July 01, 2024



    		Closed to Accrual
    MA34 (BIG 4-11)

    A Randomized Multicenter, Double-Blind, Placebo-Controlled Comparison of Chemotherapy Plus Trastuzumab Plus Placebo versus Chemotherapy Plus Trastuzumab Plus Pertuzumab as AdjuvantTherapy in Patients with Operable HER2-Positive Primary Breast Cancer


    A Randomized Multicenter, Double-Blind, Placebo-Controlled Comparison of Chemotherapy Plus Trastuzumab Plus Placebo versus Chemotherapy Plus Trastuzumab Plus Pertuzumab as AdjuvantTherapy in Patients with Operable HER2-Positive Primary Breast Cancer

    Complexity Level: 2

    Eligibility: Early breast cancer; HER2 positive centrally confirmed;, PS 0 -1, adequate bone marrow, liver, renal function; LVEF > 50%,blocks available for central collection. T1-4 any with N1 or T1c N0 or T1b NO if another high risk factor such as ER negative, age < 36 or Grade 3. The T1bN0 population will be limited to < 10% of the total population of 3806.

    Objectives: Primary: Disease Free Survival Secondary: Overall Survival; EFS; QoL; A biologic correlate

    NCT Registration ID (from clinicaltrials.gov): NCT01358877
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: April 05, 2012 Closing Date: June 28, 2013



    		Closed to Accrual
    MAC12 (ECOG PACCT-1)

    Program for the Assessment of Clinical Cancer Tests (PACCT-1): Trial Assigning IndividuaLized Options for Treatment: The TAILORx Trial


    Program for the Assessment of Clinical Cancer Tests (PACCT-1): Trial Assigning IndividuaLized Options for Treatment: The TAILORx Trial

    Complexity Level: 2

    Eligibility: Patients with operable histologically confirmed adenocarcinoma of the female breast who have completed primary surgical treatment. ER and/or PR-positive Negative axillary nodes Tumor size 1.1-5.0cm (or 5mm-1.0cm) plus unfavorable histological features.

    Objectives: Primary: To determine whether adjuvant hormonal therapy is not inferior to adjuvant chemohormonal. To create a tissue and specimen bank for patients enrolled in this trial. Secondary: To determine whether adjuvant hormonal therapy is sufficient treatment for women whose tumors meet established clinical guidelines. The primary study endpoint is disease-free survival; other co-primary endpoints include distant recurrence free interval, recurrence free interval, and overall survival.

    NCT Registration ID (from clinicaltrials.gov): NCT00310180
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: September 21, 2006 Closing Date: October 06, 2010



    		Closed to Accrual
    MA36 (BIG 6-13)

    A Randomised, Double-Blind, Parallel group, Placebo-Controlled Multicenter Phase III Study to Assess the Efficacy and Safety of Olaparib versus Placebo as Adjuvant Treatment in Patients with Germline BRCA1/2 Mutations and High Risk HER2 Negative Primary Breast Cancer Who Have Completed Definitive Local Treatment and Neoadjuvant or Adjuvant Chemotherapy


    A Randomised, Double-Blind, Parallel group, Placebo-Controlled Multicenter Phase III Study to Assess the Efficacy and Safety of Olaparib versus Placebo as Adjuvant Treatment in Patients with Germline BRCA1/2 Mutations and High Risk HER2 Negative Primary Breast Cancer Who Have Completed Definitive Local Treatment and Neoadjuvant or Adjuvant Chemotherapy

    Complexity Level: 2

    Eligibility: For inclusion in the study patients should fulfil the following criteria: Provision of informed consent prior to any study specific procedures, female or male patients must be greater than or equal to 18 years of age, histologically confirmed non-metastatic primary triple negative invasive adenocarcinoma of the breast that is at surgery: either axillary node-positive (any size) or node negative with primary tumour >2cm for patients who received adjuvant chemotherapy or showing evidence of non pCR for patients who received neoadjuvant chemotherapy. Patients must have a documented mutation in BRCA1 or BRCA2 predicted or suspected deleterious. Submission of (FFPE) tumour sample from the primary tumor is mandatory.

    Objectives: The primary objective is to assess the effect of adjuvant treatment with olaparib on Invasive Disease Free Survival (IDFS. Secondary objectives aretTo assess the effect of adjuvant treatment with olaparib on overall survival (OS), to assess the effect of adjuvant treatment with olaparib on Distant Disease Free Survival (DDFS), to assess the effect of adjuvant treatment with olaparib on the incidence of new invasive breast primary cancer and/or new epithelial ovarian cancer, to assess the effect of olaparib on patient reported outcomes using the FACIT fatigue scale and EORTC QLQ-C30 QoL scale and to assess efficacy of olaparib in patients identified as having a deleterious or suspected deleterious variant in either of the BRCA genes using variants identified with current and future BRCA mutation assays (gene sequencing and large rearrangement analysis).

    NCT Registration ID (from clinicaltrials.gov): NCT02032823
    Participation: Limited to invited centres; Site Selection Closed
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: July 20, 2015 Closing Date: April 29, 2019



    		Closed to Accrual
    MAC15 (SWOG S1007)

    A Phase III Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy Plus or Minus Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer with Recurrence Score (RS) of 25 or Less. RxPONDER: A Clinical Trial Rx For Positive Node, Endocrine Responsive Breast Cancer.


    A Phase III Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy Plus or Minus Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer with Recurrence Score (RS) of 25 or Less. RxPONDER: A Clinical Trial Rx For Positive Node, Endocrine Responsive Breast Cancer.

    Complexity Level: 3

    Eligibility: Patients must have a histologically confirmed diagnosis of node positive (1-3 nodes) invasive breast carcinoma with positive estrogen and/or progesterone receptor status, and negative HER-2 status.

    Objectives: Primary: Disease Free Survival Secondary: Overall survival; EFS; Economic; QoL; A biologic correlate

    NCT Registration ID (from clinicaltrials.gov): NCT01272037
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: October 05, 2011 Closing Date: October 15, 2015



    		Closed to Accrual
    MA41 (BIG 19-02)

    De-Escalation of adjuvant ChemotheRapy in HER-2 positive, EStrogen reCEptor-negative, Node-negative, early breast cancer patients who achieved pathological complete response after neoadjuvant chemotherapy and Dual HER-2 blOckade (DECRESCENDO)


    De-Escalation of adjuvant ChemotheRapy in HER-2 positive, EStrogen reCEptor-negative, Node-negative, early breast cancer patients who achieved pathological complete response after neoadjuvant chemotherapy and Dual HER-2 blOckade (DECRESCENDO)

    Complexity Level: 2

    Eligibility: Male or female, > or = 18 years old, ECOG 0 or 1,tumour measures 15 to 50 mm, histologically confirmed diagnosis of HER2-positive and ER-negative/PR-negative breast cancer, ER-negative/PR-negative, N0, left ventricular ejection fraction > or = 55%,

    Objectives: To evaluate 3-year RFS in subjects with HER2-enriched, ER-negative/PR-negative, clinically node-negative breast cancers who achieve a pCR after neoadjuvant treatment with weekly paclitaxel (or docetaxel every 3 weeks) and dual HER2 blockade with pertuzumab and trastuzumab FDC SC. To evaluate 3-year RFS in all subjects with HER2-positive, ER-negative/PR-negative, clinically node-negative breast cancers who achieve a pCR after neoadjuvant treatment with weekly paclitaxel (or docetaxel every 3 weeks) and dual HER2 blockade with pertuzumab and trastuzumab FDC SC. To assess pCR rates in the overall population and by primary tumour dimension, 3-year RFS, Recurrence-free interval (RFI), 3-year invasive disease-free survival (iDFS), 3-year distant disease-free survival (dDFS), 3-year overall survival (OS).

    NCT Registration ID (from clinicaltrials.gov): NCT04675827
    Participation: Limited to invited centres; Site Selection Open
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: January 27, 2023 Closing Date: October 02, 2023



    		Closed to Accrual
    MA40

    A Double-Blind Placebo Controlled Randomized Phase III Trial of Fulvestrant and Ipatasertib as Treatment for Advanced HER-2 Negative and Estrogen Receptor Positive (ER+) Breast Cancer Following Progression on First Line CDK 4/6 Inhibitor and Aromatase Inhibitor (FINER)


    A Double-Blind Placebo Controlled Randomized Phase III Trial of Fulvestrant and Ipatasertib as Treatment for Advanced HER-2 Negative and Estrogen Receptor Positive (ER+) Breast Cancer Following Progression on First Line CDK 4/6 Inhibitor and Aromatase Inhibitor (FINER)

    Complexity Level: 2

    Eligibility: INCLUSION CRITERIA: Histologically/cytologically confirmed ER+, HER2- breast cancer. Females must be post-menopausal or pre-menopausal with ovarian supression using LHRH agonist. Clinical/radiographic progression during treatment with/within 28 days of discontinuation of 1st line treatment with CDK4/6 inhibitor and AI for advanced disease. Clinicallyradiologically documented disease. 18 years of age or older. ECOG 0 or 1. No concurrent anti-cancer therapy. Must not have received > 1 prior line of treatment with a CDK 4/6 inhibitor + AI in advanced setting. Treatment with CDK 4/6 inhibitor + AI must be most recent treatment. Adequate hematology and organ function.MAIN EXCLUSION CRITERIA: Untreated or symptomatic CNS metastases, radiation for CNS within 28 days. Active inflammatory bowel disease. Prior treatment with fulvestrant, SERDs or PI3K inhibitors. QTc>/=480 msec. Active infections. Type 1/2 diabetes requiring insulin. Hypercholesterolemia. Coagulation disorders.

    Objectives: PRIMARY: Investigator assessed PFS (per RECIST 1.1) in ipatasertib + fulvestrant vs. placebo + fulvestrant arms SECONDARY: compare treatment arms with respect to investigator assessed PFS in PIK3CA/AKT1/PTEN altered cohort, investigator assessed PFS in non-altered PIK3CA/AKT1/PTEN cohort, PFS as assessed by blinded central radiology review in all patients, response rate (RR) [per RECIST 1.1], duration of response (DoR), clincial benefit rate (CBR), overall survival (OS), time to commencement of subsequent line systemic therapy or death (TSST), safety and tolerability (CTCAE version 5.0). quality of life (QOL) (EORTC QLQ-C30 and PRO-CTCAE), economic evaluation (EQ-5D-5L). TERTIARY: compare PFS in two treatment arms based on PIK3CA/AKT1/PTEN altered status as determined using archival tissue, identification of prognostic biomarkers, creation of a biobank of FFPE, cfDNA, and digital images, characterize pharmacokinetics

    NCT Registration ID (from clinicaltrials.gov): NCT04650581
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Closed to Accrual
    Activation Date: December 01, 2020 Closing Date: May 07, 2024



    		Closed to Accrual
    MA37 (BIG 14-03)

    PALLAS: PALbociclib CoLlaborative Adjuvant Study: A Randomized Phase III Trial of Palbociclib with Standard Adjuvant Endocrine Therapy versus Standard Adjuvant Endocrine Therapy Alone for Hormone Receptor Positive (HR+)/ Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Early Breast Cancer


    PALLAS: PALbociclib CoLlaborative Adjuvant Study: A Randomized Phase III Trial of Palbociclib with Standard Adjuvant Endocrine Therapy versus Standard Adjuvant Endocrine Therapy Alone for Hormone Receptor Positive (HR+)/ Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Early Breast Cancer

    Complexity Level: 2

    Eligibility: Premenopausal and postmenopausal women or men with Stage II (Stage IIA limited to a maximum of 1000 patients) or Stage III early invasive breast cancer. Patients with multicentric and/or multifocal and/or bilateral early invasive breast cancer whose histopathologically examined tumors all meet pathologic criteria for ER+ and/or PR+ and HER2-. Patients must have histologically confirmed hormone receptor positive (ER+ and/or PR+), HER2-, early invasive breast cancer. A formalin-fixed paraffin-embedded (FFPE) tumor tissue block must be transmitted to a central sample repository and confirmation of receipt must be available prior to randomization.

    Objectives: To compare invasive disease-free survival (iDFS) for the combination of at least 5 years endocrine therapy and 2-year palbociclib treatment versus at least 5 years endocrine therapy alone in patients with histologically confirmed HR+/HER2- invasive early breast cancer (EBC). To compare the following endpoints: iDFS excluding second primary cancers of non-breast origin, distant recurrence-free survival (DRFS), locoregional recurrences-free survival (LRRFS), and overall survival (OS). To compare the safety of 2 years of palbociclib with adjuvant endocrine therapy versus adjuvant endocrine therapy alone.

    NCT Registration ID (from clinicaltrials.gov): NCT02513394
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: January 25, 2017 Closing Date: November 30, 2018



    		Closed to Accrual
    MAC11 (SWOG S0221)

    A Phase III Trial of Continuous Schedule AC + G vs Q2 Week Schedule AC, Followed by Paclitaxel Given Either Every 2 Weeks or Weekly for 12 Weeks as Post-Operative Adjuvant Therapy in Node-Positive or High-Risk Node-Negative Breast Cancer.


    A Phase III Trial of Continuous Schedule AC + G vs Q2 Week Schedule AC, Followed by Paclitaxel Given Either Every 2 Weeks or Weekly for 12 Weeks as Post-Operative Adjuvant Therapy in Node-Positive or High-Risk Node-Negative Breast Cancer.

    Complexity Level: 2

    Eligibility: Patients must be women or men with histological confirmed diagnosis of operable Stage I, II, or III invasive breast cancer with known Estrogen and Progesterone status. Patients with T4 tumours are not eligible.

    Objectives: To compare the disease-free survival of patients with node-positive or high-risk node-negative breast cancer treated with 4 different schedules of adjuvant doxorubicin, cyclophosphamide, and paclitaxel. To comapre the overall survival, toxic effects and to correlate outcome with putative prognostic markers in patients treated with these regimens.

    NCT Registration ID (from clinicaltrials.gov): NCT00070564
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: November 22, 2006 Closing Date: January 15, 2012



    		Closed to Accrual
    MA32D (ALLIANCE A211201)

    Change In Mammographic Density with Metformin Use: A Companion Study to NCIC CTG Study MA.32


    Change In Mammographic Density with Metformin Use: A Companion Study to NCIC CTG Study MA.32

    Complexity Level: 3

    Eligibility: Eligible patients must be either concurrently enrolling or previously enrolled to NCIC study MA.32. Eligible patients may be either pre- or post-menopausal. Patients must have hormone receptor-negative breast cancer. Patients must have breast density measurement as defined by either: >/= 25% density, or fibroglandular densities, or BIRAD-2 category or greater. Baseline digital mammograms taken within 12 months prior to registration to MA.32, with at least a craniocaudal (CC) view used for enrollment to NCIC MA.32 must be available for submission. If the patient has previously enrolled to MA.32 and one year has elapsed from baseline mammograms, one-year mammograms must also be available for submission. Women receiving endocrine therapy (e.g., tamoxifen, aromatase inhibitors) are not eligible. Contralateral unaffected breast in place (with no prior cancer or radiation, no implants and no plan for breast surgery on contralateral breast over the course of the study).

    Objectives: To evaluate the change in percent mammographic density in contralateral (unaffected breast) from prior to the initiation of metformin or placebo treatment through one year of therapy in patients with hormone receptor negative breast cancer (i.e. not on endocrine therapy).

    NCT Registration ID (from clinicaltrials.gov): NCT01666171
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: March 18, 2015 Closing Date: October 13, 2017



    		Closed to Accrual
    MA33 (TROG 0701)

    A Randomised Phase III Study Of Radiation Doses And Fractionation Schedules For Ductal Carcinoma In Situ (DCIS) Of The Breast


    A Randomised Phase III Study Of Radiation Doses And Fractionation Schedules For Ductal Carcinoma In Situ (DCIS) Of The Breast

    Complexity Level: 2

    Eligibility: Women with DCIS, radial margins >1 mm post-breast conserving therapy.

    Objectives: Time of local recurrence Overall survival; disease-free survival; cosmetic outcome, acute and late toxicity; correlative studies.

    NCT Registration ID (from clinicaltrials.gov): NCT00470236
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: April 29, 2009 Closing Date: June 20, 2014



    		Closed to Accrual
    MA15

    A Phase I/II Study of Docetaxel and Epirubicin as First Line Therapy for Metastatic Breast Cancer


    A Phase I/II Study of Docetaxel and Epirubicin as First Line Therapy for Metastatic Breast Cancer

    NCT Registration ID (from clinicaltrials.gov): NCT00002866
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 12, 1996 Closing Date: March 20, 2001



    		Permanently Closed
    MA28 (NCCTG N9831)

    Phase III Trial of Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Paclitaxel With or Without Trastuzumab as Adjuvant Treatment For Women With HER-2 Over-Expressing or Amplified Node Positive or High-Risk Node Negative Breast Cancer


    Phase III Trial of Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Paclitaxel With or Without Trastuzumab as Adjuvant Treatment For Women With HER-2 Over-Expressing or Amplified Node Positive or High-Risk Node Negative Breast Cancer

    Complexity Level: 2

    Eligibility: Operable, histologically confirmed adenocarcinoma of the female breast and positive lymph nodes. Operable, histologically confirmed adenocarcinoma of the female breast and negative lymph nodes. =84 days from mastectomy or =84 days from axillary dissection or sentinel node detection if the patient's most extensive breast surgery was a breast sparing procedure. (This timing is per a decision by the Breast Intergroup.) TAM therapy =18 years of age with any menopausal status. Adequate bone marrow function. Adequate hepatic function Left ventricular ejection fraction (LVEF) within institutional normal range. If LVEF is > 75%, the investigator should consider performing a second review of the MUGA/echocardiogram or performing a repeat MUGA/echocardiogram prior to registration. Such re-reviews or repeat MUGA/echocardiogram are not permitted after registration

    Objectives: To compare the combination AC followed by weekly paclitaxel with the sequential schedule of the combination of AC, weekly paclitaxel, and trastuzumab in terms of disease-free survival (DFS). To compare the combination of AC followed by weekly paclitaxel with the combination of AC followed by the combination of weekly paclitaxel and trastuzumab in terms of DFS. To compare the sequential schedule of AC, weekly paclitaxel, and trastuzumab with the combination of AC followed by the combination of weekly paclitaxel and trastuzumab in terms of DFS. To compare the cardiotoxicities of 1) AC followed by weekly paclitaxel, 2) AC followed by weekly paclitaxel followed by weekly trastuzumab, and 3) AC followed by weekly paclitaxel and trastuzumab followed by weekly trastuzumab To compare the combination of AC followed by weekly paclitaxel with the sequential schedule of the combination of AC, weekly paclitaxel, and trastuzumab in terms of overall survival (OS).

    NCT Registration ID (from clinicaltrials.gov): NCT00005970
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed Closing Date: April 25, 2005



    		Permanently Closed
    MAP3B

    The Influence of Five Years of Exemestane on Bone Mineral Density in Postmenopausal Women at Increased Risk of Developing Breast Cancer - A Companion Study to MAP.3


    The Influence of Five Years of Exemestane on Bone Mineral Density in Postmenopausal Women at Increased Risk of Developing Breast Cancer - A Companion Study to MAP.3

    Complexity Level: 3

    Eligibility: Woman randomized to MAP.3 with: a BMD of Spine (L1-L4)or Total Hip and Femoral Neck, T score >= -1.9 sd are eligible for this study.

    Objectives: To examine whether there is clinically relevant difference in impact on BMD between exemestane and placebo after two years from randomization to the core protocol.

    NCT Registration ID (from clinicaltrials.gov): NCT00688246
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 23, 2008 Closing Date: March 23, 2010



    		Permanently Closed
    MA12

    Double-Blind Randomized Trial of Tamoxifen versus Placebo in Patients with Node Positive or High Risk Node Negative Breast Cancer Who Have Completed CMF, CEF, or AC Adjuvant Chemotherapy


    Double-Blind Randomized Trial of Tamoxifen versus Placebo in Patients with Node Positive or High Risk Node Negative Breast Cancer Who Have Completed CMF, CEF, or AC Adjuvant Chemotherapy

    NCT Registration ID (from clinicaltrials.gov): NCT00002542
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 20, 1993 Closing Date: April 28, 2000



    		Permanently Closed
    MAC4 (IBCSG 24-02)

    A Phase III Trial Evaluating the Role of Ovarian Function Suppression and the Role of Exemestane as Adjuvant Therapies for Premenopausal Women With Endocrine Responsive Breast Cancer


    A Phase III Trial Evaluating the Role of Ovarian Function Suppression and the Role of Exemestane as Adjuvant Therapies for Premenopausal Women With Endocrine Responsive Breast Cancer

    Complexity Level: 2

    Eligibility: Premenopausal women (estradiol (E2) levels in the premenopausal range) with histologically proven, resected breast cancer with ER and/or PR positive tumors who have received either no chemotherapy or remain premenopausal following completion of adjuvant and/or neoadjuvant chemotherapy.

    Objectives: This trial will evaluate the worth of ovarian function suppression (achieved by either long-term use of GnRH analogue or surgical oophorectomy or ovarian irradiation) plus tamoxifen compared with tamoxifen alone for premenopausal women with steroid hormone receptor positive early invasive breast cancer who either receive no adjuvant chemotherapy or remain premenopausal following adjuvant and/or neoadjuvant chemotherapy. In addition, the worth of exemestane will be evaluated for this premenopausal patient population by comparing ovarian function suppression plus exemestane with tamoxifen alone and by comparing ovarian function suppression plus exemestane with ovarian function suppression plus tamoxifen.

    NCT Registration ID (from clinicaltrials.gov): NCT00066690
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: October 07, 2003 Closing Date: April 30, 2010



    		Permanently Closed
    MA17B

    The Influence of Letrozole on Bone Mineral Density in Women With Primary Breast Cancer Completing Five or More Years of Adjuvant Tamoxifen -- a Companion Study to MA.17


    The Influence of Letrozole on Bone Mineral Density in Women With Primary Breast Cancer Completing Five or More Years of Adjuvant Tamoxifen -- a Companion Study to MA.17

    Eligibility: Eligible women will have a BMD T score greater than or equal to 2.0 SD below the mean value of peak bone mass in young normal women. They must not have malabsorption syndrome, clinically relevant vitamin D deficiency, active hyper- or hypoparathyroidism, Paget¿s disease, uncontrolled thyroid disease, Cushing¿s disease, other pituitary diseases, or other bone diseases. Women must not have received previous treatment with anticonvulsants or anabolic steroids within the past 12 months, high doses of corticosteroids or sodium fluoride for an extended time, any drug including bisphosphonates for the prevention of osteoporosis within the past six months, or long term use of coumarins.

    Objectives: To evaluate the effects of letrozole on bone mineral density in post-menopausal women treated with letrozole or placebo following at least five years of adjuvant tamoxifen therapy for breast cancer.

    NCT Registration ID (from clinicaltrials.gov): no NCT
    Participation: Limited to MA.17 participants
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 26, 2000 Closing Date: August 30, 2002



    		Permanently Closed
    MA25 (S9927)

    Randomized Trial of Post-Mastectomy Radiotherapy in Stage II Breast Cancer in Women With One to Three Positive Axillary nodes


    Randomized Trial of Post-Mastectomy Radiotherapy in Stage II Breast Cancer in Women With One to Three Positive Axillary nodes

    Eligibility: Women with histologically confirmed adenocarcinoma of the breast, with the primary tumour < 5 cm and 1-3 positive axillary nodes (pathologic T1-2, pathologic N1). Patients with apocrine, adenocystic, or squamous carcinomas or sarcomas of the breast or bilateral breast cancer are not eligible.

    Objectives: To compare overall and disease-free survival in pre- and post-menopausal women with Stage II breast cancer and 1 ¿ 3 positive nodes treated with or without radiation therapy following mastectomy and adjuvant chemotherapy. To assess local-regional control for this cohort of patients. To assess the potential toxicities of radiotherapy delivered using CT-directed treatment in this cohort of patients.

    NCT Registration ID (from clinicaltrials.gov): NCT00005983
    Participation: Limited to centres with current CPA/FWA #
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: November 22, 2001 Closing Date: June 15, 2003



    		Permanently Closed
    MA11

    A Phase I Study of Escalating Epirubicin and Cyclophosphamide in Combination with 5-Fu Using Granulocyte Colony Stimulating Factor Support in Premenopausal Women With Axillary Node Positive Operable Breast Cancer


    A Phase I Study of Escalating Epirubicin and Cyclophosphamide in Combination with 5-Fu Using Granulocyte Colony Stimulating Factor Support in Premenopausal Women With Axillary Node Positive Operable Breast Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 30, 1993 Closing Date: August 24, 1995



    		Permanently Closed
    MAC7 (SWOG S0226)

    Phase III Randomized Trial of Anastrozole Versus Anastrozole and Fulvestrant as First Line Therapy for Post Menopausal Women With Metastatic Breast Cancer


    Phase III Randomized Trial of Anastrozole Versus Anastrozole and Fulvestrant as First Line Therapy for Post Menopausal Women With Metastatic Breast Cancer

    Complexity Level: 2

    Eligibility: Post menopausal women with metastatic breast cancer

    Objectives: To compare time to tumour progression in post-menopausal women with metastatic breast cancer treated with anastrozole versus anastrozole and fluvestrant.

    NCT Registration ID (from clinicaltrials.gov): NCT00075764
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: January 23, 2006 Closing Date: July 01, 2009



    		Permanently Closed
    MA1

    NCIC Cooperative Clinical Trial of Tamoxifen versus Ovarian Ablation in the Treatment of Metastatic Breast Carcinoma in Premenopausal Women


    NCIC Cooperative Clinical Trial of Tamoxifen versus Ovarian Ablation in the Treatment of Metastatic Breast Carcinoma in Premenopausal Women

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 06, 1981 Closing Date: May 30, 1983



    		Permanently Closed
    MAC4C (IBCSG ANZ0701)

    Investigating Cognitive Function For Patients Participating In The SOFT Trial In Selected Centers


    Investigating Cognitive Function For Patients Participating In The SOFT Trial In Selected Centers

    Complexity Level: 3

    Eligibility: - Patient registered for the parent SOFT study but not yet started protocol hormonal therapy. - Patient has not yet received any adjuvant endocrine therapy (i.e. no tamoxifen, exemestane, GnRH agonist, bilateral oophorectomy, ovarian irradiation), either before or after registration on the SOFT trial. Patients who have commenced adjuvant endocrine therapy prior to registration on the parent SOFT protocol are not eligible for this sub-study. - Patient can speak and read the local language(s) fluently. - Written informed consent must be obtained. The informed consent must be kept in the patient¿s records at the participating site and be available for monitoring, auditing, and Health Authority inspection.

    Objectives: The primary objective is to evaluate and compare changes in cognitive function over 1 year in premenopausal BC patients who receive adjuvant tamoxifen (T) with or without ovarian function suppression (OFS). We hypothesise that women who receive T + OFS will show greater deterioration in cognitive function than those who receive T alone.

    Participation: Limited to invited centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: June 09, 2008 Closing Date: April 30, 2010



    		Permanently Closed
    MA27 (MA27)

    A Randomized Phase III Trial of Exemestane Versus Anastrozole in Postmenopausal Women with Receptor Positive Primary Breast Cancer


    A Randomized Phase III Trial of Exemestane Versus Anastrozole in Postmenopausal Women with Receptor Positive Primary Breast Cancer

    Eligibility: Post-menopausal women who have histologically or cytologically confirmed, receptor-positive, adequately excised, primary breast cancer are eligible for this trial. Adjuvant chemotherapy and radiation are allowable. Chemotherapy must be completed before randomization. Radiotherapy may be given prior to or concurrently with protocol therapy.

    Objectives: To compare event free survival (EFS) between women treated with Exemestane or Anastrozole as adjuvant therapy. To compare the incidence of contralateral breast cancer, the time to distant recurrence, survival & safety among treatment groups.

    NCT Registration ID (from clinicaltrials.gov): NCT00066573
    Participation: NCIC CTG, CTSU sites, IBCSG
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 02, 2003 Closing Date: July 31, 2008



    		Permanently Closed
    MA5

    Cooperative Clinical Trial of Intensive CEF versus Standard CMF as Adjuvant Therapy for Breast Carcinoma in Premenopausal Patients With Histologically Involved Axillary Nodes


    Cooperative Clinical Trial of Intensive CEF versus Standard CMF as Adjuvant Therapy for Breast Carcinoma in Premenopausal Patients With Histologically Involved Axillary Nodes

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: December 01, 1989 Closing Date: July 30, 1993



    		Permanently Closed
    MA7A

    Phase I Study of Fluorouracil With Folinic Acid, Doxorubicin and Vinorelbine (SuperFAN) in Patients With Advanced Breast Cancer


    Phase I Study of Fluorouracil With Folinic Acid, Doxorubicin and Vinorelbine (SuperFAN) in Patients With Advanced Breast Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: March 10, 1992 Closing Date: May 24, 1994



    		Permanently Closed
    MA27D (N0434)

    The Association of Breast Density Changes, Plasma Hormone Changes, and Breast Cancer Recurrence: A Companion Study to NCIC CTG MA.27


    The Association of Breast Density Changes, Plasma Hormone Changes, and Breast Cancer Recurrence: A Companion Study to NCIC CTG MA.27

    Eligibility: MA.27 patients with one intact non-cancerous breast with no hormone, SERM or GnRHA therapy within the past 12 months and no hormone, SERM or GnRHA therapy within 6 months prior to the pre-registration mammogram are eligible for this companion study to MA.27

    Objectives: To assess the change in percent breast density and change in dense area in response to aromatase inhibitor therapy, whether these changes correlate with changes in plasma hormones and whether these changes, over time, are associated with recurrence of breast cancer

    NCT Registration ID (from clinicaltrials.gov): NCT00316836
    Participation: Limited to MA.27 participants
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: April 24, 2006 Closing Date: July 31, 2008



    		Permanently Closed
    MA2

    Pilot Study of Sequential Hormono-Chemotherapy in Metastatic Breast Carcinoma


    Pilot Study of Sequential Hormono-Chemotherapy in Metastatic Breast Carcinoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: December 04, 1981 Closing Date: August 20, 1982



    		Permanently Closed
    MA17R (MA17R)

    A Double Blind Randomization to Letrozole or Placebo for Women Previously Diagnosed with Primary Breast Cancer Completing Five Years of Adjuvant Aromatase Inhibitor Either as Initial Therapy or After Tamoxifen (Including Those in the MA.17 Study)


    A Double Blind Randomization to Letrozole or Placebo for Women Previously Diagnosed with Primary Breast Cancer Completing Five Years of Adjuvant Aromatase Inhibitor Either as Initial Therapy or After Tamoxifen (Including Those in the MA.17 Study)

    Complexity Level: 2

    Eligibility: Women completing around five years of aromatase inhibitor therapy, either as initial therapy or after tamoxifen, including those who received letrozole within the MA.17 study, are eligible for randomization to a further five years of letrozole or placebo. Eligible subjects must be free of recurrent breast cancer and have completed the five years of aromatase inhibitor therapy no more than 2 years prior to randomization. BMD measured by DEXA should be done within 4 weeks prior to randomization if not done within the previous 12 months, but the results do not affect eligibility.

    Objectives: To compare the disease-free survival of subjects who receive 5 years of letrozole or placebo after having received around 5 years (4.5 - 6) of aromatase inhibitor therapy (letrozole, anastrozole, or exemestane) including those who received 5 years of adjuvant letrozole as part of the MA.17 trial. To evaluate the effect on overall (all cause specific) mortality. To evaluate the incidence of contralateral breast cancer. To evaluate the long term clinicial and laboratory safety of aromatase inhibitor therapy which includes 5 years of letrozole therapy. To evaluate overall quality of life (SF-36) and menopausal specific QOL (Menqol). To test the hypothesis that common genetic polymorphisms for genes encoding proteins involved in pharmacokinetic and/or pharmacodynamic pathways for the aromatase inhibitor letrozole contribute to individual variation in toxicity and efficacy of letrozole therapy.

    NCT Registration ID (from clinicaltrials.gov): NCT00754845
    Participation: Open to centres in participating cooperative groups.
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: October 14, 2004 Closing Date: May 08, 2009



    		Permanently Closed
    MA8

    A Phase III Comparative Study of Vinorelbine Combined With Doxorubicin versus Doxorubicin Alone in Disseminated Metastatic/Recurrent Breast Cancer


    A Phase III Comparative Study of Vinorelbine Combined With Doxorubicin versus Doxorubicin Alone in Disseminated Metastatic/Recurrent Breast Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 15, 1992 Closing Date: July 17, 1995



    		Permanently Closed
    MA6A

    Phase I Study of Fluorouracil, Doxorubicin and Vinorelbine (FAN) in Patients With Advanced Breast Cancer


    Phase I Study of Fluorouracil, Doxorubicin and Vinorelbine (FAN) in Patients With Advanced Breast Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: March 06, 1992 Closing Date: July 07, 1994



    		Permanently Closed
    MAC14 (ECOG-ACRIN 2108)

    A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients with Metastatic Breast Cancer


    A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients with Metastatic Breast Cancer

    Complexity Level: 2

    Eligibility: 3.1 Registration (STEP 1) 3.1.1 Patients (male or female) must have an intact primary (not recurrent) invasive carcinoma of the breast. Biopsy confirmation of the primary tumor should be by needle biopsy (preferred); incisional surgical biopsy is allowed as long as there is residual palpable or imageable tumor in the breast. 3.1.2 Patients with synchronous contralateral breast cancer are excluded. 3.1.3 Patients should have at least one site of distant metastatic disease. If only a single metastatic lesion is present, biopsy is mandatory. See Section 3.1.6. 3.1.4 Radiology reports documenting status of disease prior to initiation of systemic therapy must be available. Scans must have been completed within 4 weeks prior to start of systemic therapy. 3.1.5 If patient has only one site of metastatic disease, this must be proven by biopsy and the pathology report confirming the diagnosis of primary breast cancer, as well as the metastatic site, must be available. Single metastatic lesion?

    Objectives: Primary Objectives To evaluate whether early local therapy of intact primary disease in women with Stage IV breast cancer whose disease does not progress during initial optimal systemic therapy, will result in prolonged survival, compared to women who receive local therapy for palliation only

    NCT Registration ID (from clinicaltrials.gov): NCT01242800
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: June 22, 2011 Closing Date: July 23, 2015



    		Permanently Closed
    MAP1

    A Randomized Feasibility Study of Letrozole in Postmenopausal Women at Increased Risk for Development of Breast Cancer as Evidenced by High Breast Density


    A Randomized Feasibility Study of Letrozole in Postmenopausal Women at Increased Risk for Development of Breast Cancer as Evidenced by High Breast Density

    Eligibility: Healthy, postmenopausal women or those postmenopausal women who have had prior breast cancer with a receptor positive tumour, either ER or PR or equivocal or unknown breast cancer or who have had prior DCIS (receptor status not required), who have either not had adjuvant endocrine therapy or are more than six months from the completion of adjuvant endocrine therapy and who are eligible by virtue of the appearance of increased radiological density, grade 4, 5 or 6, on routine mammographic screening

    Objectives: To determine the proportion of women who have a decrease in breast density of at least one grade after treatment for one year; to determine if the decrease in density grade is sustained one year after cessation of therapy; to evaluate specific changes related to other end-organ effects i.e. bone density, lipid metabolism, etc.

    NCT Registration ID (from clinicaltrials.gov): NCT00238316
    Participation: Not limited
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: December 05, 2000 Closing Date: June 09, 2006



    		Permanently Closed
    MAX1 (QMUL LATTE)

    Long term Anastrozole vs Tamoxifen Treatment Effects (LATTE)


    Long term Anastrozole vs Tamoxifen Treatment Effects (LATTE)

    Complexity Level: 3

    Eligibility: Patients must satisfy the following criteria to be eligible for entry into this study: patients randomised to one of the monotherapy arms in the ATAC Trial alive at 10 years follow-up

    Objectives: Primary objectives The primary objectives of this study are to compare the long-term effects of tamoxifen (20 mg od) and anastrozole (1 mg od) which were given in the ATAC trial (and who have all now completed treatment + 5 years follow-up) as adjuvant therapy in terms of: Time to recurrence of breast cancer in the post 10 year period (defined as the earliest of local or distant recurrence, new primary breast cancer, or death) Death after recurrence Secondary objectives The secondary objectives of this study are to compare the long-term effects of tamoxifen (20 mg od) and anastrozole (1 mg od) which were given in the ATAC trial (and who have all now completed treatment) as adjuvant therapy in terms of: Time to distant recurrence Cancer-specific survival New breast primaries Other cancers Ischaemic cardiac and cerebrovascular events Hip (and other) fractures

    NCT Registration ID (from clinicaltrials.gov): NCT01745289
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: June 21, 2016 Closing Date: January 21, 2019



    		Permanently Closed
    MAP2

    A Randomized Study of the Effect of Exemestane (Aromasin) versus Placebo on Breast Density in Postmenopausal Women at Increased Risk for Development of Breast Cancer


    A Randomized Study of the Effect of Exemestane (Aromasin) versus Placebo on Breast Density in Postmenopausal Women at Increased Risk for Development of Breast Cancer

    Eligibility: Healthy, postmenopausal women who have increased radiological density occupying >25% of the breast tissue on routine screening mammogram.

    Objectives: To determine whether treatment with exemestane for one year in women with spontaneously increased breast density leads to a decrease in breast density of at least >1 grade 12 months after randomization; to determine if the decrease in breast density grade is sustained one year after stopping treatment; to determine the correlation between the grade of breast density and bone density at base line and at 12 months; to assess overall safety (bone and lipid metabolism, toxicity); to compare menopause-specific quality of life.

    NCT Registration ID (from clinicaltrials.gov): NCT00066586
    Participation: Not limited
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 01, 2001 Closing Date: June 09, 2006



    		Permanently Closed
    MA32F (NSABP MA32F)

    Biobehavioral Mechanisms of Fatigue in Patients Treated on NCIC CTG MA.32: A Phase III Randomized Trial of Metformin Versus Placebo on Recurrence and Survival in Early Stage Breast Cancer (NCIC CTG MA.32 Ancillary Study led by the National Surgical Adjuvant Breast and Bowel Project)


    Biobehavioral Mechanisms of Fatigue in Patients Treated on NCIC CTG MA.32: A Phase III Randomized Trial of Metformin Versus Placebo on Recurrence and Survival in Early Stage Breast Cancer (NCIC CTG MA.32 Ancillary Study led by the National Surgical Adjuvant Breast and Bowel Project)

    Complexity Level: 3

    Eligibility: - The patient must have consented to participate and must have signed and dated an appropriate IRB-approved consent form that confirms to federal and institutional guidelines for the MA32F Study before being enrolled. - The patient must be female and reside in the United States or Canada. - The patient must be english speaking. - Patient must be eligible for randomization in the MA32 treatment trial. - The patient must not have started taking MA32 study therapy. - The patient must have completed primary breast radiation therapy at least two weeks prior to enrollment in MA32F. The patient is considered ineligible if: - MA32 therapy has been initiated. - Patient currently receiving radiation therapy or additional radiation therapy is planned for initiation after starting MA32 study therapy.

    Objectives: - Determine the biological correlates of fatigue in breast cancer patients in the years following MA32 randomization and initiation of metformin or placebo. - Determine if specific SNPs in the promoter regions of IL-1 and IL-6 are associated with circulating markers of inflammation and fatigue in the years following MA32. - Determine which RNA gene expression pathways are associated with fatigue in metformin-treated patients and how do they relate to RNA gene expression pathways in untreated patients. - Determine the biological and behavorial predictors of fatigue in breast cancer patients in the years post-randomization. - Determine if metformin will be associated with reductions in inflammatory markers and corresponding decreases in fatigue.

    NCT Registration ID (from clinicaltrials.gov): NCT01286233
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: October 28, 2011 Closing Date: January 25, 2013



    		Permanently Closed
    MA20

    A Phase III Study of Regional Radiation Therapy in Early Breast Cancer


    A Phase III Study of Regional Radiation Therapy in Early Breast Cancer

    Complexity Level: 2

    Eligibility: Pre or post menopausal women with node positive and high risk node-negative breast cancer treated by breast conserving therapy and currently accepted adjuvant chemotherapy and/or hormonal therapy.

    Objectives: To determine if regional radiation therapy (to the ipsilateral supraclavicular, axillary and internal mammary nodes) in addition to breast radiation prolongs survival in women with early breast cancer compared with breast radiation alone. To compare disease free survival, isolated local regional disease-free survival, and distant disease free survival. To evaluate toxicity. To evaluate quality of life. To determine the cosmetic outcome of these two treatment approaches.

    NCT Registration ID (from clinicaltrials.gov): NCT00005957
    Participation: Not limited.
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: December 14, 1999 Closing Date: February 02, 2007



    		Permanently Closed
    MAC3 (E2100)

    A Randomized Phase III Trial of Paclitaxel Versus Paclitaxel Plus Bevacizumab (rhuMAb VEGF) as First-Line Therapy for Locally Recurrent or Metastatic Breast Cancer.


    A Randomized Phase III Trial of Paclitaxel Versus Paclitaxel Plus Bevacizumab (rhuMAb VEGF) as First-Line Therapy for Locally Recurrent or Metastatic Breast Cancer.

    Eligibility: Patients must have histologically or cytologically confirmed adenocarcinoma of the breast with measurable or nonmeasurable locally recurrent or metastatic disease. Locally recurrent disease must not be amenable to resection with curative intent. All scans or x-rays used to document measurable or nonmeasurable disease must be done within 4 weeks prior to randomization. Patients with breast cancer overexpressing HER-2 (gene amplification by FISH or 3+ overexpression by immunohistochemistry) are not eligible unless they have received prior therapy with Herceptin. HER-2 testing is strongly encouraged. Therefore patients with unknown HER-2 status are not eligible unless the treating physician has determined that Herceptin-based therapy would be inappropriate or not indicated. Patients must not have had prior chemotherapy for locally recurrent or metastatic breast cancer. Prior hormonal therapy for locally recurrent or metastatic disease is allowed, but this must have been discontinued

    Objectives: To determine the time to treatment failure of patients with chemotherapy naive metastatic breast cancer randomized to treatment with either paclitaxel alone or paclitaxel plus bevacizumab. To compare the objective response rate, duration of response, overall survival and time to progression of paclitaxel to that of the combination of paclitaxel plus bevacizumab. To compare the toxicity of paclitaxel to that of paclitaxel in combination with bevacizumab. To compare the quality of life (FACT-B) of patients treated with paclitaxel to that of the combination of paclitaxel plus bevacizumab as first-line therapy for metastatic breast cancer. To compare changes in surrogate markers of angiogenesis and response including VEGF and VCAM-1 expression during treatment with paclitaxel to that of paclitaxel plus bevacizumab.

    NCT Registration ID (from clinicaltrials.gov): NCT00028990
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: June 26, 2002 Closing Date: May 26, 2004



    		Permanently Closed
    MA19

    A Phase III Study of DPPE (BMS-217380-01) Combined With Doxorubicin versus Doxorubicin Alone in Metastatic/Recurrent Breast Cancer


    A Phase III Study of DPPE (BMS-217380-01) Combined With Doxorubicin versus Doxorubicin Alone in Metastatic/Recurrent Breast Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: February 09, 1998 Closing Date: July 08, 1999



    		Permanently Closed
    MA9C (8854)

    Prognostic Factor Panel to Predict Preferred Therapy for Node-Positive Postmenopausal Breast Cancer Patients


    Prognostic Factor Panel to Predict Preferred Therapy for Node-Positive Postmenopausal Breast Cancer Patients

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: May 01, 1996 Closing Date: October 01, 1998



    		Permanently Closed
    MAC21 (ALLIANCE A011502)

    A Randomized Phase III Double Blinded Placebo Controlled Trial of Aspirin as Adjuvant Therapy for HER2 Negative Breast Cancer: The ABC Trial


    A Randomized Phase III Double Blinded Placebo Controlled Trial of Aspirin as Adjuvant Therapy for HER2 Negative Breast Cancer: The ABC Trial

    Complexity Level: 3

    Eligibility: Histologic documentation of women or men with node-positive, HER2 negative, anatomic Stage II or III breast carcinoma or high risk node negative (defined as ER negative and tumor size >2 cm)within one year of diagnosis and free of recurrence. Patients with pN1mic are eligible. Patients must be enrolled within 1 year after diagnosis. Patients must be >= 18 and < 70 years of age. ECOG performance status 0-2. Any ER/PgR status allowed.

    Objectives: Primary Objective: To compare the effect of aspirin (300 mg daily) versus placebo upon invasive disease free survival (iDFS) in early stage node-positive HER2 negative breast cancer patients. Secondary Objectives: To compare the effect of aspirin versus placebo in early stage node-positive HER2 negative breast cancer patients upon: a) Distant disease-free survival, b) Overall survival, c) Cardiovascular disease, To compare the toxicity of aspirin versus placebo in early stage node-positive HER2 negative breast cancer patients. To assess adherence to aspirin and placebo among early stage node-positive HER2 negative breast cancer patients. To bank tumor and germline deoxyribonucleic acid (DNA), plasma and urine collected at baseline and sequential plasma and urine collected 2 years later for future measurement of inflammatory markers. To determine if there are subgroups of participants characterized by lifestyle factors associates with greater inflammation

    NCT Registration ID (from clinicaltrials.gov): NCT02927249
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: September 29, 2017 Closing Date: December 04, 2020



    		Permanently Closed
    MA17 (MA17)

    A Phase III Randomized Double Blind Study of Letrozole versus Placebo in Women with Primary Breast Cancer Completing Five or More Years of Adjuvant Tamoxifen


    A Phase III Randomized Double Blind Study of Letrozole versus Placebo in Women with Primary Breast Cancer Completing Five or More Years of Adjuvant Tamoxifen

    Complexity Level: 2

    Eligibility: Post-menopausal women who had receptor-positive breast cancer, or unknown receptor status breast cancer, and have completed at least five years of adjuvant tamoxifen therapy.

    Objectives: To compare disease-free survival and overall survival. To compare incidence of contralateral breast cancer, and long-term clinical and laboratory safety. To evaluate overall quality of life.

    NCT Registration ID (from clinicaltrials.gov): NCT00003140
    Participation: Open to centres in participating cooperative groups.
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 24, 1998 Closing Date: September 04, 2002



    		Permanently Closed
    MA13 (9082)

    A Randomized, Comparative Study of High Dose CPA/cDDP/BCNU and ABMS versus Standard Dose CPA/cDDP/BCNU as Consolidation to Adjuvant CAF for Patients with Operable Stage II or Stage II Breast Cancer Involving > 10 Axillary Lymph Nodes


    A Randomized, Comparative Study of High Dose CPA/cDDP/BCNU and ABMS versus Standard Dose CPA/cDDP/BCNU as Consolidation to Adjuvant CAF for Patients with Operable Stage II or Stage II Breast Cancer Involving > 10 Axillary Lymph Nodes

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: June 10, 1993 Closing Date: May 29, 1998



    		Permanently Closed
    MA23 (10951)

    Randomized Phase II-III Study in First Line Hormonal Treatment for Metastatic Breast Cancer With Exemestane or Tamoxifen in Postmenopausal Patients


    Randomized Phase II-III Study in First Line Hormonal Treatment for Metastatic Breast Cancer With Exemestane or Tamoxifen in Postmenopausal Patients

    Eligibility: Postmenopausal patients with locally recurrent inoperable or metastatic carcinoma of the breast. Patients must have had histologically or cytologically confirmed adenocarcinoma of the breast at original diagnosis. At study entry the patient must have had metastatic progressive or locally recurrent inoperative breast cancer. Patients must have positive estrogen or progesterone receptor status at the time of original diagnosis or subsequently at a metastatic site.

    Objectives: To determine if a hormonal therapy with exemestane is superior in terms of progression-free survival to tamoxifen in first line advanced breast cancer. To further document the safety profile of exemestane and to compare overall survival between the treatment arms.

    NCT Registration ID (from clinicaltrials.gov): NCT00002777
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: August 08, 2001 Closing Date: September 20, 2002



    		Permanently Closed
    MAC8 (NSABP B-37)

    A Randomized Clinical Trial of Adjuvant Chemotherapy for Radically Resected Loco-Regional Relapse of Breast Cancer.


    A Randomized Clinical Trial of Adjuvant Chemotherapy for Radically Resected Loco-Regional Relapse of Breast Cancer.

    Complexity Level: 2

    Eligibility: Histologically proven local &/or regional recurrence of invasive breast cancer following primary treatment with mastectomy or breast conserving treatment. Surgical resection with radiotherapy (ro) or (ri). No evidence of distant mets. Measurement of hormone receptors in the recurrent tumour. Medically suitable for chemo of 3-6 months. Completed baseline QOL. Informed consent and agree to data and material transfer. Geographically accessible for f/u.

    Objectives: Primary: To determine the efficacy of adjuvant chemotherapy, in terms of disease-free survival, in women with radically resected loco-regional relapsed breast cancer. Secondary: To determine systemic disease-free and overall survival; sites of recurrence, incidence of second (non-breast) malignancies, and causes of death without relapse of breast cancer; and to determine the quality of life of patients treated with this regimen.

    NCT Registration ID (from clinicaltrials.gov): NCT00074152
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: February 11, 2005 Closing Date: November 30, 2007



    		Permanently Closed
    MA17L

    The Influence of Letrozole on Serum Lipid Concentrations in Women with Primary Breast Cancer Who Have Completed Five Years of Adjuvant Tamoxifen -- A Companion Study to MA.17


    The Influence of Letrozole on Serum Lipid Concentrations in Women with Primary Breast Cancer Who Have Completed Five Years of Adjuvant Tamoxifen -- A Companion Study to MA.17

    Eligibility: MA.17 patients, who are non-hyperlipidemic and not taking lipid lowering agents.

    Objectives: To evaluate the effects of letrozole on serum lipid parameters in post-menopausal women treated with letrozole or placebo following at least five years of adjuvant tamoxifen therapy for breast cancer.

    NCT Registration ID (from clinicaltrials.gov): no NCT
    Participation: Limited to MA.17 participants
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 09, 1999 Closing Date: May 02, 2002



    		Permanently Closed
    MAC9 (SWOG S0307)

    Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer


    Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer

    Complexity Level: 2

    Eligibility: Patients must be women with histologically confirmed primary invasive adenocarcinoma of the breast (Stage I, II, III) with no evidence of metastatic disease. Primary disease within the breast must be resected, either with mastectomy or breast sparing surgery. An axillary node evaluation should be performed per the standard of care specified at each institution.

    Objectives: To compare disease-free survival and overall survival of women with resected primary stage I-III adenocarcinoma of the breast treated with adjuvant zoledronate vs clodronate vs ibandronate. To compare the distributions of sites of first disease recurrence, adverse events and to correlate parathyroid hormone related protein status and N-telopeptide levels at baseline with disease-free survival and sites of first recurrence in patients with these drugs.

    NCT Registration ID (from clinicaltrials.gov): NCT00127205
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: July 24, 2006 Closing Date: February 01, 2010



    		Permanently Closed
    MA38 (MA38)

    Randomized Phase II Study Comparing Two Different Schedules of Palbociclib plus Second Line Endocrine Therapy in Women with Estrogen Receptor Positive, HER2 Negative Advanced/Metastatic Breast Cancer


    Randomized Phase II Study Comparing Two Different Schedules of Palbociclib plus Second Line Endocrine Therapy in Women with Estrogen Receptor Positive, HER2 Negative Advanced/Metastatic Breast Cancer

    Complexity Level: 2

    Eligibility: Adult women with locoregionally recurrent or metastatic disease not amenable to curative therapy. Confirmed diagnosis of ER positive breast cancer Postmenopausal status or pre/perimenopausal women suitable for ovarian suppressive therapy Progressed on prior endocrine therapy for advanced disease or within 12 months of adjuvant endocrine therapy Measurable disease as per Response Evaluation Criterion in Solid Tumors [RECIST] or bone-only disease Eastern Cooperative Oncology Group [ECOG] 0-2 Adequate organ and marrow function

    Objectives: Primary: Progression Free Survival Secondary: Adverse Events, Safety and Tolerability, Response Rate (in patients with measurable disease), Duration of Response, Clinical Benefit Rate, Overall Survival, Patient Reported Quality of Life using EORTC QLQC 30 and trial specific checklist, population PK/PD markers of drug effect in a subgroup of patients on both arms

    NCT Registration ID (from clinicaltrials.gov): NCT02630693
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: December 16, 2015 Closing Date: February 10, 2017



    		Permanently Closed
    MA32 (MA32)

    A Phase III Randomized Trial of Metformin versus Placebo on Recurrence and Survival in Early Stage Breast Cancer


    A Phase III Randomized Trial of Metformin versus Placebo on Recurrence and Survival in Early Stage Breast Cancer

    Complexity Level: 2

    Eligibility: Breast cancer T1C-3, NO-3, M0

    Objectives: Invasive disease free survival. Overall survival; distant disease-free survival; breast cancer free interval; invasive disease free survival in hormone receptor (ER and PgR) negative sub group; changes in body mass index; adverse events; other medical endpoints including a new diagnosis of diabetes mellitus or cardiovascular hospitalization or death (stroke, mycardial infarction); health related quality of life; correlative science outcomes; metabolic parameters and hospitalizations.

    NCT Registration ID (from clinicaltrials.gov): NCT01101438
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Permanently Closed
    Activation Date: June 25, 2010 Closing Date: January 22, 2013



    		Permanently Closed
    MA14

    A Randomized Trial of Antiestrogen Therapy versus Combined Antiestrogen and Octreotide Therapy in the Adjuvant Treatment of Breast Cancer in Post-Menopausal Women


    A Randomized Trial of Antiestrogen Therapy versus Combined Antiestrogen and Octreotide Therapy in the Adjuvant Treatment of Breast Cancer in Post-Menopausal Women

    NCT Registration ID (from clinicaltrials.gov): NCT00002864
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: September 24, 1996 Closing Date: July 21, 2000



    		Permanently Closed
    MA4

    National Cancer Institute Of Canada Cooperative Clinical Trial Of Adjuvant Post-Surgical Treatment Of Breast Carcinoma In Post-Menopausal Patients With Histologically Involved Axillary Nodes


    National Cancer Institute Of Canada Cooperative Clinical Trial Of Adjuvant Post-Surgical Treatment Of Breast Carcinoma In Post-Menopausal Patients With Histologically Involved Axillary Nodes

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: March 13, 1984 Closing Date: December 31, 1990



    		Permanently Closed
    MA31

    A Randomized, Open-Label, Phase III Study of Taxane Based Chemotherapy with Lapatinib or Trastuzumab as First-Line Therapy for Women with HER2/neu Positive Metastatic Breast Cancer


    A Randomized, Open-Label, Phase III Study of Taxane Based Chemotherapy with Lapatinib or Trastuzumab as First-Line Therapy for Women with HER2/neu Positive Metastatic Breast Cancer

    Complexity Level: 2

    Eligibility: Women with documented evidence of HER2/neu positive breast cancer (by local or central laboratory testing) which is metastatic, and with no prior chemotherapy and/or anti-HER2/neu targeted therapy in the metastatic setting.

    Objectives: Primary - Progression-Free Survival Secondary - Overall Survival - Time to CNS metastases at the time of progression - Incidence rates of CNS metastases at the time of progression - Overall objective response rate, time to response and duration of response - Clinical benefit response rate - Adverse event profile - Quality of Life (using the EORTC QLQ-C30 and a Trial Specific Checklist) - Clinical outcomes using biomarker changes in biological samples - Economic Evaluation: health utilities (using the EQ-5D questionnaire) and healthcare utilization

    NCT Registration ID (from clinicaltrials.gov): NCT00667251
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 17, 2008 Closing Date: December 01, 2011



    		Permanently Closed
    MA21 (MA21)

    A Phase III Adjuvant Trial of Sequenced EC + Filgrastim + Epoetin Alfa Followed by Paclitaxel Versus Sequenced AC Followed by Paclitaxel Versus CEF as Therapy for Premenopausal Women and Early Postmenopausal Women Who Have Had Potentially Curative Surgery for Node Positive or High Risk Node Negative Breast Cancer


    A Phase III Adjuvant Trial of Sequenced EC + Filgrastim + Epoetin Alfa Followed by Paclitaxel Versus Sequenced AC Followed by Paclitaxel Versus CEF as Therapy for Premenopausal Women and Early Postmenopausal Women Who Have Had Potentially Curative Surgery for Node Positive or High Risk Node Negative Breast Cancer

    Complexity Level: 2

    Eligibility: Women with histologically confirmed adenocarcinoma of the breast treated with either total or partial mastectomy; node positive or high risk node negative; T0-T4, N0, N1, or N2, M0; ER status must be known; < 60 years of age; no prior chemotherapy, hormonal therapy, immunotherapy or radiotherapy for breast cancer; adequate blood counts; ECOG < 2; LVEF > institutional lower normal limit; no history of cardiac disease.

    Objectives: To compare disease-free survival and overall survival among the three treatment arms. To compare rate of toxicities and quality of life among the three treatment arms.

    NCT Registration ID (from clinicaltrials.gov): NCT00014222
    Participation: Not Limited
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: December 04, 2000 Closing Date: April 29, 2005



    		Permanently Closed
    MAC2 (B-33)

    A Randomized, Placebo-Controlled, Double-Blind Trial Evaluating the Effect of Exemestane in Clinical Stage T1-3 N0-1 M0 Postmenopausal Breast Cancer Patients Completing at Least Five Years of Tamoxifen Therapy (NSABP: B-33).


    A Randomized, Placebo-Controlled, Double-Blind Trial Evaluating the Effect of Exemestane in Clinical Stage T1-3 N0-1 M0 Postmenopausal Breast Cancer Patients Completing at Least Five Years of Tamoxifen Therapy (NSABP: B-33).

    NCT Registration ID (from clinicaltrials.gov): NCT00016432
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: June 03, 2002 Closing Date: October 09, 2003



    		Permanently Closed
    MAC5 (IBCSG 25-02)

    A Phase III Trial Evaluating the Role of Exemestane Plus GnRH Analogue as Adjuvant Therapy for Premenopausal Women with Endocrine Responsive Breast Cancer


    A Phase III Trial Evaluating the Role of Exemestane Plus GnRH Analogue as Adjuvant Therapy for Premenopausal Women with Endocrine Responsive Breast Cancer

    Complexity Level: 2

    Eligibility: Premenopausal women with histologically proven, resected breast cancer with ER and/or PgR positive tumors. Patients should be randomized within 12 weeks after surgery prior to commencing any adjuvant systemic therapy.

    Objectives: This trial will evaluate the worth of ovarian function suppression (achieved by long-term use of GnRH analogue) plus exemestane compared with GnRH analogue plus tamoxifen for premenopausal women with steroid hormone receptor positive early invasive breast cancer. Patients may either receive no chemotherapy or commence chemotherapy at the same time that GnRH analogue is initiated

    NCT Registration ID (from clinicaltrials.gov): NCT00066703
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: October 07, 2003 Closing Date: March 11, 2011



    		Permanently Closed
    MA29 (MA29)

    A Feasibility Study of Pre-Operative Sunitinib (SU11248) With Multiple Pharmacodynamic Endpoints in Patients with T1c-T3 Operable Carcinoma of the Breast.


    A Feasibility Study of Pre-Operative Sunitinib (SU11248) With Multiple Pharmacodynamic Endpoints in Patients with T1c-T3 Operable Carcinoma of the Breast.

    Eligibility: Women with newly diagnosed, histopathologically confirmed, T1c, T2 or T3 unifocal, operable, carcinoma of the breast (prior to surgery).

    Objectives: PRIMARY: To assess the feasibility of administering oral sunitinib pre-operatively, to patients with newly diagnosed, histopathologically confirmed T1c, T2 or T3 unifocal, operable carcinoma of the breast. SECONDARY: - toxicity - tumour response (RECIST) - pharmacodynamic endpoints [treatment-induced changes (1) in the levels of tumour and plasma-soluble markers of angiogenesis, (2) in the protein/RNA levels of host and tumour-specific genes involved in response and toxicity to sunitinib, (3) on vascular parameters (DCE-MRI), (4) on cell death and tumour microcirculation (spectroscopic and microbubble contrast-enhanced ultrasound) and (5) on tumour metabolic activity (18-FDG-PET)] - tumour banking (optional)

    NCT Registration ID (from clinicaltrials.gov): NCT00482755
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: March 12, 2007 Closing Date: March 15, 2010



    		Permanently Closed
    MAC6 (26-02)

    A Phase III Trial Evaluating the Role of Chemotherapy as Adjuvant Therapy for Premenopausal Women with Endocrine Responsive Breast Cancer who Receive Endocrine Therapy


    A Phase III Trial Evaluating the Role of Chemotherapy as Adjuvant Therapy for Premenopausal Women with Endocrine Responsive Breast Cancer who Receive Endocrine Therapy

    Complexity Level: 2

    Eligibility: Premenopausal women with histologically proven, resected breast cancer with ER and/or PgR positive tumors for whom there is an uncertain role for adding chemotherapy to the adjuvant treatment program. Patients should be randomized within 12 weeks after surgery prior to commencing any adjuvant systemic therapy.

    Objectives: This trial will evaluate the worth of adding adjuvant chemotherapy for premenopausal women with steroid hormone receptor positive early invasive breast cancer who receive ovarian function suppression plus either tamoxifen or exemestane for five years. The use of chemotherapy will be determined by randomization. The method of ovarian function suppression (GnRH analogue for five years, surgical oophorectomy or ovarian irradiation) and the choice of tamoxifen or exemestane will be determined by the investigator.

    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: August 04, 2003 Closing Date: November 22, 2005



    		Permanently Closed
    MA10 (10921)

    A Multicentre Randomized Study of Dose-Intensive Chemotherapy as Primary Treatment in a Multimodality Approach for Locally Advanced/Inflammatory Breast Cancer (EORTC - NCIC CTG - SAKK Study)


    A Multicentre Randomized Study of Dose-Intensive Chemotherapy as Primary Treatment in a Multimodality Approach for Locally Advanced/Inflammatory Breast Cancer (EORTC - NCIC CTG - SAKK Study)

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: August 13, 1993 Closing Date: April 02, 1996



    		Permanently Closed
    MAC1 (CALGB 49907)

    A Randomized Trial of Adjuvant Chemotherapy With Standard Regimens, Cyclophosphamide, Methotrexate and Fluorouracil (CMF) or Doxorubicin and Cyclophosphamide - (AC), Versus Capecitabine in Women 65 Years and Older With Node Positive or Node-Negative Breast Cancer


    A Randomized Trial of Adjuvant Chemotherapy With Standard Regimens, Cyclophosphamide, Methotrexate and Fluorouracil (CMF) or Doxorubicin and Cyclophosphamide - (AC), Versus Capecitabine in Women 65 Years and Older With Node Positive or Node-Negative Breast Cancer

    Complexity Level: 2

    Eligibility: Patients with operable, histologically confirmed adenocarcinoma of the female breast. TNM Stage must be T1-3, N1, M0, or T, N0, M0 if a primary lesion is > 3 cm. Patients must be 65 years of age or older, with a performance status of 0 - 2. Patients may have received up to 4 weeks of tamoxifen therapy for this malignancy and still be eligible. Patients who received tamoxifen or raloxifene for purposes of chemoprevention or for other indications (including previous breast cancer) are eligible. Tamoxifen or raloxifene therapy should be discontinued before the patient is enrolled on this study.

    Objectives: To compare the effectiveness of standard chemotherapy regimens (CMF or AC) with single agent capecitabine with respect to disease-free survival in women 65 years of age and older with local and regional breast cancer. To compare the effectiveness of standard chemotherapy regimens with capecitabine with respect to overall survival. To determine the effects of each treatment regimen on quality of life and physical function. To assess the toxicity of each treatment regimen and to study the adherence to an oral chemotherapy regimen in older patients.

    NCT Registration ID (from clinicaltrials.gov): NCT00024102
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: May 28, 2002 Closing Date: December 29, 2006



    		Permanently Closed
    MA9 (8814)

    Phase III Comparison of Adjuvant Chemoendocrine Therapy with CAF and Concurrent or Delayed Tamoxifen to Tamoxifen Alone in Postmenopausal Patients with Involved Axillary Lymph Nodes and Positive Receptors


    Phase III Comparison of Adjuvant Chemoendocrine Therapy with CAF and Concurrent or Delayed Tamoxifen to Tamoxifen Alone in Postmenopausal Patients with Involved Axillary Lymph Nodes and Positive Receptors

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: November 21, 1991 Closing Date: July 31, 1995



    		Permanently Closed
    MA24 (BIG B016348)

    A Randomized Three-Arm Multi-Centre Comparison of 1 Year and 2 Years of Herceptin versus no Herceptin in Women With HER2-positive Primary Breast Cancer Who Have Completed Adjuvant Chemotherapy


    A Randomized Three-Arm Multi-Centre Comparison of 1 Year and 2 Years of Herceptin versus no Herceptin in Women With HER2-positive Primary Breast Cancer Who Have Completed Adjuvant Chemotherapy

    Complexity Level: 2

    Eligibility: Women with primary breast cancer that over-expresses HER2 (determined by IHC 3+ or FISH positive) who have completed (neo-) adjuvant systemic chemotherapy and radiotherapy, if applicable.

    Objectives: To compare disease-free survival (DFS) in patients with HER2 overexpressing breast cancer who have been randomized to Herceptin® for one year versus no Herceptin®. To compare DFS in patients with HER2 overexpressing breast cancer who have been randomized to Herceptin® for two years versus no Herceptin®.

    NCT Registration ID (from clinicaltrials.gov): NCT00045032
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: February 07, 2002 Closing Date: April 05, 2004



    		Permanently Closed
    MA26 (RTOG 9804)

    Phase III Trial of Observation +/- Tamoxifen Vs. Rt +/- Tamoxifen For Good Risk Duct Carcinoma In-Situ (DCIS) of The Female Breast


    Phase III Trial of Observation +/- Tamoxifen Vs. Rt +/- Tamoxifen For Good Risk Duct Carcinoma In-Situ (DCIS) of The Female Breast

    Complexity Level: 2

    Eligibility: Women > 26 years of age, with unicentric mammographically detected DCIS, < 2.5 cm in greatest dimension. Lesions must be classified as low or intermediate grade DCIS. Patients must be clinically node negative.

    Objectives: In the defined good-risk group, assess the role of whole breast radiation +/- tamoxifen compared to wide excision to negative margins alone +/- tamoxifen, in decreasing or delaying the appearance of local failure, both invasive and in-situ, and preventing the need for mastectomy. Assess distant disease free survival, adopt a working pathology classification system for DCIS, establish a registry for patients with an epidemiological questionnaire, and to establish a tissue bank of patients who progress to local failure in the study breast.

    NCT Registration ID (from clinicaltrials.gov): NCT00003857
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: January 09, 2002 Closing Date: July 14, 2006



    		Permanently Closed
    MAP3

    A Phase III Randomized Study of Exemestane Versus Placebo in Postmenopausal Women at Increased Risk of Developing Breast Cancer


    A Phase III Randomized Study of Exemestane Versus Placebo in Postmenopausal Women at Increased Risk of Developing Breast Cancer

    Complexity Level: 3

    Eligibility: Postmenopausal women at increased risk for the development of breast cancer are eligible for this study

    Objectives: To determine if exemestane reduces the incidence of invasive breast cancer compared with placebo

    NCT Registration ID (from clinicaltrials.gov): NCT00083174
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: February 11, 2004 Closing Date: March 23, 2010



    		Permanently Closed
    MAC13 (NCCTG N063D)

    Adjuvant, Lapatinib and/or Trastuzumab Treatment Optimisation Study A Randomised, Multi-Centre, Open-Label, Phase III Study of Adjuvant Lapatinib, Trastuzumab, Their Sequence and Their Combination in Patients with HER2/ErbB2 Positive Primary Breast Cancer


    Adjuvant, Lapatinib and/or Trastuzumab Treatment Optimisation Study A Randomised, Multi-Centre, Open-Label, Phase III Study of Adjuvant Lapatinib, Trastuzumab, Their Sequence and Their Combination in Patients with HER2/ErbB2 Positive Primary Breast Cancer

    Complexity Level: 2

    Eligibility: The target population for this trial are patients with non-metastatic, operable and over expression/amplification of HER2 (3+ by IHC and/or FISH positive) primary breast cancer. They must have completed definitive surgery and received prior systemic (neo-) adjuvant anthracycline-based chemotherapy for primary breast cancer. In cases for which a taxane is indicated, it should be given concomitantly with the targeted therapy and after anthracycline-based chemotherapy. For patients in whom docetaxel is indicated, it must be given prior to targeted therapy. Patients should not have received any prior anti-HER therapy, which includes agents that target other members of the HER family of receptors, e.g. gefitinib (Iressa).

    Objectives: Progression free survival

    NCT Registration ID (from clinicaltrials.gov): NCT00490139
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: July 10, 2008 Closing Date: August 31, 2011



    		Permanently Closed
    MA27B (MA.27B)

    The Influence of Five Years of Adjuvant Anastrozole or Exemestane on Bone Mineral Density in Postmenopausal Women with Primary Breast Cancer - A Companion Study to MA.27


    The Influence of Five Years of Adjuvant Anastrozole or Exemestane on Bone Mineral Density in Postmenopausal Women with Primary Breast Cancer - A Companion Study to MA.27

    Eligibility: MA.27 patients who have a bone mineral density measurement (using DEXA: dual energy x-ray absorptiometry) done within 12 weeks prior to randomization to the MA.27 core protocol may participate in the companion protocol. In order to be eligible patients must not have malabsorption syndrome, clinically relevant vitamin D deficiency, active hyper- or hypoparathyroidism, Paget's disease, uncontrolled thyroid disease, Cushing's disease, other pituitary diseases, or other bone diseases. Patients must not have received previous treatment with anticonvulsants or anabolic steroids within the past 12 months, high doses of corticosteroids or sodium fluoride for an extended time or be on long term treatment with coumarins

    Objectives: The primary objective is to examine whether there is a clinically relevant difference in impact on BMD between the steroidal (exemestane) and the non-steroidal (anastrozole) agents at 2 years

    NCT Registration ID (from clinicaltrials.gov): NCT00354302
    Participation: Limited to MA.27 participants
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 24, 2006 Closing Date: May 30, 2008



    		Permanently Closed
    MA16

    A Randomized Comparative Trial of High-Dose Chemotherapy and Autologous Stem Cell Support versus Standard Therapy Following Response to Anthracycline- or Taxane-Based Chemotherapy in Women With Metastatic Breast Cancer


    A Randomized Comparative Trial of High-Dose Chemotherapy and Autologous Stem Cell Support versus Standard Therapy Following Response to Anthracycline- or Taxane-Based Chemotherapy in Women With Metastatic Breast Cancer

    NCT Registration ID (from clinicaltrials.gov): NCT00003032
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 25, 1997 Closing Date: June 18, 2001



    		Permanently Closed
    MA22

    A Phase I/II Study of Increasing Doses of Epirubicin and Docetaxel Plus Pegfilgrastim for Locally Advanced Or Inflammatory Breast Cancer


    A Phase I/II Study of Increasing Doses of Epirubicin and Docetaxel Plus Pegfilgrastim for Locally Advanced Or Inflammatory Breast Cancer

    Complexity Level: 2

    Eligibility: To determine MTD and recommended phase II dose of docetaxel and epirubicin with pegfilgrastim in a phase I dose escalation study as 1st line therapy. To evaluate toxicity of the combination at the recommended phase II dose. To evaluate response rate and duration of the combination as first-line therapy at the recommended phase II dose.

    Objectives: Women with locally advanced or inflammatory breast cancer; no previous surgical systemic or radiation treatment for breast cancer other than biopsy for diagnosis; ECOG 0, 1, 2; adequate blood counts; LVEF > institutional lower normal limit; no history of cardiac disease.

    NCT Registration ID (from clinicaltrials.gov): NCT00066443
    Participation: Limited
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: February 25, 2003 Closing Date: June 08, 2009



    		Permanently Closed

    Gastro-intestinal

    IDStudy TitleStatus
    HE2

    SLIDE-HCC: Phase II trial of STRIDE (durvalumab + tremelimumab) + lenvatinib vs STRIDE in patients with unresectable hepatocellular carcinoma


    SLIDE-HCC: Phase II trial of STRIDE (durvalumab + tremelimumab) + lenvatinib vs STRIDE in patients with unresectable hepatocellular carcinoma

    Complexity Level: 2

    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Planned



    		Planned
    CO33

    A Phase III Trial of Botensilimab + Balstilimab or Botensilimab Alone versus Best Supportive Care as Therapy in Chemo-refractory, Advanced, Colorectal Adenocarcinoma: The BATTMAN Trial


    A Phase III Trial of Botensilimab + Balstilimab or Botensilimab Alone versus Best Supportive Care as Therapy in Chemo-refractory, Advanced, Colorectal Adenocarcinoma: The BATTMAN Trial

    Complexity Level: 2

    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: CCTG Led Trial
    Status: Planned



    		Planned
    PAC5 (SWOG S2408)

    A Randomized Phase III Multicentre Trial of Lanreotide for the Prevention of Postoperative Pancreatic Fistula


    A Randomized Phase III Multicentre Trial of Lanreotide for the Prevention of Postoperative Pancreatic Fistula

    Complexity Level: 2

    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Planned



    		Planned
    ES3 (NEEDS)

    NEoadjuvant chemoradiotherapy for Esophageal squamous cell carcinoma versus Definitive chemoradiotherapy with salvage Surgery as needed (NEEDS Trial)

    Assessing whether we can reduce the number of patients who require surgical intervention by limiting operations to only those who are found to need it following chemoradiotherapy.

    NEoadjuvant chemoradiotherapy for Esophageal squamous cell carcinoma versus Definitive chemoradiotherapy with salvage Surgery as needed (NEEDS Trial)

    Complexity Level: 2

    Eligibility: - Histopathologically confirmed SCC of the esophagus in locally advanced stages ct1 N+ or ct2-4a any N, M0 - Technically resectable disease Age >= 18 years and <=80 years - ECOG 0 - 1 - Adequate organ function - Women of childbearing potential must have a negative serum or urine pregnancy test

    Objectives: Primary - Overall survival (OS) with a minimum follow up of 2 years - Global health-related quality of life (HRQOL) one year after randomization Secondary - HRQOL - Event free survival (EFS) defined as time to relapse, initiation of any anti-tumor therapy beyond study treatments or death - Loco-regional and distant relapse rates - Histopathological response - Health economy - Surgical complications - Treatment-related adverse events and toxicity - Nutritional outcomes including weight development, dysphagia and appetite assessment - Gender stratified analyses of all endpoints - Exploratory analysis for putative tissue and liquid biomarkers for response to RCT and benefit from either of the two treatment strategies

    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Open to Accrual
    Activation Date: September 05, 2024



    		Open to Accrual
    GA4

    A Randomized Phase II Study of Paclitaxel and Ramucirumab +/- Zanidatamab in HER2 Positive Advanced Gastroesophageal Adenocarcinoma

    Participants with advanced stomach, gatroesophageal junction or esophageal cancer that is not treatable by surgical removal and which has high amounts of human epidermal growth factor receptor Type 2 (aka HER2) on the surface of their tumour cells, receive the anti-HER2 drug trastuzumab added to chemotherapy as standard of care, with the benefit that the addition of trastuzumab extends their survival. Investigation of other drugs that target HER2 and other cancer surface proteins simultaneously, or that link HER2 with another anti-cancer drug, have not shown benefit for these participants to-date. When these participants experience further growth of their cancer due to resistance, their next option for treatment is a combination of a toxic chemotherapy and a drug which binds to another cancer surface protein known as the vascular endothelial growth factor receptor type 2 (VEGFR2). Zanidatamab is a new type of antibody/drug that targets HER2, but offers the possible benefit over trastuzumab that it can not only bind slightly different versions of HER2, but it can also bind two HER2 receptors simultaneously. This means that zanidatamab may do a better, more efficient job of blocking HER2 receptors and may therefore have better effect in slowing tumour growth, or even causing tumour cell death. Early trials of zanidatamab in patients with stomach and esophageal cancers expressing HER2 have yielded very promising results both in terms of the effect on their cancers as well as the tolerability of zanidatamab. The current phase II study is seeking to determine whether there is sufficient early evidence that adding zanidatamab to the standard of care therapy for those participant who have become resistant to trastuzumab can better slow the growth of their tumours in order to proceed with a definitive, confirmatory phase III study which would be expected to lead to the approval of zanidatamab as standard of care treatment of these participants.

    A Randomized Phase II Study of Paclitaxel and Ramucirumab +/- Zanidatamab in HER2 Positive Advanced Gastroesophageal Adenocarcinoma

    Complexity Level: 2

    Eligibility: Patients must: Have histologically or pathologically confirmed gastroesophageal adenocarcinoma with HER2+ overexpression as confirmed by central testing using FDA-approved HER2 assay that is unresectable or metastatic. Have received and failed at lease one prior trastuzumab-containing regimen (combination with platinum chemotherapy) for treatment of metastatic disease. Failure is defined as demonstrated objective disease progression (radiologic). Have presence of measurable or evaluable disease as defined by Response Evaluation Criteria in Solid Tumours (RECIST 1.1). Have imaging investigations including CT/MRI of chest/abdomen/pelvis or other scans as necessary to document all sites of disease done within 28 days prior to randomization. ECOG performance status of 0 or 1. Have a life expectancy of > 12 weeks at the time of study entry. Adequate cardiac function by ECHO or MUGA defined as EF > 50% Have adequate normal organ and marrow function

    Objectives: Primary objective: Progression free survival Secondary objectives: Overall Survival, Objective Response Rate, Toxicity and Safety of Combination Therapy, Quality of Life, Identification and assessment of putative biomarkers of potential benefit in archival tumour specimens and baseline and on-treatment blood, serum and plasma samples, Other exploratory correlative analyses TBD

    NCT Registration ID (from clinicaltrials.gov): NCT06043427
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Open to Accrual
    Activation Date: November 22, 2023



    		Open to Accrual
    NE1 (NE.1)

    NET RETREAT: A Phase II Study of 177Lutetium- DOTATATE Retreatment vs. Everolimus in Metastatic/unresectable Midgut NET

    The purpose of this study is to find out whether retreatment with Peptide Receptor Radionuclide Therapy (PRRT) using Lutetium 177 dotatate can slow the growth of well-differentiated Grade 1 and Grade 2 metastatic midgut neuroendocine tumours compared to the usual approach of everollimus.

    NET RETREAT: A Phase II Study of 177Lutetium- DOTATATE Retreatment vs. Everolimus in Metastatic/unresectable Midgut NET

    Complexity Level: 2

    Eligibility: At least 18 years of age. Metastatic, histologically confirmed Grade 1 or 2 well-differentiated midgut NET with positive Gallium 68 DOTATATE or Copper 64 DOTATATE scan (SUVmax of target lesion is > SUV mean of normal liver parenchyma) within 36 months (within 12 months is preferred). Have received 3 or 4 cycles of PRRT. Have had progression per RECIST 1.1 after prior PRRT and no sooner than 12 months from last scan post initial PRRT completion where either stable disease, partial response, or complete response has been maintained. Have not received intervening therapy. No ongoing toxicity from prior PRRT that is Grade 3 or higher according to CTCAE 5.0. ECOG performance status
    Objectives: Primary Objective: Progression-free survival Secondary Objectives: toxicity and safety, overall response rate, overall survival, post progression survival and time to second objective disease progression for crossover patients, quality of life

    NCT Registration ID (from clinicaltrials.gov): NCT05773274
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Open to Accrual
    Activation Date: June 05, 2023



    		Open to Accrual
    CRC10 (NRG-GI008)

    Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease (CIRCULATE-NORTH AMERICA)

    We want to determine what kind of chemotherapy to recommend to patients based on the presence or absence of circulating tumor DNA (ctDNA) after srugery for colon cancer.

    Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease (CIRCULATE-NORTH AMERICA)

    Complexity Level: 2

    Eligibility: - Patient must be ≥ 18 years old. - Patients must have histologically/pathologically confirmed Stage IIB, IIC or Stage III colon adenocarcinoma with R0 resection accordingly to AJCC 8th edition criteria. - No radiographic evidence of overt metastatic disease within 28 days prior to study entry - The distal extent of the tumor must be ≥ 12 cm from the anal verge - The patient must have had an en bloc complete gross resection of tumor (curative resection). - The resected tumor specimen and a blood specimen from patients with Stage IIIA or Stage IIIB colon cancer must have central testing for ctDNA using the Signatera assay by Natera.

    Objectives: - To compare time to DFS event (recurrence, second primary colorectal cancer or death) in ctDNA (-ve) cohort following resection of stage III colon cancer treated with immediate vs delayed (based on serial ctDNA surveillance) chemotherapy. - compare time to DFS event (recurrence, second primary colorectal cancer or death) in ctDNA (+ve) cohort following resection of colon cancer treated with 5-FU (or capecitabine) and oxaliplatin x 6 months or 5-FU, oxaliplatin and irinotecan x 6 months.

    NCT Registration ID (from clinicaltrials.gov): NCT05174169
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Open to Accrual
    Activation Date: May 04, 2023



    		Open to Accrual
    PAC3 (ALLIANCE A021806)

    Perioperative versus Adjuvant Chemotherapy for Resectable Pancreatic Cancer

    The purpose of this study is to compare the usual treatment approach (surgery followed by chemotherapy) to using chemotherapy followed by surgery and then more chemotherapy. The addition of chemotherapy before surgery to the usual treatment approach could extend the life of patients, but it could also cause side effects. This study will help doctors find out if this different approach is better, the same, or worse than the usual approach. To decide if it is better, the doctors will be looking to see if the study approach increases the life of patients compared to the usual approach. This chemotherapy drug regimen, FOLFIRINOX, is already commonly used in pancreatic cancer. However, most of the time it is not used until after surgery.

    Perioperative versus Adjuvant Chemotherapy for Resectable Pancreatic Cancer

    Complexity Level: 2

    Eligibility: Histologic or cytologic proof of pancreatic adenocarcinoma or adenosquamous carcinoma, TNM Stage: Tx-4, N0-1, M0 Local radiographic reading consistent with resectable disease Confirmation of resectable disease by real-time central imaging review by the Alliance Imaging Core Lab at IROC Ohio Determined to be appropriate candidate for curative-intent pancreatectomy No prior radiation therapy, chemotherapy, targeted therapy, investigational therapy or surgery for pancreatic cancer Not pregnant and not nursing Age > or = to 18 years ECOG Performance Status 0-1 Total Neuropathy Score < 2 No known Gilbert's Syndrome or known homozygosity for UGATA1A1*28 polymorphism No comorbid conditions that would prohibit curative-intent pancreatectomy Chronic concomitant treatment with strong inhibitors and/or inducers of CYP3A4 is not allowed Measurable disease and/or non-measurable disease

    Objectives: The primary objective of this study is to evaluate and compare overall survival (OS) in patients with resectable pancreatic adenocarcinoma (PDAC) treated with perioperative mFOLFIRINOX and surgery versus up-front surgery followed by adjuvant mFOLFIRINOX.

    NCT Registration ID (from clinicaltrials.gov): NCT04340141
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Open to Accrual
    Activation Date: May 03, 2021



    		Open to Accrual
    CO32 (CO.32)

    A Phase 3 Randomized Trial Of Neoadjuvant Chemotherapy, Excision And Observation versus Chemoradiotherapy For Early Rectal Cancer. The NEO-RT Trial

    Testing chemotherapy versus chemotherapy plus radiotherapy prior to surgery for early rectal cancer

    A Phase 3 Randomized Trial Of Neoadjuvant Chemotherapy, Excision And Observation versus Chemoradiotherapy For Early Rectal Cancer. The NEO-RT Trial

    Complexity Level: 2

    Eligibility: - Histology confirmed invasive, well-moderately differentiated rectal adenocarcinoma, mismatch repair proficient. - MRI Stage cT1 or cT2 (not eligible for transanal surgery alone), cN0, M0 -Medically fit and eligible to undergo TME or TES - At least 18 yo, no contraindications for chemotherapy, adequate normal ogran and marrow function - ECOG 0 or 1 - Acceissble for treatment and follow up, and able and willing to complete QOL, and agree to use highly effective contraception methods (if applicable)

    Objectives: Primary Objective: - Compare the complete clinical response (cCR) rate and primary Quality of Life (QOL) endpoint defined as the rate of major low anterior resection syndrome (LARS) at 12 months after restaging between a strategy of induction chemotherapy and chemoradiotherapy followed by TES Secondary Objectives: - Compare TME free survival, DFS, rate of downstaging to ypT0/1N0/X, and toxicity between arms Tertiary Objectives: - correlative studies, RT planning technique outcomes

    NCT Registration ID (from clinicaltrials.gov): NCT06205485
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Open to Accrual
    Activation Date: February 29, 2024



    		Open to Accrual
    NE2 (AG0219NET)

    STOPNET - A Randomized Study of Cessation of Somatostatin Analogues after Peptide Receptor Radionuclide Therapy in Mid, Hind-Gut and Pancreatic Neuroendocrine Tumours

    A study of where SSAs are needed after PRRT therapy for patients with neuroendocrine tumours (STOPNET)

    STOPNET - A Randomized Study of Cessation of Somatostatin Analogues after Peptide Receptor Radionuclide Therapy in Mid, Hind-Gut and Pancreatic Neuroendocrine Tumours

    Complexity Level: 3

    Eligibility: MAIN INCLUSION CRITERIA: Adults over 18 years of age with well or moderately differentiated mid or hindgut neuroendocrine tumour, or pancreatic neuroendocrine tumour; Must have measurable disease; Patients who been receiving SSA for at least 3 months prior to study entry; Patients whose ancer has gotten worse after SSA treatment to warrant therapy with PRRT; PRRT is deemed the most appropriate next treatment step (i.e., patient is inoperable); ECOG PS 0-2 MAIN EXCLUSION CRITERIA: Gastric and lung NETs are excluded; Prior PRRT (patients being considered for re-treatment with PRRT are not eligible); Pregnancy

    Objectives: GENERAL AIM: To estimate the outcomes of patients with grade 1 and 2 pancreatic, mid and hind-gut neuroendocrine tumours who have progressed on SSA therapy and receive subsequent PRRT with or without concurrent SSA. CO-PRIMARY OBJECTIVES: - To estimate the 20-month progression free survival rate after PRRT in patients who cease and who continue SSA. - To assess the barriers which would impede the feasibility of a subsequent phase 3 trial: 1) Patient acceptance of ceasing and staying off SSA for the 20-month duration of the study follow up. 2) Ability to complete recruitment over the 24-month recruitment period. SECONDARY OBJECTIVES: - Measure QoL using EORTC QLQ-C30 and EORTC QLQ-GINET21 - Cost-effectiveness of SSA therapy cessation - Psycho-oncological impacts of SSA therapy cessation using the self-reported measures for Fear of Cancer Progression, Decisional Conflict and Decision Regret - Time to commencement of subsequent therapy - OS - Rates of SSA being recommended over time

    NCT Registration ID (from clinicaltrials.gov): NCT06345079
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Open to Accrual
    Activation Date: July 22, 2024



    		Open to Accrual
    PAC4 (ECOG-ACRIN EA2185)

    Comparing the Clinical Impact of Pancreatic Cyst Surveillance Programs


    Comparing the Clinical Impact of Pancreatic Cyst Surveillance Programs

    Complexity Level: 3

    Eligibility: Criteria: - Patients must be >/= 50 years and
    Objectives: To compare the rates of unfavorable clinical outcomes in the two arms. For clarity, favorable outcomes comprise: (1) High grade dysplasia (HGD) and/or resectable, early stage, pancreatic cancer (T1a, N0) at surgery; (2) benign disease and no surgery. However, the primary comparison between arms will be in terms of unfavorable outcomes.

    NCT Registration ID (from clinicaltrials.gov): NCT04239573
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: On Hold
    Activation Date: May 17, 2022



    		On Hold
    NEC3 (ALLIANCE A021202)

    Prospective Randomized Phase II Trial of Pazopanib (NSC# 737754, IND 75648) Versus Placebo in Patients with Progressive Carcinoid Tumors


    Prospective Randomized Phase II Trial of Pazopanib (NSC# 737754, IND 75648) Versus Placebo in Patients with Progressive Carcinoid Tumors

    Complexity Level: 2

    Eligibility: Patients with low or intermediate grade neuroendocrine carcinoma arising from the foregut, midgut, hindgut or other non-pancreatic site which is locally unresectable or metastatic. Must have measurable disease with radiological evidence of PD (may be either measure or non-measure PD). No prior treatment with an inhibitor of VEGF or VEGFR.

    Objectives: Primary Objectives: PFS Secondary Objectives: Objective tumour response rate (PR or CR); Overall survival (OS); Duration of Response (DR); Time to treatment failure (TTF) and Time to second progression for patients who crossover from placebo to active therapy.

    NCT Registration ID (from clinicaltrials.gov): NCT01841736
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: February 28, 2014 Closing Date: October 07, 2016



    		Closed to Accrual
    GA1 (TROG 0808)

    A Randomized Phase II/III Trial of Preoperative Chemoradiotherapy versus Preoperative Chemotherapy For Resectable Gastric Cancer (TOPGEAR)


    A Randomized Phase II/III Trial of Preoperative Chemoradiotherapy versus Preoperative Chemotherapy For Resectable Gastric Cancer (TOPGEAR)

    Complexity Level: 2

    Eligibility: Patients with resectable adenocarcinoma of stomach or gastroesophageal junction, Stage IB (T1N1) - IIIC (T3,4 and/or N+ve).

    Objectives: Primary: Overall Survival Secondary: DSF, toxicity, pCR rate, Surgical R0 Resection rate, , QoL; Economics; A biologic correlate

    NCT Registration ID (from clinicaltrials.gov): NCT01924819
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: July 31, 2013 Closing Date: July 01, 2021



    		Closed to Accrual
    PA7 (PA7)

    A Randomized Phase II Trial of Gemcitabine and Nab-Paclitaxel vs Gemcitabine, Nab-Paclitaxel, Durvalumab and Tremelimumab as 1st Line Therapy in Metastatic Pancreatic Adenocarcinoma


    A Randomized Phase II Trial of Gemcitabine and Nab-Paclitaxel vs Gemcitabine, Nab-Paclitaxel, Durvalumab and Tremelimumab as 1st Line Therapy in Metastatic Pancreatic Adenocarcinoma

    Complexity Level: 2

    Eligibility: Inclusion Criteria: Metastatic pancreatic ductal adenocarcinoma No prior treatment for metastatic disease May have received prior adjuvant Gemcitabine if longer then 6 months before recurrence Archival tissue available for correlative analysis ECOG PS 0,1 Exclusion Criteria: Medical contraindications to Gemcitabine or Nab-Paclitaxel Medical contraindications to MEDI 4736 (e.g. autoimmune disease)

    Objectives: Primary: - overall survival (OS) Secondary: -Progression Free Survival (PFS) - Toxicity and Safety - Objective Response Rate (ORR) Tertiary Endpoints: - Quality of Life (QoL) - Correlative Studies (PD-L1, hENT/SPARC,gene expression, ciruclating tumour DNA)

    NCT Registration ID (from clinicaltrials.gov): NCT02879318
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Closed to Accrual
    Activation Date: August 22, 2016 Closing Date: July 26, 2018



    		Closed to Accrual
    CO29 (AGITG CTDNA-08)

    Circulating Tumor DNA Analysis Informing Adjuvant Chemotherapy in Stage III Colon Cancer: A Multicentre Phase II/III Randomised Controlled Study (DYNAMIC III)


    Circulating Tumor DNA Analysis Informing Adjuvant Chemotherapy in Stage III Colon Cancer: A Multicentre Phase II/III Randomised Controlled Study (DYNAMIC III)

    Complexity Level: 2

    Eligibility: - Patients aged >=18 years of age - Subjects with curatively resected stage III (Any T, N1 or N2, M0) colorectal cancer - Patients with rectal cancer will be eligible unless they have had pre-operative combined chemotherapy and radiotherapy, or are scheduled for post-operative combined chemotherapy and radiotherapy. All rectal cancer patients must have had TME type surgery with negative (R0) resection margins. - A representative tumour sample is available for molecular testing up to 6 weeks after surgery (refer to section 9.1.1 for a more specific timeframe) - Fit for at least single agent fluoropyrimidine adjuvant chemotherapy - ECOG performance status 0-2 - No metastatic disease

    Objectives: Primary objective: To evaluate the impact of a de-escalation/escalation treatment strategy using ctDNA-informed management. The ctDNA positive and negative cohorts will be evaluated separately: (a) For ctDNA negative patients: de-escalation treatment strategy is non-inferior to standard of care (b) For the ctDNA positive patients: escalation treatment strategy is superior to standard of care. Secondary objectives: To demonstrate (1) ctDNA-informed adjuvant therapy approach will not compromise RFS in patients with NEGATIVE post-op ctDNA; (2) an acceptable rate of de-escalation in the ctDNA-informed negative cohort; (3) 3-year RFS rates between ctDNA-informed therapy and standard of care in patients with POSITIVE post-op ctDNA; (4) OS between ctDNA-informed therapy and standard of care in patients with POS & NEG post-op ctDNA; (5) end of treatment ctDNA results with RFS and OS; (6) feasibility of adjuvant chemo strategy based on post-op ctDNA results; (7) Heath economic impact

    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: February 09, 2021 Closing Date: March 31, 2023



    		Closed to Accrual
    CO27 (IROCAS)

    A Phase III, Randomised, International Trial Comparing mFOLFIRINOX Triplet Chemotherapy to mFOLFOX for high Risk Stage III Colon Cancer in Adjuvant Setting


    A Phase III, Randomised, International Trial Comparing mFOLFIRINOX Triplet Chemotherapy to mFOLFOX for high Risk Stage III Colon Cancer in Adjuvant Setting

    Complexity Level: 2

    Eligibility: Inclusion: Adults with pathologically confirmed high-risk stage III colon adenocarcinoma, who have undergone curative R0 surgical resection within 42 days before randomization. No prior abdominal/pelvic radiotherapy and no prior chemotherapy; adequate hematologic function; adequate liver function (bilirubin > 1.5 xUNL), Creatinine clearance > 50 mL/min; patient information and signed informed consent. Exclusions: Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start; metastatic disease; IBS; known hypersensitivity to any of study drugs; clinically relevant CAD or history of MI in last year or uncontrolled arrhythmia; previous malignancy; known DPD deficiency or UGTA1A1 homozygous 7/7.

    Objectives: Primary Objective: 3 year Disease Free Survival (DFS) Secondary Objectives: 2 year DFS, Overall Survival, safety of study treatment

    NCT Registration ID (from clinicaltrials.gov): NCT02967289
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: May 02, 2017 Closing Date: June 14, 2023



    		Closed to Accrual
    CRC9 (NRG-GI005)

    Phase II/III Study of Circulating tumOr DNA as a Predictive BiomarRker in Adjuvant Chemotherapy in Patients with Stage IIA Colon Cancer (COBRA)


    Phase II/III Study of Circulating tumOr DNA as a Predictive BiomarRker in Adjuvant Chemotherapy in Patients with Stage IIA Colon Cancer (COBRA)

    Complexity Level: 3

    Eligibility: Patients must 1) have histologically/pathologically confirmed stage 2A adenocarcinoma of colon with at least 12 LNs examined at resection 2) be appropriate for active surveillance 3) distal extent of tumor must be 12cm from the anal verge 4) complete gross tumor resection (curative resection) within 14-60 d of randomization 5) adequate tumor for testing 6) adequate hematologic-hepatic-renal function within 28 d before randomization 7) ECOG 0 or 1 8) only adenocarcinoma colon cancer histology 9) no metastatic disease 10) no tumor-related bowel perforation, history of prior invasive colon malignancy or organ transplantation 11) no prior systemic chemo, targeted therapy, IO, or RT for CRC 12) no other invasive malignancy & no antineoplastic therapy within 5 yrs before randomization 13) no uncontrolled cardiac disease 14) no sensory or motor neuropathy gr 2, active uncontrolled seizure disorder, active or chronic infection requiring systemic therapy, known homozygous DPD deficiency

    Objectives: PRIMARY OBJECTIVE (PH 2) - To compare the rate of ctDNA clearance in "ctDNA detected" patients treated with or without adjuvant chemotherapy following resection of stage IIA colon cancer PRIMARY OBJECTIVE (PH 3) - To compare RFS in "ctDNA detected" patients treated with or without adjuvant chemotherapy following resection of stage IIA colon cancer SECONDARY OBJECTIVES - in patients with stage IIA colon cancer: - To describe the prevalence of detectable ctDNA following surgical resection - To estimate time-to-event outcomes (OS, RFS, TTR) by ctDNA marker status & treatment - To estimate the rate of compliance with adjuvant chemotherapy &/or active surveillance EXPLORATORY OBJECTIVES: - To describe the association of quantitative ctDNA levels with time to event outcomes (RFS, OS, & TTR) - To characterize genomic profiles associated with recurrence using a ctDNA assay - To model the cost effectiveness of the use of ctDNA vs SOC in this setting

    NCT Registration ID (from clinicaltrials.gov): NCT04068103
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: April 21, 2020 Closing Date: February 15, 2024



    		Closed to Accrual
    GA3 (AGITG-AG0315OG)

    A Randomised Phase III Double-Blind Placebo-Controlled Study of Regorafenib in Refractory Advanced Gastro-Oesophageal Cancer (AGOC)


    A Randomised Phase III Double-Blind Placebo-Controlled Study of Regorafenib in Refractory Advanced Gastro-Oesophageal Cancer (AGOC)

    Complexity Level: 2

    Eligibility: Adults with histologically or cytologically confirmed advanced gastro-oesophageal Cancer (AGOC), with measurable metastatic or locally advanced disease, who have failed or were intolerant of 2 lines of prior anti-cancer therapy which have included a platinum & fluoropyrimidine analogue.

    Objectives: Primary Objective: OS in overall study population and in the Asian sub-population Secondary Objectives: PFS, Objective tumour response rate (PR or CR); Quality of life (QoL); Safety (rates of adverse events)

    NCT Registration ID (from clinicaltrials.gov): NCT02773524
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: January 09, 2017 Closing Date: February 03, 2021



    		Closed to Accrual
    CRC6 (CALGB C80702)

    A Phase III Trial of 6 versus 12 Treatments of Adjuvant Folfox Plus Celecoxib or Placebo For Patients With Resected Stage III Colon Cancer


    A Phase III Trial of 6 versus 12 Treatments of Adjuvant Folfox Plus Celecoxib or Placebo For Patients With Resected Stage III Colon Cancer

    Complexity Level: 2

    Eligibility: Histologically documented adenocarcinoma of the colon. The gross inferior (caudad) margin of the primary tumor must be at least 12 centimeters from the anal verge (i.e., patients with rectal cancer are not eligible).

    Objectives: To compare disease-free survival of patients with stage III colon cancer randomized to standard chemotherapy only (FOLFOX) or standard chemotherapy (FOLFOX) with 3 years of celecoxib 400 mg daily.

    NCT Registration ID (from clinicaltrials.gov): NCT01150045
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: March 28, 2011 Closing Date: November 20, 2015



    		Closed to Accrual
    CRC7 (ALLIANCE N1048)

    A Phase II/III Trial of Neoadjuvant FOLFOX, with Selective Use of Combined Modality Chemoradiation versus Preoperative Combined Modality Chemoradiation for Locally Advanced Rectal Cancer Patients Undergoing Low Anterior Resection with Total Mesorectal Excision (PROSPECT)


    A Phase II/III Trial of Neoadjuvant FOLFOX, with Selective Use of Combined Modality Chemoradiation versus Preoperative Combined Modality Chemoradiation for Locally Advanced Rectal Cancer Patients Undergoing Low Anterior Resection with Total Mesorectal Excision (PROSPECT)

    Complexity Level: 2

    Eligibility: Histologically confirmed clinical stage T2N1, T3N0, T3N1 (stage IIA, IIIA, or IIIB) adenocarcinoma of the rectum where standard treatment recommendation would be combined modality neoadjuvant chemoradiation followed by curative intent surgical resection

    Objectives: Primary Outcomes: Pelvic R0 resection rate (phase II) DFS (Phase III) Time to local recurrence (TLR)

    NCT Registration ID (from clinicaltrials.gov): NCT01515787
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: October 17, 2012 Closing Date: December 28, 2018



    		Closed to Accrual
    CRC8 (ECOG-ACRIN EA2165)

    A Randomized Phase III Study of Nivolumab after Combined Modality Therapy (CMT) in High-Risk Anal Cancer


    A Randomized Phase III Study of Nivolumab after Combined Modality Therapy (CMT) in High-Risk Anal Cancer

    Complexity Level: 2

    Eligibility: Registration step 1: Patients with histologically proven stage II (T3N0 only), IIIA, or IIIB invasive anal squamous cell carcinoma. For patients registering to Arm T, they must not have received prior chemoradiotherapy for anal cancer. Registration to step 2: Patients will be registered no sooner than 4 weeks following completion of standard chemoradiation for anal cancer (no less than 54 Gy). Patients must have histologically proven state II (T3N0 only), IIIA, or IIIB invasive anal squamous cell carcinoma.

    Objectives: Primary objective: To evaluate whether therapy with nivolumab following combined modality therapy (CMT) improves Disease-Free Survival (DFS) compared with observation in patients with high risk anal carcinoma. Secondary objectives: To compare nivolumab following combined modality therapy (CMT) with observation in patients with high risk anal carcinoma with ragard to objective response rate (complete CR and partial PR), stable disease and progression; severe toxicity interval; colostomy-free survival; overall survival; toxicity.

    NCT Registration ID (from clinicaltrials.gov): NCT03233711
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: August 16, 2018 Closing Date: August 24, 2021



    		Closed to Accrual
    CRC3 (ECOG E5202)

    A Randomized Phase III Study Comparing 5-FU, Leucovorin and Oxaliplatin versus 5-FU, Leucovorin, Oxaliplatin and Bevacizumab in Patients With Stage II Colon Cancer at High Risk for Recurrence to Determine Prospectively the Prognostic Value of Molecular Markers


    A Randomized Phase III Study Comparing 5-FU, Leucovorin and Oxaliplatin versus 5-FU, Leucovorin, Oxaliplatin and Bevacizumab in Patients With Stage II Colon Cancer at High Risk for Recurrence to Determine Prospectively the Prognostic Value of Molecular Markers

    Complexity Level: 2

    Eligibility: Patients must have histologically confirmed adenocarcinoma of the colon that meets the criteria below: Stage II carcinoma (T3,4 N0 M0): The tumor invades through the muscularis propria into the subserosa or into non-peritonealized pericolic or perirectal tissues (T3) or directly invades other organs or structures and/or perforates visceral peritoneum (T4). The distal extent of the tumor must be > 12 cm from the anal verge on endoscopy. If the patient is not a candidate for endoscopy, then the distal extent of the tumor must be > 12 cm from the anal verge as determined by surgical examination. Patients must have paraffin-embedded tumor specimen available for evaluation of microsatellite instability and loss of heterozygosity at 18q, to determine high risk versus low risk. Tumor samples and normal mucosa will be shipped as specified in Section 10.2. High-risk patients will be randomized to treatment Arms A or B. Low-risk patients will be registered to Arm C for observation.

    Objectives: Primary: To demonstrate an improvement in 3-year disease-free survival for high-risk stage II colon cancer patients randomly assigned to 5-FU, leucovorin, oxaliplatin versus 5-FU, leucovorin, oxaliplatin and bevacizumab. Secondary: To compare overall survival between the regimens.To further define the toxicity profiles of the regimens. To prospectively determine the impact of tumor biological characteristics on survival.

    NCT Registration ID (from clinicaltrials.gov): NCT00217737
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: April 27, 2006 Closing Date: February 11, 2011



    		Closed to Accrual
    CO21

    A Phase III Study of the Impact of a Physical Activity Program on Disease-Free Survival in Patients with High Risk Stage II or Stage III Colon Cancer: A Randomized Controlled Trial (CHALLENGE).


    A Phase III Study of the Impact of a Physical Activity Program on Disease-Free Survival in Patients with High Risk Stage II or Stage III Colon Cancer: A Randomized Controlled Trial (CHALLENGE).

    Complexity Level: 3

    Eligibility: Medically fit colon cancer patients (high risk stage II and stage III) who have completed adjuvant chemotherapy within the past 60-180 days. Current physical activity levels must not meet the recommended guidelines (>=150 minutes of moderate-to-vigorous or >=75 minutes of vigorous exercise/week). Following registration, and prior to randomization, patients must successfully complete at least two stages of a submaximal exercise test to ensure they are able to safely exercise at a moderate to vigorous intensity.

    Objectives: Primary Objective: Disease free survival (DFS) Secondary objectives: 1. To compare the two intervention arms with respect to: - Quality of Life (QOL) - Objective markers of physical fitness - Physical activity behaviour - Overall survival (OS) - Serum levels of insulin, IGF-1, IGF-2 and IGFBP3 - Cytokine levels - Economic evaluations including cost effective and cost-utility analyses - Predictors of physical activity adherence 2. To compare the following evaluations in all randomized patients to assess for potential associations - Molecular markers with DFS, OS, level of physical activity and level of fatigue - Age, gender, country, incremental increase in physical activity and change in aerobic fitness with DFS, OS, level of fatigue and QOL 3. To establish a comprehensive specimen bank linked to a clinical database for the further study of molecular markers in colon cancer

    NCT Registration ID (from clinicaltrials.gov): NCT00819208
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Closed to Accrual
    Activation Date: December 03, 2008 Closing Date: January 24, 2024



    		Closed to Accrual
    CO9PA (98-46-54)

    The Clinical and Pathologic Significance of Allelic Imbalance of 8p in Patients With Colorectal Cancer


    The Clinical and Pathologic Significance of Allelic Imbalance of 8p in Patients With Colorectal Cancer

    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: June 28, 2000 Closing Date: March 31, 2001



    		Permanently Closed
    CO20

    A Phase III Randomized Study of Brivanib Alaninate (BMS-582664) in Combination with Cetuximab (Erbitux) Versus Placebo in Combination with Cetuximab (Erbitux) in Patients With K-Ras Wild Type Tumours Previously Treated With Combination Chemotherapy for Metastatic Colorectal Carcinoma


    A Phase III Randomized Study of Brivanib Alaninate (BMS-582664) in Combination with Cetuximab (Erbitux) Versus Placebo in Combination with Cetuximab (Erbitux) in Patients With K-Ras Wild Type Tumours Previously Treated With Combination Chemotherapy for Metastatic Colorectal Carcinoma

    Complexity Level: 2

    Eligibility: Patients with pre-treated metastatic K-Ras wild type colorectal carcinoma.

    Objectives: Primary To compare overall survival Secondary To compare progression-free survival To compare the objective response rate To compare the duration of response To compare the quality of life in patients To compare health utilities To conduct a comparative economic evaluation To evaluate the safety profile of cetuximab administered weekly and brivanib/placebo taken daily To examine molecular markers Banking of tissue

    NCT Registration ID (from clinicaltrials.gov): NCT00640471
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: February 05, 2008 Closing Date: February 10, 2011



    		Permanently Closed
    CO7

    Phase III Clinical Trial of Chemotherapy with 5-Fluorouracil and L-leucovorin Following Potentially Curative Resection of Liver or Lung Metastases from Colorectal Cancer


    Phase III Clinical Trial of Chemotherapy with 5-Fluorouracil and L-leucovorin Following Potentially Curative Resection of Liver or Lung Metastases from Colorectal Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 15, 1994 Closing Date: January 23, 1998



    		Permanently Closed
    CO26

    A Phase II Randomized Study of Durvalumab and Tremelimumab and Best Supportive Care vs Best Supportive Care Alone in Patients with Advanced Colorectal Adenocarcinoma Refractory to Standard Therapies


    A Phase II Randomized Study of Durvalumab and Tremelimumab and Best Supportive Care vs Best Supportive Care Alone in Patients with Advanced Colorectal Adenocarcinoma Refractory to Standard Therapies

    Complexity Level: 2

    Eligibility: MAIN INCLUSION CRITERIA: Metastatic pre-treated colorectal cancer; Archival tissue available for correlative analysis; ECOG PS 0,1; Sufficient prior treatment with standard chemotherapy based regimens containing a fluoropyrimidine, irinotecan and oxaliplatin; Measurable or evaluable disease as per RECIST 1.1; MAIN EXCLUSION CRITERIA: Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab, or an anti-CTLA4, including tremelimumab; Medical contraindications to durvalumab (e.g. autoimmune disease); Prior immunotherapy or vaccines; Prior history of immunodeficiency; Prior use of immunosuppressive agents within 28 days, with the exception of corticosteroids (intranasal and inhaled) or systemic corticosteriods at physiological doses.

    Objectives: PRIMARY: Overall Survival SECONDARY: Progression Free Survival; assess toxicity and safety; Objective Response Rate TERTIARY: QoL; effect of tumour PD-L1 expression on efficacy; explore association between putative biomarkers (in archival tumour, blood, serum and plasma) and potential for clinical benefit

    NCT Registration ID (from clinicaltrials.gov): NCT02870920
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Permanently Closed
    Activation Date: August 10, 2016 Closing Date: June 29, 2017



    		Permanently Closed
    CRC2 (NCCTG N0147)

    A Randomized Phase III Trial of Oxaliplatin (OXAL) Plus 5-Fluouracil (5-FU)/Leucovorin (CF) with or without Cetuximab (C225) after Curative Resection for Patients with Stage III Colon Cancer


    A Randomized Phase III Trial of Oxaliplatin (OXAL) Plus 5-Fluouracil (5-FU)/Leucovorin (CF) with or without Cetuximab (C225) after Curative Resection for Patients with Stage III Colon Cancer

    Complexity Level: 2

    Eligibility: Histologically confirmed adenocarcinoma of the colon, Stage III disease. The gross inferior (caudad) margin of the primary tumor must be greater than or equal to 12 cm from the anal verge by rigid proctoscopy. Tumor must have been completely resected within past 56 days. At least one pathologically confirmed positive lymph node. No evidence of residual involved lymph node disease. No distant metastatic disease.

    Objectives: To compare disease-free survival of patients with curatively resected stage III colon cancer treated with adjuvant irinotecan vs oxaliplatin and fluorouracil and leucovorin calcium vs both regimens given consecutively (all irinotecan-containing treatment arms are closed to accrual as of 6/1/2005). To compare the disease-free survival of patients treated with these regimens with vs without cetuximab.

    NCT Registration ID (from clinicaltrials.gov): NCT00079274
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: September 22, 2004 Closing Date: November 25, 2009



    		Permanently Closed
    PAC2 (E4201)

    A Randomized Phase III Study of Gemcitabine in Combination With Radiation Therapy Versus Gemcitabine Alone in Patients With Localized, Unresectable Pancreatic Cancer.


    A Randomized Phase III Study of Gemcitabine in Combination With Radiation Therapy Versus Gemcitabine Alone in Patients With Localized, Unresectable Pancreatic Cancer.

    NCT Registration ID (from clinicaltrials.gov): NCT00057876
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: October 31, 2001 Closing Date: December 15, 2005



    		Permanently Closed
    BI1

    Phase III Trial of Combined Gemcitabine Plus Capecitabine Chemotherapy Versus Gemcitabine Alone in Advanced Biliary Cancer.


    Phase III Trial of Combined Gemcitabine Plus Capecitabine Chemotherapy Versus Gemcitabine Alone in Advanced Biliary Cancer.

    Eligibility: Patients with histologically/cytologically proven adenocarcinoma of the biliary tree (intra and extra-hepatic biliary ducts or gallbladder) that is either unresectable or metastatic. Patient must have evidence of disease but measurable disease is not required. They may not have received previous chemotherapy for advance or metastatic disease unless used as a radiosensitizer. Must have life expectancy > or = 12 weeks.

    Objectives: Primary: Overall survival. Secondary: Progression-free survival, response rates (CR and PR), rate of stable disease (SD), rate of disease control (CR, PR and SD), response duration, quality of life, toxicity

    NCT Registration ID (from clinicaltrials.gov): NCT00658593
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: March 19, 2008 Closing Date: July 14, 2009



    		Permanently Closed
    CO9 (914653)

    A Phase III Evaluation of High-Dose Levamisole Plus 5FU and Leucovorin as Surgical Adjuvant Therapy for High Risk Colon Cancer


    A Phase III Evaluation of High-Dose Levamisole Plus 5FU and Leucovorin as Surgical Adjuvant Therapy for High Risk Colon Cancer

    NCT Registration ID (from clinicaltrials.gov): NCT00003833
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: August 12, 1993 Closing Date: January 27, 1998



    		Permanently Closed
    CO23

    A Phase III Randomized Study of BBI608 and Best Supportive Care versus Placebo and Best Supportive Care in Patients with Pretreated Advanced Colorectal Carcinoma


    A Phase III Randomized Study of BBI608 and Best Supportive Care versus Placebo and Best Supportive Care in Patients with Pretreated Advanced Colorectal Carcinoma

    Complexity Level: 2

    Eligibility: Patients with pre-treated advanced colorectal carcinoma.

    Objectives: Primary Objective: -Overall Survival (OS) Secondary Objectives: -Progression-Free Survival (PFS) -Objective Response Rate (OR) -Disease Control Rate (DCR) -Safety profile -QoL, using the EORTC QLQ-C30 -HUI3, using the HUI3 index -Comparative economic evaluation -Exposure/response relationships of BBI608 using population PK -Association between putative biomarkers in tumour/blood & clinical benefit -Establish a comprehensive tumour bank linked to a clinical database

    NCT Registration ID (from clinicaltrials.gov): NCT01830621
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 15, 2013 Closing Date: May 23, 2014



    		Permanently Closed
    CRC5 (CALGB C80405)

    A Phase III Trial of Irinotecan/5-FU/Leucovorin or Oxaliplatin/5-FU/Leucovorin with Bevacizumab, or Cetuximab (C225), or with the Combination of Bevacizumab and Cetuximab for Patients with Untreated Metastatic Adenocarcinoma of the Colon or Rectum


    A Phase III Trial of Irinotecan/5-FU/Leucovorin or Oxaliplatin/5-FU/Leucovorin with Bevacizumab, or Cetuximab (C225), or with the Combination of Bevacizumab and Cetuximab for Patients with Untreated Metastatic Adenocarcinoma of the Colon or Rectum

    Complexity Level: 2

    Eligibility: Histologically confirmed locally advanced or metastatic and untreated adenocarcinoma of the colon or rectum.

    Objectives: To determine if the addition of cetuximab to FOLFIRI or FOLFOX chemotherapy with and without bevacizumab prolongs survival compared to FOLFIRI or FOLFOX with bevacizumab in patients with untreated, advanced ormetastatic colorectal cancer.

    NCT Registration ID (from clinicaltrials.gov): NCT00265850
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: March 03, 2008 Closing Date: March 01, 2012



    		Permanently Closed
    CO11 (9304)

    A Postoperative Evaluation of 5FU by Bolus Injection versus 5FU by Prolonged Venous Infusion Prior to and Following Combined Prolonged Venous Infusion + Pelvic XRT versus Bolus 5FU + Leucovorin + Levamisole Prior to and Following Combined Pelvic XRT + Bolus 5FU + Leucovorin in Patients With Rectal Cancer


    A Postoperative Evaluation of 5FU by Bolus Injection versus 5FU by Prolonged Venous Infusion Prior to and Following Combined Prolonged Venous Infusion + Pelvic XRT versus Bolus 5FU + Leucovorin + Levamisole Prior to and Following Combined Pelvic XRT + Bolus 5FU + Leucovorin in Patients With Rectal Cancer

    NCT Registration ID (from clinicaltrials.gov): NCT00002551
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: May 12, 1995 Closing Date: August 01, 2000



    		Permanently Closed
    CO14 (9581)

    Phase III Randomized Study of Adjuvant Immunotherapy with Monoclonal Antibody 17-1A Versus No Adjuvant Therapy Following Resection for Stage II (Modified Astler-Coller B2) Adenocarcinoma of the Colon


    Phase III Randomized Study of Adjuvant Immunotherapy with Monoclonal Antibody 17-1A Versus No Adjuvant Therapy Following Resection for Stage II (Modified Astler-Coller B2) Adenocarcinoma of the Colon

    Eligibility: Pathologically documented Stage II pT3N0 or pT4bN0 (Modified Astler-Coller B2) colon adenocarcinoma. Complete, en bloc resection of all of the primary tumour, performed as an open procedure and not laparoscopically or laparoscopically assisted. No evidence of perforation or clinical obstruction of the bowel. The gross distal margin of the primary tumour must lie above the peritoneal reflection (i.e. it must be a colon, not a rectal cancer). No previous radiation or chemotherapy for this malignancy. Age > 18 years. CALGB performance status 0 - 1. No current corticosteroid therapy for any reason. No prior exposure to murine antibodies. No uncontrolled or severe cardiovascular disease. No history of pancreatitis. Non-pregnant and non-lactating. No previous or concurrent malignancy.

    Objectives: To determine whether adjuvant treatment with MoAb 17-A will improve the probability of overall and disease-free survival, and increase disease-free intervals in patients who have undergone resection of a stage II (pT3N0 or pT4bN0) colon cancer. To evaluate a panel of prognostic markers, in order to correlate these measures with survival and recurrence after adjuvant therapy in patients who have undergone resection of a Stage II (pT3N0 or pT4bN0) colon cancer.

    NCT Registration ID (from clinicaltrials.gov): NCT00002968
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: October 12, 1999 Closing Date: May 31, 2002



    		Permanently Closed
    CO17 (CO17)

    A Phase III Randomized Study of Cetuximab (Erbitux TM, C225) and Best Supportive Care versus Best Supportive Care in Patients with Pretreated Metastatic Epidermal Growth Factor Receptor (EGFR) - Positive Colorectal Carcinoma


    A Phase III Randomized Study of Cetuximab (Erbitux TM, C225) and Best Supportive Care versus Best Supportive Care in Patients with Pretreated Metastatic Epidermal Growth Factor Receptor (EGFR) - Positive Colorectal Carcinoma

    Eligibility: Patients with pre-treated metastatic EGFR-positive colorectal carcinoma.

    Objectives: Primary To compare survival Secondary To compare the time to disease progression To compare the objective response rate To compare the quality of life in patients To conduct a comparative economic evaluation To evaluate the safety profile of cetuximab administered weekly

    NCT Registration ID (from clinicaltrials.gov): NCT00079066
    Participation: NCIC CTG and AGITG centres.
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 28, 2003 Closing Date: August 26, 2005



    		Permanently Closed
    GAC1 (CALGB C80101)

    Phase III Randomized Study of Adjuvant Chemoradiation After Resection in Patients with Gastric or Gastroesophageal Adenocarcinoma


    Phase III Randomized Study of Adjuvant Chemoradiation After Resection in Patients with Gastric or Gastroesophageal Adenocarcinoma

    Complexity Level: 2

    Eligibility: Patients must have histologically diagnosed adenocarcinoma of the stomach or gastroesophageal junction. Adenocarcinoma of the esophagus that are not involving the gastroesophageal junction are not eligible.

    Objectives: To determine whether overall survival is prolonged in patients with resected gastric adenocarcinoma who receive epirubicin, cisplatin and infusional 5-FU (ECF) before and after infusional 5-FU plus radiotherapy (RT) when compared to those treated with bolus 5-FU and leucovorin before and after infusional 5-FU plus RT.

    NCT Registration ID (from clinicaltrials.gov): NCT00052910
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: January 29, 2004 Closing Date: May 29, 2009



    		Permanently Closed
    CO16 (CR07)

    A Randomized Trial Comparing Pre-Operative Radiotherapy and Selective Post-Operative Chemoradiotherapy in Rectal Cancer.


    A Randomized Trial Comparing Pre-Operative Radiotherapy and Selective Post-Operative Chemoradiotherapy in Rectal Cancer.

    Complexity Level: 2

    Eligibility: Eligible patients have a histologically confirmed adenocarcinoma of the rectum (defined as lower edge of tumour within 15 cm of anal verge). The tumour must be considered potentially operable and patient must have no evidence of metastases.

    Objectives: The aim of this trial is to address the key question surrounding the use of radiotherapy in operable rectal cancer: Are local recurrence-free rates and quality of life optimized by giving all patients short course pre-operative radiotherapy, or is a preferable option to give post-operative chemoradiotherapy only to those at high risk of recurrence (i.e. with involved margins following surgery)?

    NCT Registration ID (from clinicaltrials.gov): NCT00003422
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: August 23, 2002 Closing Date: July 29, 2005



    		Permanently Closed
    GA2 (AGITG AG0212OG)

    INTEGRATE-A Randomized Phase II Double-Blind Placebo-Controlled Study of Regorafenib in Refractory Advanced Esophago-Gastric Cancer (AEGC)


    INTEGRATE-A Randomized Phase II Double-Blind Placebo-Controlled Study of Regorafenib in Refractory Advanced Esophago-Gastric Cancer (AEGC)

    Complexity Level: 2

    Eligibility: Adults with histologically or cytologically confirmed Esophago-gastric Cancer (EGC), with measurable metastatic or locally advanced disease, that is refractory to first or second line chemotherapy, or for whom second line chemotherapy is not appropriate.

    Objectives: Primary Objective: PFS Secondary Objectives: Objective tumour response rate (PR or CR); Clinical benefit at 2 months (CR or PR or SD); Overall survival (OS); PFS by Vascular Endothelial Growth Factor-A (VEGF-A) circulating levels (PD or Death by plasma VGEF: high vs low subgroups): Safety (rates of adverse events); Quality of life (QoL); all by arm to obtain reference values applicable to the control arm and design of a possible subsequent phase III trial. inform the design (e.g. sample size calculations) of any future phase III trial

    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: December 14, 2012 Closing Date: March 13, 2014



    		Permanently Closed
    HE1

    Phase III Study of Palliative Radiotherapy for Symptomatic Hepatocellular Carcinoma and Liver Metastases


    Phase III Study of Palliative Radiotherapy for Symptomatic Hepatocellular Carcinoma and Liver Metastases

    Complexity Level: 2

    Eligibility: Key eligibility criteria include diffuse, multifocal or locally advanced cancer involving the liver. Patients must be unsuitable for standard local, regional or systemic therapy, ECOG PS 0-3, Child Pugh not greater than C10, liver enzymes <10X ULN, and expected survival >3 months. In the 7 days prior to randomization, patients must have no significant change (range of 3 points is allowable) in pain score as measured over 2 days. All patients will receive best supportive care, and it is recommended that this include a palliative care or pain specialist assessment prior to randomization, when available.

    Objectives: The primary objective is to determine if patients with symptomatic liver tumours (either HCC or liver metastases) who undergo BSC plus a single 8 Gy fraction of radiation therapy to the liver experience a significant improvement in symptoms (defined as a >\= 2 point decrease in their pain "intensity at worst" score on the BPI) from baseline to 30 days as compared to patients receiving BSC alone. The secondary objectives are to compare the two treatment arms with respect to (1) proportion of patients experiencing grade >/= 2 adverse events at 30 days and 90 days, (2) proportion of patients alive at 90 days, (3) proportion of patients achieving improvement of liver cancer pain/discomfort by >\= 2 points from baseline to day 30 and day 90 in all BPI pain scores, (4) Proportion of patients reporting clinically significant improvement in QoL from bassline to day 30 and day 90, and (5) Proportion of patients achieving a 25% reduction in opioid use at 30 days.

    NCT Registration ID (from clinicaltrials.gov): NCT02511522
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: CCTG Led Trial
    Status: Permanently Closed
    Activation Date: July 23, 2015 Closing Date: June 06, 2022



    		Permanently Closed
    CO10

    A Phase III Study of Immediate Versus Delayed Chemotherapy for Asymptomatic Advanced Colorectal Cancer


    A Phase III Study of Immediate Versus Delayed Chemotherapy for Asymptomatic Advanced Colorectal Cancer

    NCT Registration ID (from clinicaltrials.gov): NCT00002570
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 15, 1994 Closing Date: March 31, 1999



    		Permanently Closed
    CO13 (N9741)

    A Randomized Phase III Trial of Combinations of Oxaliplatin (OXAL), 5-fluorouracil (5-FU), and Irinotecan (CPT-11) as Initial Treatment of Patients with Advanced Adenocarcinoma of the Colon and Rectum


    A Randomized Phase III Trial of Combinations of Oxaliplatin (OXAL), 5-fluorouracil (5-FU), and Irinotecan (CPT-11) as Initial Treatment of Patients with Advanced Adenocarcinoma of the Colon and Rectum

    Eligibility: Known locally advanced, locally recurrent or metastatic colorectal adenocarcinoma not curable by surgery or amenable to radiation therapy with curative intent or previously treated for advanced disease.

    Objectives: To compare the time to progression in patients with locally advanced or metastatic colorectal cancer (previously untreated for advanced disease) who receive OXAL + 5FU + CF or CPT-11 + OXAL (the two experimental regimens) to those receiving CPT-11 + 5-FU + CF (the control regimen). A secondary objective of this trial is to compare the time to progression of the patients receiving the two experimental regimens. Evaluation will be done of toxicity, response rate, time to treatment failure, survival, and quality-of-life parameters in patients on these regimens.

    NCT Registration ID (from clinicaltrials.gov): NCT00003594
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: November 16, 1999 Closing Date: July 19, 2002



    		Permanently Closed
    PA6 (UNICANCER ACCORD24)

    Multicentre Randomized Phase III Trial Comparing 6-Month Adjuvant Chemotherapy With Gemcitabine Versus 5-fluorouracil, Leucovorin, Irinotecan and Oxaliplatin (mFolfirinox) In Patients With Resected Pancreatic Adenocarcinoma


    Multicentre Randomized Phase III Trial Comparing 6-Month Adjuvant Chemotherapy With Gemcitabine Versus 5-fluorouracil, Leucovorin, Irinotecan and Oxaliplatin (mFolfirinox) In Patients With Resected Pancreatic Adenocarcinoma

    Complexity Level: 2

    Eligibility: Inclusion Criteria:- Histologically proven pancreatic ductal adenocarcinoma, Macroscopically complete resection (R0 or R1 resection), Patients aged from 18 to 79 years, Performance status 0-1, - No prior radiotherapy and no previous chemotherapy, No heart failure or coronary heart disease symptoms,Satisfactory postoperative recovery and patient able to receive chemotherapy,adequate oral nutrition of at least 1500 calories per day, free of significant nausea and vomiting,adequate hematologic function, Adequate liver function (bilirubin . 1.5 xUNL), Creatinine clearance > 50 mL/min, interval since the surgery between 21 and 84 days, patient information and signed informed consent. Exclusions: Non ductal adenocarcinoma of the pancreas (eg endocrine, acinar cell, cystadenocarcinoma and ampulloma), Metastases (including ascites or pleural malignant effusion), macroscopic incomplete tumour resection (R2), CA 19-9> 180u/ML within 21 day prior to randomization, concurrent/prior other cancer.

    Objectives: Primary: Disease-Free Survival Secondary: Overall Survival

    NCT Registration ID (from clinicaltrials.gov): NCT01526135
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: July 17, 2012 Closing Date: September 07, 2016



    		Permanently Closed
    PA3

    A Randomized Placebo Controlled Study of OSI-774 Plus Gemcitabine in Patients with Locally Advanced, Unresectable or Metastatic Pancreatic Cancer


    A Randomized Placebo Controlled Study of OSI-774 Plus Gemcitabine in Patients with Locally Advanced, Unresectable or Metastatic Pancreatic Cancer

    Eligibility: Patients with locally advanced, unresectable or metastatic adenocarcinoma of the pancreas who have received no prior chemotherapy other than 5FU (plus/ minus folinic acid) or gemcitabine given concurrently with radiation treatment as a radiosensitiser. Patients must have evidence of disease, but measureable disease is not mandatory.

    Objectives: The primary objective of the study is to compare the survival of patients in the two treatment groups, gemcitabine plus OSI-774 and gemcitabine plus placebo. Secondary objectives include comparison between the two groups of progression-free survival; quality of life; response rate; response duration; and toxicities. Further secondary objectives are to correlate the expression of tissue EGFR levels (at diagnosis) with outcomes and response to treatment, and to measure trough levels of OSI-774 to define population pharmacokinetics.

    NCT Registration ID (from clinicaltrials.gov): NCT00026338
    Participation: Initially limited to Canadian centres with IND Program experience; opened world-wide Mar 30, 2002.
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: October 29, 2001 Closing Date: January 31, 2003



    		Permanently Closed
    CO4

    Clinical Trial of Adjuvant 5FU/Folinic Acid in Rectal Cancer


    Clinical Trial of Adjuvant 5FU/Folinic Acid in Rectal Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 16, 1989 Closing Date: May 11, 1990



    		Permanently Closed
    CO12 (93-46-53)

    A Phase III Prospective Randomized Trial Comparing Laparoscopic-Assisted Colectomy Versus Open Colectomy for Colon Cancer


    A Phase III Prospective Randomized Trial Comparing Laparoscopic-Assisted Colectomy Versus Open Colectomy for Colon Cancer

    Eligibility: Patients must have the clinical diagnosis of adenocarcinoma involving a single colon segment of the right, left or sigmoid colon. Patient must not have prohibitive scars/ adhesions from previous abdominal surgery.

    Objectives: To test the hypothesis that disease-free survival and overall survival are equivalent, regardless of whether patients receive laparoscopic assisted colectomy or open colectomy. To determine the safety of laporoscopic assisted colectomy compared to open colectomy with respect to early and late morbidities and 30 day mortality.

    NCT Registration ID (from clinicaltrials.gov): NCT00002575
    Participation: Limited to pre-approved, designated surgeons at centres with current CPA #
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: November 27, 1996 Closing Date: August 31, 2001



    		Permanently Closed
    CO28

    NEOadjuvant Chemotherapy, Excision and Observation for Early Rectal Cancer: The NEO Trial


    NEOadjuvant Chemotherapy, Excision and Observation for Early Rectal Cancer: The NEO Trial

    Complexity Level: 2

    Eligibility: - Histologically confirmed invasive well-moderately differentiated rectal adenocarcinoma diagnosed within 90 days prior to enrollment. - Tumour stage cT1-T3abN0 based on pelvic MRI - cN0 stage based on pelvic MRI - No contraindications to protocol chemotherapy - M0 stage based on no evidence of metastatic disease by CT imaging - Mid to low-lying tumor eligible for local tumor excision in the opinion of the treating surgeon - Medically fit to undergo radical surgery as per treating surgeon's discretion - Patient does not have pathologic high risk factors on either/ or the initial biopsy specimen report or follow up biopsy (if done): high histologic grade, mucinous histology, lymphatic or vascular invasion

    Objectives: Protocol specified organ preservation rate

    NCT Registration ID (from clinicaltrials.gov): NCT03259035
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Permanently Closed
    Activation Date: August 22, 2017 Closing Date: May 19, 2020



    		Permanently Closed
    CO9SN (93-46-51)

    Evaluation of Serum Neopterin in Patients Receiving High-Dose Levamisole or Standard-Dose Levamisole in Combination with 5-FU (Fluorouracil) and Leucovorin as Surgical Adjuvant Therapy for High-Risk Colon Cancer. An NCCTG companion protocol to CO.9


    Evaluation of Serum Neopterin in Patients Receiving High-Dose Levamisole or Standard-Dose Levamisole in Combination with 5-FU (Fluorouracil) and Leucovorin as Surgical Adjuvant Therapy for High-Risk Colon Cancer. An NCCTG companion protocol to CO.9

    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: June 01, 1994 Closing Date: October 25, 1996



    		Permanently Closed
    CO2

    Systemic Infusion versus Bolus Chemotherapy With 5-Fluorouracil in Measurable Metastatic Colorectal Cancer


    Systemic Infusion versus Bolus Chemotherapy With 5-Fluorouracil in Measurable Metastatic Colorectal Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 31, 1986 Closing Date: January 31, 1989



    		Permanently Closed
    PA1

    A Phase III Study of Bay 12-9566 Versus Gemcitabine in Patients with Advanced or Metastatic Adenocarcinoma of the Pancreas


    A Phase III Study of Bay 12-9566 Versus Gemcitabine in Patients with Advanced or Metastatic Adenocarcinoma of the Pancreas

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: December 15, 1997 Closing Date: July 06, 1999



    		Permanently Closed
    CO1

    Protocol for a Clinical Trial of Carcinoma of the Colon and Rectum Utilizing Immunotherapy With and Without Chemotherapy as an Adjuvant to Surgery


    Protocol for a Clinical Trial of Carcinoma of the Colon and Rectum Utilizing Immunotherapy With and Without Chemotherapy as an Adjuvant to Surgery

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: November 01, 1978 Closing Date: September 01, 1981



    		Permanently Closed
    CRC4 (ECOG E5204)

    Intergroup Randomized Phase III Study of Postoperative Oxaliplatin, 5-Fluorouracil and Leucovorin vs Oxaliplatin, 5-Fluorouracil, Leucovorin and Bevacizumab for Patients with Stage II or III Rectal Cancer Receiving Pre-Operative Chemoradiation


    Intergroup Randomized Phase III Study of Postoperative Oxaliplatin, 5-Fluorouracil and Leucovorin vs Oxaliplatin, 5-Fluorouracil, Leucovorin and Bevacizumab for Patients with Stage II or III Rectal Cancer Receiving Pre-Operative Chemoradiation

    Complexity Level: 2

    Eligibility: Patients must have histologically-proven adenocarcinoma of the rectum with no distant metastases. Clinical (before neoadjuvant therapy) and pathologic staging are required. Patients with clinical stage T3N0M0, T4N0M0, TanyN1-2M0 are eligible. Patients must have received a minimum radiation dose of 40 Gy and not more than 55.8 Gy. Patients must have a completely resected tumor with no evidence of metastatic disease on the surgical/intra-operative examination and be between 28-56 days from the date of surgery

    Objectives: To compare the overall survival of patients with clinical Stage II and III rectal cancer who received preoperative chemoradiation and were treated with oxaliplatin leucovorin, 5-FU with or without bevacizumab postoperatively.

    NCT Registration ID (from clinicaltrials.gov): NCT00303628
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: December 12, 2006 Closing Date: April 29, 2009



    		Permanently Closed
    HEC1 (CALGB 80802)

    Phase III Randomized Study of Sorafenib Plus Doxorubicin versus Sorafenib in Patients with Advanced Hepatocellular Carcinoma (HCC)


    Phase III Randomized Study of Sorafenib Plus Doxorubicin versus Sorafenib in Patients with Advanced Hepatocellular Carcinoma (HCC)

    Complexity Level: 2

    Eligibility: Pathological or cytologically proven hepatocellular carcinoma. Locally advanced or metastatic disease. Patients must have measurable disease. No prior adjuvant therapy with sorafenib or other Raf/VEGFR inhibitors. No prior systemic tx for metastatic disease; Antiviral tx is allowed, but interferon therapy must be stopped >4 weeks prior to registration. Allografts are not allowed, including but not limited to liver and bone marrow transplants. No known CNS tumors including brain metastases. No significant GI bleeding events requiring intervention, transfusion, or admission to hospital within 30 days prior to study entry. > 4 weeks since major surgery. No rifampin or St. John's Wort; Hypertension must be well controlled. No known history of congestive heart failure > NYHA II or cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin. ECOG status 0-1

    Objectives: Primary: Compare overall survival (OS) of patients treated with sorafenib and doxorubicin to that of those treated with sorafenib. Secondary: Compare time to progression (TTP); Progression-free survival (PFS); Tumor response using RECIST.

    NCT Registration ID (from clinicaltrials.gov): NCT01015833
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: January 03, 2011 Closing Date: May 21, 2015



    		Permanently Closed
    PAC1 (S0205)

    A Phase III Randomized Open-Label Study Comparing Gemcitabine Plus Cetuximab (IMC-225) Versus Gemcitabine as First Line Therapy of Patients with Advanced Pancreas Cancer


    A Phase III Randomized Open-Label Study Comparing Gemcitabine Plus Cetuximab (IMC-225) Versus Gemcitabine as First Line Therapy of Patients with Advanced Pancreas Cancer

    Eligibility: Patients with advanced pancreatic cancer

    NCT Registration ID (from clinicaltrials.gov): NCT00075686
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: April 23, 2004 Closing Date: April 01, 2006



    		Permanently Closed
    CRC1 (E3200)

    A Phase III Trial of Bevacizumab (NSC 704865), Oxaliplatin (NSC 266046), Fluorouracil and Leucovorin versus Oxaliplatin, Fluorouracil and Leucovorin versus Bevacizumab Alone in Previously Treated Patients with Advanced Colorectal Cancer


    A Phase III Trial of Bevacizumab (NSC 704865), Oxaliplatin (NSC 266046), Fluorouracil and Leucovorin versus Oxaliplatin, Fluorouracil and Leucovorin versus Bevacizumab Alone in Previously Treated Patients with Advanced Colorectal Cancer

    NCT Registration ID (from clinicaltrials.gov): NCT00025337
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: January 10, 2003 Closing Date: April 28, 2003



    		Permanently Closed
    CO3

    Clinical Trial of Adjuvant Therapy With 5-Fluorouracil and Folinic Acid in Patients With Resectable Adenocarcinoma of the Colon


    Clinical Trial of Adjuvant Therapy With 5-Fluorouracil and Folinic Acid in Patients With Resectable Adenocarcinoma of the Colon

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: May 20, 1987 Closing Date: January 03, 1992



    		Permanently Closed
    CO5 (89-46-51)

    A Controlled Phase III Evaluation of 5fu Combined With Levamisole and Leucovorin as Adjuvant Treatment for Resectable Colon Cancer


    A Controlled Phase III Evaluation of 5fu Combined With Levamisole and Leucovorin as Adjuvant Treatment for Resectable Colon Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: March 16, 1990 Closing Date: October 11, 1991



    		Permanently Closed
    CO6 (9081)

    Intergroup Rectal Adjuvant Protocol: A Phase III Study


    Intergroup Rectal Adjuvant Protocol: A Phase III Study

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: January 04, 1991 Closing Date: November 22, 1992



    		Permanently Closed
    CO9QL

    Comparison of Quality of Life (QOL) in Patients Receiving High and Standard Dose Levamisole Plus 5-Fluorouracil and Leucovorin as Adjuvant Therapy for High-Risk Colon Cancer. A companion protocol to CO.9


    Comparison of Quality of Life (QOL) in Patients Receiving High and Standard Dose Levamisole Plus 5-Fluorouracil and Leucovorin as Adjuvant Therapy for High-Risk Colon Cancer. A companion protocol to CO.9

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: March 18, 1996 Closing Date: January 27, 1998



    		Permanently Closed
    CO15 (C89803)

    A Phase III Intergroup Trial of Irinotecan (CPT-11) (NSC #616348) Plus Fluorouracil/Leucovorin (5-FU/LV) Versus Fluorouracil / Leucovorin Alone After Curative Resection for Patients with Stage III Colon Cancer


    A Phase III Intergroup Trial of Irinotecan (CPT-11) (NSC #616348) Plus Fluorouracil/Leucovorin (5-FU/LV) Versus Fluorouracil / Leucovorin Alone After Curative Resection for Patients with Stage III Colon Cancer

    NCT Registration ID (from clinicaltrials.gov): NCT00003835
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: May 25, 2000 Closing Date: May 11, 2001



    		Permanently Closed
    CO8 (91-46-52)

    Phase III Study of Radiation Therapy, Levamisole and 5-Fluorouracil vs 5-Fluorouracil and Levamisole in Selected Patients With Completely Resected Colon Cancer.


    Phase III Study of Radiation Therapy, Levamisole and 5-Fluorouracil vs 5-Fluorouracil and Levamisole in Selected Patients With Completely Resected Colon Cancer.

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: September 03, 1993 Closing Date: December 17, 1996



    		Permanently Closed
    ES2 (TROG 03.01)

    A Randomized Phase III Study in Advanced Oesophageal Cancer To Compare Quality of Life and Palliation of Dysphagia In Patients Treated With Radiotherapy Versus Chemo-Radiotherapy.


    A Randomized Phase III Study in Advanced Oesophageal Cancer To Compare Quality of Life and Palliation of Dysphagia In Patients Treated With Radiotherapy Versus Chemo-Radiotherapy.

    Complexity Level: 2

    Eligibility: Patients with squamous cell or adenocarcinoma of the oesophagus who are deemed not suitable for definitive radical treatment due to the advanced nature of disease, presence of metastases or intercurrent illness, who have symptomatic dysphagia requiring loco-regional palliation.

    Objectives: To compare strategies to improve dysphagia in a simple fashion with minimal toxicity. To compare the toxicity of treatment with radiotherapy alone (RT) versus the same dose RT with added chemotherapy. To gain experience in the assessment of quality of life and improvement of dysphagia between the two regimens.

    NCT Registration ID (from clinicaltrials.gov): NCT00193882
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: October 27, 2003 Closing Date: March 21, 2012



    		Permanently Closed
    PA2 (ESPAC-3(V2))

    Phase III Adjuvant Trial In Pancreatic Cancer Comparing (1) 5FU And D-L Folinic Acid Vs (2) Gemcitabine Vs (3) No Adjuvant Treatment


    Phase III Adjuvant Trial In Pancreatic Cancer Comparing (1) 5FU And D-L Folinic Acid Vs (2) Gemcitabine Vs (3) No Adjuvant Treatment

    Complexity Level: 2

    Eligibility: Eligible patients have undergone complete macroscopic resection for ductal adenocarcinoma of the pancreas (R0 or R1 resection). Patients may also be included who have had complete macroscopic resection for ductal adenocarcinoma of the pancreas (R0 or R1 resection) and (R0 or R1 resection)for(i) unusual malignancies of the pancreas such as ascinar cell carcinoma, cystadenocarcinoma, etc.; (ii) cancers of the periampullary region; (iii) cancers of the intra-pancreatic part of the bile duct; (iv) periampullary cancers of uncertain origin.

    Objectives: This adjuvant study will test two hypotheses in a three arm study. A) Does either adjuvant gemcitabine or 5FU + folinic acid improve survival compared to no additional treatment following resection of pancreatic cancer. B) Is there any difference between gemcitabine and 5FU + folinic acid in terms of survival when used as adjuvant therapy following resection of pancreatic cancer. The primary endpoint is 2-year survival. Secondary endpoints will be toxicity, quality of life, and 5-year survival.

    NCT Registration ID (from clinicaltrials.gov): NCT00058201
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: October 31, 2001 Closing Date: May 06, 2008



    		Permanently Closed
    NEC2 (CALGB C80701)

    Randomized Phase II Study of Everolimus Alone versus Everolimus Plus Bevacizumab in Patients with Locally Advanced or Metastatic Pancreatic Neuroendocrine Tumours


    Randomized Phase II Study of Everolimus Alone versus Everolimus Plus Bevacizumab in Patients with Locally Advanced or Metastatic Pancreatic Neuroendocrine Tumours

    Complexity Level: 2

    Eligibility: Patients with Locally Advanced or Metastatic Pancreatic Neuroendocrine Tumours.

    Objectives: Primary: To assess the progression-free survival rate of patients with locally advanced or metastastic pancreatic neuroendocrine tumors treated with one of three novel regimens: bevacizumab alone, bevacizumab plus everolimus, or bevacizumab plus temozolomide. Secondary: Overall tumor response rate; overall biochemical response; toxicity; overall survival

    NCT Registration ID (from clinicaltrials.gov): NCT01229943
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: June 30, 2011 Closing Date: October 01, 2012



    		Permanently Closed

    Genito-urinary

    IDStudy TitleStatus
    PR26 (PR.26)

    TRIPLE-SWITCH: A Randomized Clinical Trial for the Addition of Docetaxel to Androgen Receptor Pathway Inhibitors in Patients with Metastatic Castration Sensitive Prostate Cancer Without Deep PSA Response


    TRIPLE-SWITCH: A Randomized Clinical Trial for the Addition of Docetaxel to Androgen Receptor Pathway Inhibitors in Patients with Metastatic Castration Sensitive Prostate Cancer Without Deep PSA Response

    Complexity Level: 2

    Eligibility: Histologically/cytologically confirmed adenocarcinoma of the prostate. Must have metastatic disease confirmed by conventional imaging (bone scan and/or computed tomography (CT) or by PET-PSMA scan only if CT component is of diagnostic quality. Patients must have received ADT for mCSPC for at least 6 months and no greater than 12 months at time of enrollment and ARPI (e.g. abiraterone acetate, enzalutamide, apalutamide, or darolutamide) for at least 4 months at time of enrollment. Must have PSA of ≥5.0 ng/ml (5.0 ug/L) prior to commencement of ADT. Must have serum testosterone < 1.7 nmol/L or 50 ng/dL. Patients must have adequate hepatic, renal, and bone marrow function. Patient must be male (assigned male at birth) ≥18 years of age.

    Objectives: PRIMARY: To compare overall survival (OS) in participants with mCSPC who are receiving standard of care ADT + ARPI and have suboptimal PSA response with those who receive standard of care ADT + ARPI plus docetaxel chemotherapy. SECONDARY: To compare both arms with respect to: (1) PSA progression (2) PSA response (3) PSA kinetics (4) Patient Reported Outcomes (5) Clinical progression free survival. TERTIARY: (1) To determine if detection and/or quantification of ctDNA can be a potentially useful biomarker for prognostication, prediction of docetaxel benefit (2) To explore OS by study arm using high- vs. low-volume mCSPC, ethnic or cultural origin, date of commencement of ADT, and molecular characterization of copy loss, inactivating mutations, structural rearrangements, and status of DNA-damage repair genes (3) To explore if social determinants of health impact quality of life outcomes.

    NCT Registration ID (from clinicaltrials.gov): NCT06592924
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Planned



    		Planned
    PR24 (PR.24)

    Androgen Suppression Combined with Elective Nodal Irradiation and Dose Escalated Prostate Treatment: A Non-Inferiority, Phase III Randomized Controlled Trial of Stereotactic Body Radiation Therapy versus Brachytherapy Boost in Patients with Unfavourable Risk Localized Prostate Cancer (ASCENDE-SBRT)

    The purpose of this study is to compare two types of radiation therapy to treat unfavourable-risk non-metastatic prostate cancer. This study is being done because we want to find out if hypofractionated radiation therapy (radiation given over a shorter period of time) using a high precision externally delivered technique known as SBRT is as effective in controlling prostate cancer as conventional external radiation therapy given with a brachytherapy boost (which involves radiation sources inserted directly into your prostate), and to know if it has fewer side effects and better quality-of-life.

    Androgen Suppression Combined with Elective Nodal Irradiation and Dose Escalated Prostate Treatment: A Non-Inferiority, Phase III Randomized Controlled Trial of Stereotactic Body Radiation Therapy versus Brachytherapy Boost in Patients with Unfavourable Risk Localized Prostate Cancer (ASCENDE-SBRT)

    Complexity Level: 2

    Eligibility: (1) Male, aged 18 years or older, (2) recent histologically confirmed prostate cancer with no evidence of metastases, (3) unfavourable-risk PC defined as NCCN unfavourable-intermediate risk, high risk and very-high risk, (4) ECOG PS 0-2, (5) medically suitable for all treatment options (including brachytherapy), (6) must be willing to take precautions to prevent pregnancy while on study. EXCLUSIONS: (1) Prior pelvic RT, (2) prior chemotherapy, PARPi, radioligand or other investigational drugs for prostate cancer, (3) contraindication to radical prostate RT, (4) anticoagulant medication and/or prior or current bleeding diathesis, (5) urinary function defined as IPSS > 20, (6) prior stem vaporization, TURP, prostatectomy (simple or radical), or any ablative therapy to the prostate, (7) prostate volume > 60cc before start of ADT, (8) evidence of castrate resistance (defined as a rising PSA > 3ng/ml while testosterone is <3.0nmol/l), (9) hip prostesis.

    Objectives: PRIMARY: To compare the progression-free survival (PFS) of SBRT versus brachytherapy boost defined as biochemical failure (PSA nadir + 2ng/ml), initiation of salvage therapy, biopsy-proven recurrent disease, metastasis diagnosed by conventional imaging , or death. SECONDARY: To evaluate both treatment strategies with respect to safety and tolerability, PSA response rate at 4 years, metastasis-free survival, cause-specific survival, overall survival, patient-reported outcomes, and economic outcomes. TERTIARY: To establish a comprehensive tumour bank linked to a clinical database for the further study of predictive and prognostic biomarkers in prostate cancer.

    NCT Registration ID (from clinicaltrials.gov): NCT06235697
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: CCTG Led Trial
    Status: Open to Accrual
    Activation Date: March 11, 2024



    		Open to Accrual
    BLC6 (ALLIANCE A032103)

    MODERN: An Integrated Phase 2/3 and Phase 3 Trial of MRD-Based Optimization of ADjuvant ThErapy in URothelial CaNcer

    Testing the role of DNA released from tumor cells into the blood in guiding the use of immunotherapy after surgical removal of the bladder for bladder cancer treatment.

    MODERN: An Integrated Phase 2/3 and Phase 3 Trial of MRD-Based Optimization of ADjuvant ThErapy in URothelial CaNcer

    Complexity Level: 2

    Eligibility: Pre-registration: • Histologically confirmed urothelial cancer of the bladder • Radical cystectomy ≥ 3 weeks, but ≤ 12 weeks prior to pre-registration • No evidence of residual cancer or metastases after surgery (imaging required prior to registration) • Available tumor tissue for “central” Signatera testing to be submitted after pre-registration • No active autoimmune disease or history of autoimmune disease that may recur • No current or history of pneumonitis or myocarditis • No known active Hepatitis B or C • No postoperative/adjuvant systemic therapy or radiation • No prior treatment with any PD-1 or PD-L1 axis inhibitors. • Age ≥18 years; Registration: • Radical cystectomy ≤ 18 weeks prior to registration. • ctDNA Signatera assay result based on test performed as part of “central testing” after pre-registration to A032103. • Disease-free status defined as no measurable disease by RECIST 1.1 within 60 days prior to registration

    Objectives: Co-primary objectives: 1) To compare the ctDNA clearance proportion [i.e., ctDNA (+) → ctDNA (-)] at 12 weeks in patients enrolled in Cohort A treated with adjuvant nivolumab versus nivolumab + relatlimab (phase 2 portion). 2) To compare overall survival in patients enrolled in Cohort A treated with adjuvant nivolumab versus nivolumab + relatlimab (phase 3 portion). 3) To compare disease-free survival in patients enrolled in Cohort B randomized to immediate treatment with nivolumab to those randomized to surveillance with subsequent treatment with nivolumab only upon converting to ctDNA(+)

    NCT Registration ID (from clinicaltrials.gov): NCT05987241
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Open to Accrual
    Activation Date: November 21, 2024



    		Open to Accrual
    PR25

    A Randomized Phase III Trial Investigating Platinum and Taxane Chemotherapy in Metastatic Castration Resistant Prostate Cancer Patients with Alterations in DNA Damage Response Genes (OPTION-DDR)

    The purpose of this trial is to determine the effect of adding carboplatin, a well-studied chemotherapy drug used to treat many kinds of cancer, to the standard treatment regimen of pariticpants with advanced prostate cancer who also have alterations in genes that help repair damaged DNA. Carboplatin is known to be effective in treating other cancer types with these mutations, and the researchers want to know if this applies to prostate cancer as well. The researchers also want to know if there are any alterations that can predict who would benefit from adding carboplatin. The toxicity of adding carboplatin will be evaluated as well.

    A Randomized Phase III Trial Investigating Platinum and Taxane Chemotherapy in Metastatic Castration Resistant Prostate Cancer Patients with Alterations in DNA Damage Response Genes (OPTION-DDR)

    Complexity Level: 2

    Eligibility: Men with a histological diagnosis of adenocarcinoma of the prostate with documented presence of metastatic disease. Participants must have received prior treatment with abiraterone, enzalutamide, apalutamide, or darolutamide, and have germline or somatic alterations in one or more of BRCA1, BRCA2, ATM, ATR, BRIP1, BARD1, CDK12, CHEK1, CHEK2, ERCC2, FANCA, FANCC, FANCD2, FANCL, PALB2, RAD51B, RAD51C, RAD51D, RAD54L. Medical or surgical castration is also required, along with a life expectancy greater than 12 weeks.

    Objectives: Primary: Overall survival. Secondary: Radiographic progression-free survival; PSA response; Objective soft tissue response; Frequency and severity of adverse events; Paticipant-reported QoL. Tertiary: Overall survival across ethnic groups; Overall survival across different DDR gene alterations; DDR gene alteration patterns across ethnic groups.

    NCT Registration ID (from clinicaltrials.gov): NCT06439225
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Open to Accrual
    Activation Date: October 08, 2024



    		Open to Accrual
    PR19

    A Randomized Phase II Trial Evaluating High Dose Rate Brachytherapy and Low Dose Rate Brachytherapy as Monotherapy in Localized Prostate Cancer

    The purpose of this study is to evaluate the dose of High Dose Rate (HDR) brachytherapy chosen for this study as well as a commonly used alternate form of brachytherapy called low dose rate (or seed) brachytherapy. Investigators would like to understand how these treatments control prostate cancer and look at their short and long term treatment related side effects.

    A Randomized Phase II Trial Evaluating High Dose Rate Brachytherapy and Low Dose Rate Brachytherapy as Monotherapy in Localized Prostate Cancer

    Complexity Level: 1

    Eligibility: Patients enrolled in this study must have histologically confirmed adenocarcinoma of the prostate diagnosed within the last 9 months and have low- (clinical stage T1-T2 and Gleason 6 and PSA <20 ng/mL) or intermediate-risk (clinical stage T1-T2 and Gleason 7 (3+4) and PSA < 15 ng/mL and < 50% of positive cores) prostate cancer.

    Objectives: Primary objective: prostate cancer control as defined by 48 month PSA values Secondary objectives: Disease-free survival, PSA progression, PSA nadir, local disease progression, regional disease progression, regional disease progression, distant disease progression, acute and long term toxicity and safety, Quality of Life (QOL) of the patient and their spouse/partner, resource utilization and economic indices of treatment administration. Tertiary objective: To establish a comprehensive tumour bank linked to a clinical database for the further study of predictive and prognostic biomarkers in prostate cancer.

    NCT Registration ID (from clinicaltrials.gov): NCT02960087
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: CCTG Led Trial
    Status: Open to Accrual
    Activation Date: November 04, 2016



    		Open to Accrual
    BLC4 (SWOG S1605)

    Phase II Trial of Atezolizumab in BCG-Unresponsive Non-muscle Invasive Bladder Cancer


    Phase II Trial of Atezolizumab in BCG-Unresponsive Non-muscle Invasive Bladder Cancer

    Complexity Level: 2

    Eligibility: Patients with histologically proven, recurrent, non-muscle invasive urothelial carcinoma of the bladder within 60 days prior to registration. The carcinoma must be Stage T1 High-Grade, Stage CIS, or Stage Ta High-Grade. Patients with mixed urothelial carcinoma and a glandular and/or squamous component will be eligible for the trial, but the presence of other histologic variants, pure adenocarcinoma, or pure squamous cell carcinoma, will make a patient ineligible. Patients must be deemed unfit for radical cystectomy by the treating physician, or the patient must refuse radical cystectomy, which is considered standard of carefor these patients. The reason for patients not to undergo cystectomy will be clearly documented.

    Objectives: Complete response at 25 weeks after registration for those with a CIS component; event-free survival at 18 months in patients with BCG-unresponsive high-risk non-muscle invasive bladder cancer (Ta/T1/CIS)treated with atezolizumab. To estimate event-free survival at 18 months for the subset of patients with papillary cancer (Ta/T1). Progression-free survival, cystectomy-free survival,bladder cancer specific survival, overall survival in all patients.

    NCT Registration ID (from clinicaltrials.gov): NCT02844816
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: April 07, 2017 Closing Date: July 05, 2019



    		Closed to Accrual
    BLC1 (SWOG S1011)

    A Phase III Surgical Trial to Evaluate the Benefit of a Standard versus an Extended Pelvic Lymphadenectomy Performed at the Time Of Radical Cystectomy For Muscle Invasive Urothelial Cancer


    A Phase III Surgical Trial to Evaluate the Benefit of a Standard versus an Extended Pelvic Lymphadenectomy Performed at the Time Of Radical Cystectomy For Muscle Invasive Urothelial Cancer

    Complexity Level: 2

    Eligibility: Patients must have histologically-proven (T2, T3, or T4a) urothelial carcinoma of the bladder (UCB) that requires primary radical cystectomy for definitive treatment.

    Objectives: Primary: To compare disease-free survival (DFS) in eligible patients treated with radical cystectomy and extended pelvic lymph node dissection (PLND) compared to radical cystectomy and standard pelvic lymphadenectomy. Secondary: To compare overall survival (OS) between extended PLND versus standard pelvic lymphadenectomy. To evaluate operative time, whether nerve sparing was performed, morbidity and mortality, length of hospital stay, histology, lymph node counts density, adjuvant chemotherapy, and local and retroperitoneal soft tissue recurrence. Proximal extent of node dissection in those patients randomized to extended PLND will be evaluated as well. Translational Medicine Objectives: a. To bank paraffin embedded blocks or slides of the primary tumor, b. To determine the prognostic value of putative markers of the premetastatic niche, c. To evaluate if the prevalence of pre-metastatic niche is different between patients that received neoadjuvant chemotherapy and those who did not.

    NCT Registration ID (from clinicaltrials.gov): NCT01224665
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: January 15, 2014 Closing Date: February 15, 2017



    		Closed to Accrual
    BL13F

    Electronic 'Real-Time' Patient Self-Reporting of Immunotherapy Symptomatic Adverse Events using the SYMPTOM-IQ Tool on the uMotif Mobile Health Application (APP): A Prospective Feasibility Sub-Study of BL13 [e-PRISM]


    Electronic 'Real-Time' Patient Self-Reporting of Immunotherapy Symptomatic Adverse Events using the SYMPTOM-IQ Tool on the uMotif Mobile Health Application (APP): A Prospective Feasibility Sub-Study of BL13 [e-PRISM]

    Complexity Level: 2

    Eligibility: Participants on both arms of the main BL.13 study are eligible for the BL.13F sub-study. Participants must be willing to complete symptom reports on a mobile phone application in English or French.

    Objectives: To assess feasibility (recruitment, retention, adherence) and acceptability of remote patient self-reporting of ten common symptomatic immune-related adverse events, using the uMotif mobile phone application.

    NCT Registration ID (from clinicaltrials.gov): no NCT
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: CCTG Led Trial
    Status: Closed to Accrual
    Activation Date: July 15, 2020 Closing Date: January 31, 2023



    		Closed to Accrual
    BL13

    A Randomized Phase II Trial Assessing Trimodality Therapy With or Without Adjuvant Durvalumab (MEDI4736) to Treat Patients with Muscle-Invasive Bladder Cancer


    A Randomized Phase II Trial Assessing Trimodality Therapy With or Without Adjuvant Durvalumab (MEDI4736) to Treat Patients with Muscle-Invasive Bladder Cancer

    Complexity Level: 2

    Eligibility: Histologic diagnosis of transitional cell carcinoma of the bladder with completion of prior trimodality therapy (surgery, chemotherapy and radiation) at least 42 days prior to study enrollment. Stage T2-T4a N0M0.

    Objectives: The overall objective of this phase II randomized trial is to determine if Durvalumab when used in combination following standard trimodality therapy improves disease-free-survival when compared to surveillance alone in patients with T2 or more muscle-invasive bladder cancer.

    NCT Registration ID (from clinicaltrials.gov): NCT03768570
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Closed to Accrual
    Activation Date: December 21, 2018 Closing Date: January 31, 2023



    		Closed to Accrual
    REC4 (ECOG-ACRIN EA8143)

    A Phase 3 RandOmized Study Comparing PERioperative Nivolumab vs. Observation in Patients with Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC)


    A Phase 3 RandOmized Study Comparing PERioperative Nivolumab vs. Observation in Patients with Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC)

    Complexity Level: 2

    Eligibility: Patients with newly diagnosed higher risk RCC of any histology including sarcomatoid or unknown histology confirmed by biopsy for which radical or partial nephrectomay is planned. Patients must have no distant metastases, history of RCC within the past 5 years and have had no concurrent or prior systemic or local anti-cancer therapy for RCC. Paitents must be over the age of 18 and have no active or suspected autoimmune disease, no ongoing condition requireing systemic treatment with corticosteroids/other immunosuppressants and no history of severe hypersensitivity to a monoclonal antibody.

    Objectives: Primary Objective: To compare recurrence-free survival (RFS) between patients with locally advanced renal cell carcinoma randomly assigned to perioperative nivolumab in conjunction with radical or partial nephrectomy with patients randomized to surgery alone. Secondary Objectives: To evaluate for differences in RFS associated with perioperative nivolumab compared to surgery alone among patients with clear cell histology. To compare the overall survival between the two arms. To describe the safety and tolerability of perioperative nivolumab.

    NCT Registration ID (from clinicaltrials.gov): NCT03055013
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: October 31, 2018 Closing Date: June 09, 2021



    		Closed to Accrual
    PRC4 (ALLIANCE A031201)

    Phase III Trial of Enzalutamide (NSC#766085) Versus Enzalutamide, Abiraterone and Prednisone for Castration Resistant Metastatic Prostate Cancer


    Phase III Trial of Enzalutamide (NSC#766085) Versus Enzalutamide, Abiraterone and Prednisone for Castration Resistant Metastatic Prostate Cancer

    Complexity Level: 2

    Eligibility: Progressive castration-resistant metastatic prostate cancer with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features.

    Objectives: To compare the overall survival of patients with progressive metastatic castration-resistant prostate cancer treated with either enzalutamide only or enzalutamide with abiraterone and prednisone. To assess the toxicity profile and compare safety by treatment arm, to assess and compare post-treatment PSA declines by treatment arm, to compare radiographic progression free survival and objective response rate by treatment arm, to test for radiographic progression free survival treatment interaction in predicting overall survival, to assess pre- and post-treatment measures of tumor burden and bone activity using PET/CT and bone scintigraphy and correlate these measures with overall survival, and to develop and validate prognostic and predictive models of overall survival.

    NCT Registration ID (from clinicaltrials.gov): NCT01949337
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: October 27, 2014 Closing Date: August 31, 2016



    		Closed to Accrual
    PRC3 (CALGB C90203)

    A Randomized Phase III Study of Neo-Adjuvant Docetaxel and Androgen Deprivation Prior to Radical Prostatectomy Versus Immediate Radical Prostatectomy in Patients with High-Risk, Clinically Localized Prostate Cancer.


    A Randomized Phase III Study of Neo-Adjuvant Docetaxel and Androgen Deprivation Prior to Radical Prostatectomy Versus Immediate Radical Prostatectomy in Patients with High-Risk, Clinically Localized Prostate Cancer.

    Complexity Level: 2

    Eligibility: Patients with High-Risk, Clinically Localized Prostate Cancer.

    Objectives: PSA Free Survival 3 Years Post Op; Compare 5-year bPFS, Disease Progresssion; Disease Free Survival and Overall Survival; Difference in Pathologic Stage; Safety and Tolerability; Correlative Studies: Diet and lifestyle; Frozen Tissue and Paraffin Blocks for Biomarker Analyses, Expression Profiling, chromosomal Gain or Loss Analysis

    NCT Registration ID (from clinicaltrials.gov): NCT00430183
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: October 15, 2007 Closing Date: October 02, 2015



    		Closed to Accrual
    PR17 (ANZUP 1304)

    Randomised Phase III Trial of Enzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer: ENZAMET


    Randomised Phase III Trial of Enzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer: ENZAMET

    Complexity Level: 2

    Eligibility: Men starting first line androgen deprivation therapy for metastatic adenocarcinoma of the prostate. Key eligibility criteria include metastatic prostate cancer, adequate organ function and ECOG performance status 0-2.

    Objectives: Primary endpoint: Overall survival

    NCT Registration ID (from clinicaltrials.gov): NCT02446405
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: February 02, 2015 Closing Date: March 24, 2017



    		Closed to Accrual
    PR20

    A Randomized Phase III Trial of Local Ablative Therapy For Hormone Sensitive Oligometastatic Prostate Cancer [PLATON]


    A Randomized Phase III Trial of Local Ablative Therapy For Hormone Sensitive Oligometastatic Prostate Cancer [PLATON]

    Complexity Level: 2

    Eligibility: (1) Male, aged 18 years or older, (2) Histologically-proven oligometstatic adenocarcinoma of the prostate and no evidence of small cell cancer,(3) Stage: IV (newly diagnosed at presentation or relapse after curative intent therapy); M1 dx less than/= to 5 mets; N1 disease can be included as site of metastases only in patients in relapse after curative intent prostate surgery or radiotherapy (4) Less than/= 3 mets in any non-bone organ system (5) All patients must receive Zoladex (LHRHa),(6)all tumours must be amenable to local ablative therapy (Radiation or surgery),(7) ECOG PS 0-1, (8)patient is medically suitable for all treatment options. EXCLUSION: prior adj/neoadj ADT, unless stopped >12 months & 36 mo. max duration; recurrent/metstatic disease previously treated with systemic or radiation therapy; Castration resistant prostate cancer (per PCWG3); Untreated pelvic lymph nodes as only site of disease; inability to treat all sites of disease with LAT; parenchymal brain mets.

    Objectives: Primary objective: To compare failure free survival between patients with oligometastatic HSPC treated with standard systemic therapy plus ablative therapy to untreated prostate primary in patients with low volume metastatic disease burden versus standard systemic therapy plus local ablative therapy to all sites of disease. Secondary objectives: Radiographic Progression Free Survival; Incidence of new metastases as first event; Overall survival; Ablative treatment related adverse events (grade 3 or greater); Quality of Life (QOL); Economic analysis. Tertiary objectives: Correlative exploratory studies such as immunophenotyping to understand mechanisms of resistance to SBRT when added to standard systemic therapy and identify predictive/prognostic markers in the trial population, and to create a biorepository of tissue and blood for future correlative studies.

    NCT Registration ID (from clinicaltrials.gov): NCT03784755
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: CCTG Led Trial
    Status: Closed to Accrual
    Activation Date: April 18, 2019 Closing Date: October 17, 2024



    		Closed to Accrual
    PR21

    A Randomized Phase II Study of 177Lu-PSMA-617 vs Docetaxel in Patients with Metastatic Castration-Resistant Prostate Cancer and PSMA-Positive Disease


    A Randomized Phase II Study of 177Lu-PSMA-617 vs Docetaxel in Patients with Metastatic Castration-Resistant Prostate Cancer and PSMA-Positive Disease

    Complexity Level: 2

    Eligibility: Inclusion: 1. Progression on treatment with abiraterone and/or enzalutamide, or similar next generation androgen receptor (AR) targeted therapy 2.Evidence of PSMA positive metastatic disease, as assessed on PSMA-ligand PET/CT or PSMA-ligand PET/MR 3. Biopsy-proven prostate cancer with no evidence of small cell component 4. Prior orchiectomy, or if on LHRH agonist/antagonist then testosterone 5. Patients must have castration resistance with prior evidence of biochemical or imaging progression in the setting of surgical/medical castration

    Objectives: (Primary): To compare radiographic progression-free survival (rPFS) of patients with metastatic castration-resistant prostate cancer (mCRPC) treated with 177Lu-PSMA radioligand therapy vs. docetaxel in the post androgen receptor (AR)-targeted therapy setting. (Secondary): Second rPFS in patients who meet criteria for rPFS and crossover to the alternate therapy (Secondary):Time to commencement of third line therapy (Secondary): Overall survival (Secondary):proportion of patients with decreased PSA from baseline and the magnitude of change (Secondary):Clinical benefit rate (CBR) and response duration including partial response (PR), complete response (CR) or stable disease > 24 weeks (Secondary): Determine adverse event (AE) profile (Secondary): Patient reported QOL (Secondary): Cost-effectiveness (Tertiary): explore biomarkers of response and resistance using cell free DNA (Tertiary): retrospectively explore a dosimetry-based approach to determine administered activity.

    NCT Registration ID (from clinicaltrials.gov): NCT04663997
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Closed to Accrual
    Activation Date: December 17, 2020 Closing Date: January 16, 2024



    		Closed to Accrual
    PR22 (ANZUP 1801)

    DASL-HiCaP: Darolutamide Augments Standard Therapy for Localized Very High-Risk Cancer of the Prostate. A Randomized Phase III Double-blind, Placebo-controlled Trial of Adding Darolutamide to Androgen Deprivation Therapy and Definitive or Salvage Radiation in Very High Risk, Clinically Localized Prostate Cancer


    DASL-HiCaP: Darolutamide Augments Standard Therapy for Localized Very High-Risk Cancer of the Prostate. A Randomized Phase III Double-blind, Placebo-controlled Trial of Adding Darolutamide to Androgen Deprivation Therapy and Definitive or Salvage Radiation in Very High Risk, Clinically Localized Prostate Cancer

    Complexity Level: 2

    Eligibility: Men with either very high-risk localized prostate cancer or very high-risk features with PSA persistence/rise within 12 months following radical prostatectomy, suitable for EBRT with or without brachytherapy. CT/MRI and bone scan negative for distant metastases (allow pelvic LN).

    Objectives: Primary: Metastasis-free survival Secondary: Overall survival; prostate cancer-specific survival; PSA-progression free survival; time to subsequent hormonal therapy; time to castration-resistance; frequency and severity of adverse events; health-related QoL; fear of cancer recurrence Tertiary: Incremental cost-effectiveness; prognostic/predictive biomarkers

    NCT Registration ID (from clinicaltrials.gov): NCT04136353
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: November 27, 2020 Closing Date: July 14, 2023



    		Closed to Accrual
    GCC1 (SWOG S1823)

    A Prospective Observational Cohort Study to Assess miRNA 371 for Outcome Prediction in Patients with Newly Diagnosed Germ Cell Tumours


    A Prospective Observational Cohort Study to Assess miRNA 371 for Outcome Prediction in Patients with Newly Diagnosed Germ Cell Tumours

    Complexity Level: 3

    Eligibility: Male or female patients must have a new diagnosis of a germ cell tumor. If surgery is planned, male patients with CSI Clinical Stage I testicular cancer must have orchiectomy completed within 42 days prior to registration. All primary sites, stages, histological subtypes of germ cell tumor and metachronous secondary germ cell tumors are eligible. Patients must be registered within 42 days after diagnosis and prior to initiation of a management plan or treatment for the disease. Additionally, within 42 days prior to registration, patients must: have initial imaging, laboratory and other clinical evaluations performed as defined in the protocol and have beta-human chorionic gonadotropin (beta- HCG), alpha-fetoprotein (AFP), and lactate dehydrogenase (LDH) assessments. Finally patients must: be >/= 18 years of age, have risk of relapse assessment determined by the local investigator prior to registration and agree to submit required specimens for defined translational medicine studies.

    Objectives: Primary Objective To estimate the positive predictive value within each of the early stage seminoma and non-seminoma groups using plasma miRNA 371 expression at relapse to detect germ cell malignancy. Secondary Objectives a. To bank prospectively obtained serial liquid biospecimens for low and moderate risk of relapse patients annotated by patient level clinical data. b. To bank prospectively collected, clinically annotated specimens for high risk patients and non-testicular primary patients in collaboration with Children's Oncology Group study AGCT 1531.

    NCT Registration ID (from clinicaltrials.gov): NCT04435756
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: August 27, 2020 Closing Date: May 20, 2024



    		Closed to Accrual
    BLC5 (ALLIANCE A032001)

    MAIN-CAV: Phase III Randomized Trials of Maintenance Cabozantinib and Avelumab vs Maintenance Avelumab After First-Line Platinum Based Chemotherapy in Patients with Metastatic Urothelial Cancer


    MAIN-CAV: Phase III Randomized Trials of Maintenance Cabozantinib and Avelumab vs Maintenance Avelumab After First-Line Platinum Based Chemotherapy in Patients with Metastatic Urothelial Cancer

    Complexity Level: 2

    Eligibility: - Histologically or cytologically-confirmed diagnosis of advanced or metastatic urothelial cancer of the renal pelvis, ureter, bladder, or urethra, including N3 only disease prior to start of first-line platinum-based chemotherapy. -Prior first-line treatment must have consisted of 4-6 cycles of 1st-line therapy. -No more than 1 line of prior chemotherapy for metastatic or locally advanced disease. -Tumor objective response of CR, PR, or SD upon completion of first line platinum-based chemotherapy. - The last dose of first-line chemotherapy must have been received no less than 3 weeks, and no more than 10 weeks, prior to randomization in the present study. -No prior immunotherapy with IL-2, IFN-?, or an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or CTLA-4 antibody (including ipilimumab), or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways. - 18 years or older. - ECOG Performance Status of 0 or 1.

    Objectives: Primary objective: To evaluate the effect of cabozantinib in combination with avelumab on OS compared to avelumab alone in patients with mUC who did not progress during first-line platinum-based chemotherapy therapy. Secondary Objectives: To evaluate progression-free survival (PFS), safety and tolerability and, activity of cabozantinib in combination with avelumab compared to avelumab alone. Quality of Life (QOL) Objectives: to compare quality of life measures using EQ-5D-5L, PROMIS-Figure4a, EORTC QLQ-C30, and EORTC-BLM30.

    NCT Registration ID (from clinicaltrials.gov): NCT05092958
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: October 04, 2022 Closing Date: March 20, 2024



    		Permanently Closed
    BL8 (30994)

    Randomized Phase III Trial Comparing Immediate Versus Deferred Chemotherapy After Radical Cystectomy in Patients with pT3-pT4, and/or N+M0 Transitional Cell Carcinoma (TCC) of the Bladder.


    Randomized Phase III Trial Comparing Immediate Versus Deferred Chemotherapy After Radical Cystectomy in Patients with pT3-pT4, and/or N+M0 Transitional Cell Carcinoma (TCC) of the Bladder.

    Complexity Level: 2

    Eligibility: Patients with histologically proven transitional cell carcinoma (TCC) of the bladder (pT2 incidental pT3 or pT4) and/or node positive (pN1-3) M0 TCC following radical cystectomy and lymphadenectomy. Lymph node dissection of 15 or more lymph nodes is recommended. Patients must be able to start chemotherapy within 90 days after surgery.

    Objectives: To compare the survival of patients with T3-T4 or N+ bladder cancer after radical cystectomy when treated with immediate adjuvant chemotherapy versus chemotherapy at relapse; to compare the progression-free survival.

    NCT Registration ID (from clinicaltrials.gov): NCT00028756
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: December 11, 2001 Closing Date: May 09, 2008



    		Permanently Closed
    PR10C (Z0071)

    Health-Related Quality of Life in Patients With Low Risk, Localized Prostate Cancer Randomized to Radical Prostatectomy or Brachytherapy


    Health-Related Quality of Life in Patients With Low Risk, Localized Prostate Cancer Randomized to Radical Prostatectomy or Brachytherapy

    Eligibility: Must be randomized to PR.10

    Objectives: To obtain quality of life information.

    NCT Registration ID (from clinicaltrials.gov): NCT00052481
    Participation: Patients randomized to PR.10
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: September 19, 2003 Closing Date: April 09, 2004



    		Permanently Closed
    BL12

    A Multicentre Randomized Phase II Trial Comparing Nab-Paclitaxel to Paclitaxel in Patients with Advanced Urothelial Cancer Progressing on or after a Platinum Containing Regimen


    A Multicentre Randomized Phase II Trial Comparing Nab-Paclitaxel to Paclitaxel in Patients with Advanced Urothelial Cancer Progressing on or after a Platinum Containing Regimen

    Complexity Level: 2

    Eligibility: Patients enrolled in this study must have histologically or cytologically confirmed diagnosis of transitional cell carcinoma of the urinary tract (bladder, urethra, ureter, renal pelvis) and metastatic or locally advanced inoperable disease extent (T4, N2, N3 or M1 disease).

    Objectives: Primary Objective: progression free survival (PFS) Secondary Objectives: objective response rates (ORR), clinical benefit rate (CBR), time to response and response duration, safety, QOL, and health analysis Exploratory Objectives: Correlative Biology, Health and Demographic Assessment

    NCT Registration ID (from clinicaltrials.gov): NCT02033993
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 27, 2014 Closing Date: April 06, 2017



    		Permanently Closed
    BL1

    A Clinical Trial on the Effects of Adjuvant Chemotherapy on Two Different Contemporary Treatments for Infiltrating Bladder Cancer


    A Clinical Trial on the Effects of Adjuvant Chemotherapy on Two Different Contemporary Treatments for Infiltrating Bladder Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 20, 1979 Closing Date: September 01, 1980



    		Permanently Closed
    BL10 (4B951)

    MVAC in Organ-Confined Bladder Cancer Based on p53 Status.


    MVAC in Organ-Confined Bladder Cancer Based on p53 Status.

    Eligibility: Patients who have undergone a radical cystectomy and bilateral pelvic lymphadenectomy

    Objectives: To compare the recurrence free and overall survival of those patients with alterations in the p53 gene who are treated with MVAC to patients with tumours demonstrating p53 alterations who are observed. To compare the recurrence free and overall survival prospectively of patients with tumours demonstrating alterations in p53 who are observed to patients with no p53 alterations who are also observed. To examine the expression of p53 and other genes, particularly RB, p21 and p16 involved in cell cycle regulation that may be involved in the response to chemotherapy. To study the association of p53 mutational gene status with p53 proteinexpression by IHC, outcome (recurrence-free and overall survival).

    NCT Registration ID (from clinicaltrials.gov): NCT00005047
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: December 22, 2003 Closing Date: March 28, 2006



    		Permanently Closed
    REC2 (ECOG E2805)

    ASSURE: Adjuvant Sorafenib or Sunitinib for Unfavorable Renal Carcinoma


    ASSURE: Adjuvant Sorafenib or Sunitinib for Unfavorable Renal Carcinoma

    Complexity Level: 2

    Eligibility: Patients with primary-intact renal cell carcinoma, eligible for nephrectomy with curative intent.

    Objectives: Primary: To demonstrate an improvement in disease-free survival in locally advanced renal cell carcinoma patients receiving Sunitinib vs Sorafenib vs placebo after radical or partial nephrectomy. Secondary: To compare overall survival of patients randomized to each of the two regimens with placebo, to further define toxicity of prolonged administration of study agents and to collect biological specimens to assess their characteristics and associations.

    NCT Registration ID (from clinicaltrials.gov): NCT00326898
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: September 14, 2006 Closing Date: September 02, 2010



    		Permanently Closed
    BL5 (BA06)

    A Phase III Study of Primary Chemotherapy in Locally Advanced Transitional Cell Carcinoma of the Bladder


    A Phase III Study of Primary Chemotherapy in Locally Advanced Transitional Cell Carcinoma of the Bladder

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: March 02, 1990 Closing Date: June 01, 1995



    		Permanently Closed
    PR6

    Randomized Placebo-Controlled Trial of Mitoxantrone/Prednisone and Clodronate versus Mitoxantrone/Prednisone Alone in Patients with Hormone Refractory Metastatic Prostate Cancer and Pain


    Randomized Placebo-Controlled Trial of Mitoxantrone/Prednisone and Clodronate versus Mitoxantrone/Prednisone Alone in Patients with Hormone Refractory Metastatic Prostate Cancer and Pain

    NCT Registration ID (from clinicaltrials.gov): NCT00003232
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: November 24, 1997 Closing Date: May 14, 2001



    		Permanently Closed
    PR3 (PR3)

    Intergroup Phase III Randomized Trial Comparing Total Androgen Blockade Versus Total Androgen Blockade Plus Pelvic Irradiation In Clinical Adenocarcinoma Of The Prostate


    Intergroup Phase III Randomized Trial Comparing Total Androgen Blockade Versus Total Androgen Blockade Plus Pelvic Irradiation In Clinical Adenocarcinoma Of The Prostate

    Eligibility: Patients with adenocarcinoma of the prostate who have performance status of 0-2, adequate blood counts and liver and kidney function, and no contraindication to pelvic radiotherapy.

    Objectives: To evaluate any benefit from the addition of radiation therapy to the treatment of the patients with cancer of the prostate who are receiving hormonal therapy in terms of overall survival, time to progression, symptomatic local control, and quality of life.

    NCT Registration ID (from clinicaltrials.gov): NCT00002633
    Participation: Limited to North America centres with current CPA/FWA#; all MRC - UK centres.
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: February 08, 1995 Closing Date: August 31, 2005



    		Permanently Closed
    PR12

    Phase III Study of Neoadjuvant Docetaxel And Androgen Suppression Plus Radiation Therapy Versus Androgen Suppression Alone Plus Radiation Therapy For High-Risk Localized Adenocarcinoma Of The Prostate (DART)


    Phase III Study of Neoadjuvant Docetaxel And Androgen Suppression Plus Radiation Therapy Versus Androgen Suppression Alone Plus Radiation Therapy For High-Risk Localized Adenocarcinoma Of The Prostate (DART)

    Eligibility: Patients with histologically proven, localized (NO, M0) adenocarcinoma of the prostate with adverse prognostic features which are considered to be high risk for recurrence based on the presence of at least one of the following features: T stage > or = to 3a, Gleason Score > or = 8 or presenting PSA>20

    Objectives: The primary objective is to compare disease free survival rates in men treated with androgen suppression therapy and radiation therapy followed by androgen suppression therapy with or without neoadjuvant docetaxel. Secondary objectives include overall survival, degree of PSA suppression prior to radiation therapy and Quality of Life.

    NCT Registration ID (from clinicaltrials.gov): NCT00651326
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: March 03, 2008 Closing Date: November 12, 2009



    		Permanently Closed
    PRC2 (CALGB C90202)

    A Randomized, Double-Blind, Placebo-Controlled Phase III Study of Early Versus Standard Zoledronic Acid to Prevent Skeletal Related Events in Men with Prostate Cancer Metastatic to Bone


    A Randomized, Double-Blind, Placebo-Controlled Phase III Study of Early Versus Standard Zoledronic Acid to Prevent Skeletal Related Events in Men with Prostate Cancer Metastatic to Bone

    Complexity Level: 2

    Eligibility: 1) Histologic documentation of prostate adenocarcinoma. 2) At least one bone metastasis by radiographic imaging 3) While on this study, patients must receive androgen deprivation therapy (ADT) for treatment of prostate cancer. 4) No prior treatment with bisphosphonates. 5) No prior treatment with radiation and hormones as specified in section 5.4 of the protocol. 6) ECOG (CTC) performance status 0-2. 7) Min. Age 18. 8) Baseline laboratory data should fall within protocol required limits.

    Objectives: Primary objective: To determine whether treatment with zoledronic acid at the time of initiation of androgen deprivation therapy for metastatic prostate cancer will delay the time to first skeletal related event. Secondary objective: To determine whether treatment with zoledronic acid will decrease the proportion of men with one or more vertebral fractures at two years compared to placebo in men receiving androgen deprivation therapy for metastatic prostate cancer.

    NCT Registration ID (from clinicaltrials.gov): NCT00079001
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: February 07, 2006 Closing Date: April 02, 2012



    		Permanently Closed
    PR2 (8794)

    Treatment of Pathologic Stage C Carcinoma of the Prostate With Adjuvant Radiotherapy


    Treatment of Pathologic Stage C Carcinoma of the Prostate With Adjuvant Radiotherapy

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: February 22, 1990 Closing Date: January 01, 1997



    		Permanently Closed
    PR13 (MRC PR10)

    RADICALS: Radiotherapy and Androgen Deprivation In Combination After Local Surgery


    RADICALS: Radiotherapy and Androgen Deprivation In Combination After Local Surgery

    Complexity Level: 2

    Eligibility: Men who have undergone radical prostatectomy for prostateic adenocarcinoma within 3 months. RT Timing Randomization: Post-opterative serum PSA less than 0.4 ng/mL. Uncertainty in the opinion of the physician and patient regarding the need for immediate post-operative RT. Hormone Duration Randomization: Post-opterative serum PSA less than 10 ng/mL. Patient is due to receive post-operative RT either adjuvant or salvage.

    Objectives: Disease free survival; Freedom from treatment failure; Clinical progression-free survival; Overall survival; Non-protocol hormone therapy Quality of life; Treatment toxicity

    NCT Registration ID (from clinicaltrials.gov): NCT00541047
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: September 27, 2007 Closing Date: December 30, 2016



    		Permanently Closed
    PR15

    Randomized Phase II Feasibility Trial Of Image Guided External Beam Radiotherapy With Or Without High Dose Rate Brachytherapy Boost In Men With Intermediate-Risk Prostate Cancer


    Randomized Phase II Feasibility Trial Of Image Guided External Beam Radiotherapy With Or Without High Dose Rate Brachytherapy Boost In Men With Intermediate-Risk Prostate Cancer

    Complexity Level: 1

    Eligibility: . Histologically confirmed CaP . PSA < 20 ng /ml . TNM classification . T2b to T2c, GS < 8/10 or . T1c-T2a GS 7/10 or . T1c-T2a, GS less than or equal to 6/10, 10 less than or equal to PSA < 20 . Prostate volume less than or equal to 75 cc

    Objectives: Primary: The primary objective of this feasibility study is to assess the ability of Canadian investigators from multiple institutions to randomize patients to curative intent IGRT or IGRT with HDR brachytherapy boost. Secondary: Acute GU and GI adverse events; Quality assurance; Treatment compliance

    NCT Registration ID (from clinicaltrials.gov): NCT01982786
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: November 05, 2013 Closing Date: September 30, 2015



    		Permanently Closed
    PRP1B

    An Investigation of Molecular and Genetic Risk Factors Associated With Development of Prostate Cancer in Subjects With High Grade Prostatic Intraepithelial Neoplasia Treated With Placebo or Combination Vitamin E, Selenium and Soy Protein Product


    An Investigation of Molecular and Genetic Risk Factors Associated With Development of Prostate Cancer in Subjects With High Grade Prostatic Intraepithelial Neoplasia Treated With Placebo or Combination Vitamin E, Selenium and Soy Protein Product

    Eligibility: Subjects who have met the eligibility criteria for and were previously enrolled in the NCIC CTG PRP.1 study: A double-blind, placebo-controlled, randomized study of combination vitamin E, selenium and soy protein product in subjects with high grade prostatic intraepithelial neoplasia.

    Objectives: To determine if molecular, genetic and immunohistochemical markers are associated with progression from high grade PIN to cancer. To determine if molecular or immunohistochemistry changes can occur in PIN among men treated with combination vitamin E, selenium and soy compared to placebo. To determine if cancers that arise within the PRP.1 study differ in terms of their proliferative capacity as measured by nuclear factor kappa B, p27 and ki-67, and to bank biopsy material, serum and DNA for future studies.

    NCT Registration ID (from clinicaltrials.gov): no NCT
    Participation: Limited to subjects enrolled on the PRP.1 study.
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 29, 2005 Closing Date: April 17, 2009



    		Permanently Closed
    BL11

    A Phase III Study of Iressa® in Combination with Intravesical BCG versus Intravesical BCG Alone in High Risk Superficial Transitional Cell Carcinoma of the Bladder


    A Phase III Study of Iressa® in Combination with Intravesical BCG versus Intravesical BCG Alone in High Risk Superficial Transitional Cell Carcinoma of the Bladder

    Eligibility: Patients with high risk Ta, Tis or T1 superficial bladder cancer, who completed transurethral resection of all visible bladder lesions within 21 to 60 days prior to randomization, and without other evidence of metastasis.

    Objectives: Comparisons of time to treatment failure, complete response rate for patients with carcinoma in situ (Tis) at randomization, time to recurrence, time to progression, overall survival, adverse event and safety, and quality of life. Evaluate prognostic significance of tumour marker expression on the primary tumour and impact of therapy on tumour marker expression.

    NCT Registration ID (from clinicaltrials.gov): NCT00352079
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 12, 2006 Closing Date: December 04, 2008



    		Permanently Closed
    BL3

    NCIC Trial of Pre-Operative (or Radical) Radiotherapy With Randomized Addition of Concurrent Cisplatin for Locally Advanced Transitional Cell Carcinoma of the Bladder


    NCIC Trial of Pre-Operative (or Radical) Radiotherapy With Randomized Addition of Concurrent Cisplatin for Locally Advanced Transitional Cell Carcinoma of the Bladder

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: May 03, 1985 Closing Date: April 19, 1989



    		Permanently Closed
    BL2

    The Prophylactic Use of Intravesical Mitomycin C in Recurrent Superficial Bladder Cancer


    The Prophylactic Use of Intravesical Mitomycin C in Recurrent Superficial Bladder Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: November 18, 1981 Closing Date: October 15, 1982



    		Permanently Closed
    BL4 (E5886)

    A Phase III Trial of Cisplan Alone or in Combination with Doxorubicin, Vinblastine and Methotrexate in Advanced Bladder Cancer


    A Phase III Trial of Cisplan Alone or in Combination with Doxorubicin, Vinblastine and Methotrexate in Advanced Bladder Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: October 30, 1986 Closing Date: May 15, 1989



    		Permanently Closed
    PR9 (P-0011)

    Phase III Clinical Trial for PT3 and/or Margin Positive Prostate Carcinoma Following Radical Prostatectomy


    Phase III Clinical Trial for PT3 and/or Margin Positive Prostate Carcinoma Following Radical Prostatectomy

    Eligibility: Patients will have pathologic stage T3N0M0 prostate cancer at high-risk for PSA relapse as determined by GS > 7 and one or more of the following: 1) preoperative PSA > 10 ng/ml; 2) positive surgical margins; 3) seminal vesicle invasion. If Gleason score < 7, then two or more of the above factors. Patients who have negative LN status by lymph node sampling or LN dissection will be eligible. If pathologic LN status is unknown, the risk of involvement must be less than 5 % as determined by the Roach formula.

    Objectives: To test, in a randomized study, if the addition of androgen suppression to radiation therapy in patients with unfavorable pathologic stage pT3N0M0 prostate cancer leads to better outcome than each used separately. The endpoints will be overall survival, disease-free survival, freedom from distant metastases, and freedom from PSA failure. To compare the qualitative and quantitative toxicities of patients with pT3N0M0 prostate cancer treated adjuvantly with androgen suppression and radiation therapy to that of adjuvant radiation therapy or androgen suppression alone.

    NCT Registration ID (from clinicaltrials.gov): NCT00023829
    Participation: Limited to centres with a current CPA/FWA #
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: February 25, 2004 Closing Date: May 07, 2004



    		Permanently Closed
    PR1

    Hormonal Therapy versus Radiotherapy for the Treatment of Clinical Stage C and D Carcinoma of the Prostate


    Hormonal Therapy versus Radiotherapy for the Treatment of Clinical Stage C and D Carcinoma of the Prostate

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 01, 1979 Closing Date: May 26, 1981



    		Permanently Closed
    PNC1 (ECOG-ACRIN EA8134)

    InPACT: International Penile Advanced Cancer Trial


    InPACT: International Penile Advanced Cancer Trial

    Complexity Level: 2

    Eligibility: (1) Male, aged 18 years or older, (2) Histologically-proven squamous cell carcinoma of the penis. (3) Stage: any T, N1 (i.e. a palpable mobile unilateral inguinal lymph node), M0, OR; any T, N2 (i.e. palpable mobile multiple or bilateral inguinal lymph nodes), M0 OR; any T, N3 (i.e. fixed inguinal nodal mass or any pelvic lymphadenopathy), M0, (4) Measurable disease as determined by RECIST (version 1.1) criteria, (5)Performance Status ECOG 0, 1 or 2, (6) Patient is fit to receive the randomisation options for which he is being considered. (7) adequate hematology, biochemistry, liver function, renal function tests, and patient must be suitable for randomization options. EXCLUSION: Pure verrucous carcinoma of the penis; Non-squamous malignancy of the penis; Squamous carcinoma of the urethra; Stage M1; Previous chemotherapy or chemoradiotherapy outside of the InPACT trial.

    Objectives: Primary objective: (1) (a) Is there a role for neoadjuvant therapy and, if so, (b) does CT or CRT produce superior outcomes (2) What is the additional survival benefit of PLND given after neoadjuvant s or with adjuvant CRT of the pelvic nodes over and above that of chemoradiotherapy alone in patients at high risk of recurrence following ILND? Secondary objectives: In InPACT-neoadjuvant: (a) Can neoadjuvant therapy prior to surgery (ILND) reduce recurrence rates? (b) Which is the more active of neoadjuvant CT or neoadjuvant CRT? (c) What is the op/post-op complication rate following neoadjuvant therapy of both types? (c) Is neoadjuvant CRT feasible in this setting? In InPACT-pelvis: (a) What is the rate of additional complications for the combination of PLND and CRT? Exploratory objectives: (a) What is the relationship between HPV status and outcome for all groups studied? (b) What is the impact on QOL of (sequential) treatments studied?

    NCT Registration ID (from clinicaltrials.gov): NCT02305654
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: May 30, 2018 Closing Date: December 02, 2022



    		Permanently Closed
    REC1 (CALGB C90206)

    A Phase III Trial of Interferon-Alpha (IFNA) or IFNA Plus Bevacizumab in Advanced Renal Cell Cancer


    A Phase III Trial of Interferon-Alpha (IFNA) or IFNA Plus Bevacizumab in Advanced Renal Cell Cancer

    Complexity Level: 2

    Eligibility: Patients with advanced renal cell cancer.

    NCT Registration ID (from clinicaltrials.gov): NCT00072046
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: April 23, 2004 Closing Date: July 01, 2005



    		Permanently Closed
    PRP1

    A Double-Blind, Placebo-Controlled, Randomized Study of Combination Vitamin E, Selenium and Soy Protein Product in Subjects With High Grade Prostatic Intraepithelial Neoplasia


    A Double-Blind, Placebo-Controlled, Randomized Study of Combination Vitamin E, Selenium and Soy Protein Product in Subjects With High Grade Prostatic Intraepithelial Neoplasia

    Eligibility: Documented high grade prostatic intraepithelial neoplasia (HGPIN) confirmed by the central reference pathologist. Two prostate biopsies performed within 18 months of randomization with the most recent within 6 months of randomization. Both biopsies must be negative for invasive prostate cancer.

    Objectives: To compare disease free survival, changes in serum PSA, oxidative biomarkers and hormone levels with nutrient supplement, containing vitamin E, selenium and soy protein, or placebo. To determine the association between prostate cancer development and exposure to various hypothesized risk factor for prostate cancer and to evaluate the safety of the treatment.

    NCT Registration ID (from clinicaltrials.gov): NCT00064194
    Participation: Not limited
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: November 28, 2001 Closing Date: July 23, 2004



    		Permanently Closed
    PR11

    A Phase III Study of Active Surveillance Therapy Against Radical Treatment in Patients Diagnosed with Favourable Risk Prostate Cancer (START)


    A Phase III Study of Active Surveillance Therapy Against Radical Treatment in Patients Diagnosed with Favourable Risk Prostate Cancer (START)

    Complexity Level: 2

    Eligibility: Histologically confirmed adenocarcinoma of the prostate that is negative for metastasis. Patient is a suitable candidate for radical prostatectomy or radiotherapy. No previous treatment for prostate cancer for greater than 6 months. Patient has been classified as favourable risk as defined by the following: clinical stage T1b, T1c, T2a or T2b, surgical Gleason score <= 6, PSA <= 10.0 ng/ml. For more information, please view our Patient Educational Video at the following web link: http://smaug/trials/start/start.html

    Objectives: To compare disease specific survival in patients with favourable risk prostate cancer treated with radical prostatectomy or radical radiotherapy at the time of initial diagnosis to active surveillance and selective intervention based on pre-specified biochemical, histological or clinical criteria.

    NCT Registration ID (from clinicaltrials.gov): NCT00499174
    Participation: Not limited
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 15, 2007 Closing Date: May 13, 2011



    		Permanently Closed
    PR7 (PR7)

    A Phase III Randomized Trial Comparing Intermittent Versus Continuous Androgen Suppression for Patients With Prostate-Specific-Antigen Progression in the Clinical Absence of Distant Metastases Following Radiotherapy for Prostate Cancer


    A Phase III Randomized Trial Comparing Intermittent Versus Continuous Androgen Suppression for Patients With Prostate-Specific-Antigen Progression in the Clinical Absence of Distant Metastases Following Radiotherapy for Prostate Cancer

    Complexity Level: 2

    Eligibility: Patients who completed radiotherapy to the prostate more than a year ago and who have a rising PSA > 3 ng/ml and higher than the lowest level since the end of radiotherapy without other evidence of metastasis.

    Objectives: Comparisons of overall survival, time to the development of hormone resistance, quality of life, serum cholesterol and HDL/LDL levels. Evaluate duration of treatment and non-treatment intervals, time to testosterone recovery and time to recovery of potency.

    NCT Registration ID (from clinicaltrials.gov): NCT00003653
    Participation: Limited to centres with current CPA #.
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 05, 1999 Closing Date: November 30, 2005



    		Permanently Closed
    PR5 (PR5)

    A Randomized Trial of Shorter Radiation Fractionation Schedule for the Treatment of Localized Prostate Cancer


    A Randomized Trial of Shorter Radiation Fractionation Schedule for the Treatment of Localized Prostate Cancer

    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: February 14, 1995 Closing Date: September 15, 1998



    		Permanently Closed
    PR8 (SWOG S9346)

    Phase III Study of Intermittent Androgen Deprivation in Patients With Stage D2 Prostate Cancer.


    Phase III Study of Intermittent Androgen Deprivation in Patients With Stage D2 Prostate Cancer.

    Complexity Level: 2

    Eligibility: Patients with histologically or cytologically confirmed adenocarcinoma of the prostate, clinical stage D2 as evidenced by soft tissue and/ or bony metastases.

    Objectives: To compare survival and quality of life in patients randomized to either intermittent or continuous combined androgen deprivation therapy (CAD).

    NCT Registration ID (from clinicaltrials.gov): NCT00002651
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: October 19, 1998 Closing Date: August 31, 2008



    		Permanently Closed
    BL7 (30987)

    Randomized Phase III Study Comparing Paclitaxel/Cisplatin/Gemcitabine and Cisplatin/Gemcitabine in Patients with Metastatic or Locally Advanced Urothelial Cancer without Prior Systemic Therapy


    Randomized Phase III Study Comparing Paclitaxel/Cisplatin/Gemcitabine and Cisplatin/Gemcitabine in Patients with Metastatic or Locally Advanced Urothelial Cancer without Prior Systemic Therapy

    Eligibility: Patients with locally advanced and/or metastatic cell carcinoma of the urothelium who have not had prior systemic therapy. Patients must have histologically proven stage IV locally advanced disease (T4b, N0-N1) or metastatic ((N2N3 or M10 transitional cell carcinoma of the urothelium (pure or mixed) including bladder, urethra, ureter and renal pelvis. Patients should not be suitable for surgery or radiation with curative intent. However, patients whose pre-chemotherapy sites of disease are restricted to the primary or regional lymph node sites and who have had a major response to chemotherapy will be evaluated for post-chemotherapy surgical resection of residual cancer if the tumour has become resectable at the end of chemotherapy.

    Objectives: The primary objective of this trial is to compare two treatment groups, cisplatin/ gemcitabine and cisplatin/ gemcitabine/ paclitaxel, with respect to the duration of survival. Secondary objectives are to compare in the two treatment groups the: 1) duration of progression-free survival 2) response rates (RECIST) 3)duration of response. Also to compare and characterize the nature of the toxicity experienced in each arm.

    NCT Registration ID (from clinicaltrials.gov): NCT00022191
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: December 11, 2001 Closing Date: June 01, 2004



    		Permanently Closed
    PR10 (Z0070)

    Randomized Trial of Radical Prostatectomy versus Brachytherapy for Patients With T1c or T2a N0 M0 Prostate Cancer


    Randomized Trial of Radical Prostatectomy versus Brachytherapy for Patients With T1c or T2a N0 M0 Prostate Cancer

    Eligibility: Patients must have a PSA of < 10 ng/ml. Patients must have histologically proven clinical stage T1c (usually impalpable) or T2a (unilaterally abnormality, papable or visible on TRUS), N0, M0 adenocarcinoma of the prostate, diagnosed within 120 days prior to registration on this study. Note: bilateral palpable disease is not allowed.

    Objectives: To ascertain whether patients assigned to receive brachytherapy have equal or better overall survival as compared to patients randomized to receive radical prostatectomy. To compare the two treatment arms with respect to: metastasis-free survival, the probability of survival without symptoms, side effects from the intervention and Quality of Life addressed in the companion study.

    NCT Registration ID (from clinicaltrials.gov): NCT00023686
    Participation: Limited to centres with a current CPA/FWA #
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: February 19, 2002 Closing Date: April 09, 2004



    		Permanently Closed
    REC3 (SWOG S1500)

    A Randomized, Phase II Efficacy Assessment of Multiple MET Kinase Inhibitors (Cabozantinib [NSC #761968], Crizotinib [NSC #749005],Savolitinib [NSC #785348], and Sunitinib [NSC #736511]) in Metastatic Papillary Renal Carcinoma (PAPMET)


    A Randomized, Phase II Efficacy Assessment of Multiple MET Kinase Inhibitors (Cabozantinib [NSC #761968], Crizotinib [NSC #749005],Savolitinib [NSC #785348], and Sunitinib [NSC #736511]) in Metastatic Papillary Renal Carcinoma (PAPMET)

    Complexity Level: 2

    Eligibility: Patients must have histologically or cytologically confirmed papillary renal cell carcinoma which is metastatic or locally advanced disease not amenable to surgical resection. They must also have measurable disease (RECIST), they may have received prior therapy (up to one prior systemic therapy for advanced or metastatic renal cell carcinoma or prior radiation therapy), have a Zubrod PS of 0-1, have adequate hematologic and hepatic function, and be 18 years of age or older. Patients must have tissue available and be willing to submit for central pathologic review.

    Objectives: Primary Objective: To compare progression-free survival (PFS) in patients with mPRCC treated with sunitinib to PFS in patients with mPRCC treated with MET kinase inhibitors. Secondary Objectives: a. To compare RECIST response rate (RR; defined as the combined rate of confirmed and unconfirmed PR and confirmed and unconfirmed CR) in patients with mPRCC treated with sunitinib to RR in patients treated with putative MET inhibitors. b. To compare overall survival (OS) in patients with mPRCC treated with sunitinib to OS in patients with mPRCC treated with putative MET inhibitors. c. To compare the safety profile of sunitinib and putative MET inhibitors in patients with mPRCC. Translational Objectives: To evaluate the prognostic and predictive value of MET mutations, MET copy number or other markers of MET signaling in patients with mPRCC treated with putative MET inhibitors

    NCT Registration ID (from clinicaltrials.gov): NCT02761057
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: July 27, 2016 Closing Date: December 15, 2019



    		Permanently Closed

    Gynecologic

    IDStudy TitleStatus
    EN10

    A Phase II Study of Tailored Adjuvant Therapy in POLE-mutated and p53-wildtype/NSMP Early Stage Endometrial Cancer (RAINBO BLUE & TAPER)

    This protocol tests de-escalated adjuvant treatment in patients with POLE-mutated or p53wt/NSMP (p53 wildtype/no specific molecular profile) in early-stage endometrial cancer (EC). The purpose of the study is to identify women who may not require additional treatment or may require less treatment because they are at such a low risk of recurrence.

    A Phase II Study of Tailored Adjuvant Therapy in POLE-mutated and p53-wildtype/NSMP Early Stage Endometrial Cancer (RAINBO BLUE & TAPER)

    Complexity Level: 2

    Eligibility: Sub-study A, Cohort A1: with early-stage POLE-mutated EC; Sub-study A, Cohort A2-Exploratory: with higher-risk POLE-mutated EC; Sub-study B: with p53wt/NSMP ER+ EC

    Objectives: Primary Objective: Estimate the rate of pelvic recurrence at 3 years in patients who are treated with a de-escalated adjuvant treatment directed by tumour molecular status

    NCT Registration ID (from clinicaltrials.gov): NCT05640999
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: CCTG Led Trial
    Status: Open to Accrual
    Activation Date: December 19, 2022



    		Open to Accrual
    VU2

    STRatIfication of Vulvar squamous cell carcinoma by HPV and p53 status to guide Excision: STRIVE Study

    To estimate the 3-year local recurrence rates in participants with HPV-associated (HPV-A) and HPV-independent (HPV-I) vulvar squamous cell carcinoma (VSCC) where surgically management is based on dVIN/p53 status and tumour margin clearance.

    STRatIfication of Vulvar squamous cell carcinoma by HPV and p53 status to guide Excision: STRIVE Study

    Complexity Level: 2

    Eligibility: Histologically confirmed primary diagnosis of vulvar squamous cell carcinoma (VSSC). Surgically staged FIGO I-II VSCC. Vulvar resection according to standard of care guidelines. Post-operative margin assessment of tumour clearance, dVIN, and p53 status. Participants must be >/= 18 years old. Participants must enroll within 60 days of primary vulvar surgery. Local reference pathologist(s) review has been performed.

    Objectives: Primary: Estimate the 3-year local recurrence rates in participants with HPV-independent (HPV-I) and HPV-associated (HPV-A) VSCC surgically managed based on dVIN/p53 status and tumour margin clearance. Secondary: Estimate RFS, DSS and OS in both the HPV-I and HPV-A cohorts. Estimate health economic impact of surgical management based on molecular stratification and margin status in both cohorts. Describe PROs in both cohorts. Estimate recurrence rates of vulvar dVIN and/or p53abn (HPV-I cohort only). Exploratory: Identify prognostic or predictive molecular biomarkers in HPV-I and HPV-A VSCC.

    NCT Registration ID (from clinicaltrials.gov): NCT06358469
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: CCTG Led Trial
    Status: Open to Accrual
    Activation Date: October 01, 2024



    		Open to Accrual
    EN11 (RAINBO GREEN)

    RAINBO: Refining Adjuvant treatment IN endometrial cancer Based On molecular features, TransPORTEC platform trials - The MMRD-GREEN trial


    RAINBO: Refining Adjuvant treatment IN endometrial cancer Based On molecular features, TransPORTEC platform trials - The MMRD-GREEN trial

    Complexity Level: 2

    Eligibility: Histologically confirmed diagnosis of EC of the following histologic subtypes: endometrioid endometrial carcinoma, serous endometrial carcinoma, uterine clear cell carcinoma, dedifferentiated and undifferentiated endometrial carcinoma, uterine carcinosarcoma, and mixed endometrial carcinomas of the aforementioned histotypes.Full molecular classification performed following the diagnostic algorithm described in WHO 2020. TLH-BSO or TAH-BSO with or without lymphadenectomy or sentinel node biopsy, without macroscopic residual disease after surgery. Molecular classification: MMRd EC (POLE status must be determined, and must be wildtype (or non-pathogenic) for inclusion.)

    Objectives: 2.1. Primary objective • 3-year RFS 2.2. Secondary objectives • RFS median and at 5 years • Vaginal RFS, pelvic RFS, distant metastasis free-survival (median, 3-year, 5-year) • Disease-specific survival (median, 3-year, 5-year) • OS (median, 3-year, 5-year) • HRQoL (EORTC QLQC30 and QLQEN24) • Safety & tolerability (NCI-CTC grade 3-5) • Explorative translational research , such as analysis PD-L1 positive subgroup (using SP263 assay (>1% and 5%).

    NCT Registration ID (from clinicaltrials.gov): NCT05255653-2
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: On Hold
    Activation Date: July 07, 2023



    		On Hold
    CXC2 (NRG GY006)

    A Randomized Phase III Trial of Radiation Therapy and Cisplatin Alone or in Combination with Intravenous Triapine in Women with Newly Diagnosed Bulky Stage IB2, Stage II, IIIB, or IVA Cancer of the Uterine Cervix or Stage II-IVA Vaginal Cancer


    A Randomized Phase III Trial of Radiation Therapy and Cisplatin Alone or in Combination with Intravenous Triapine in Women with Newly Diagnosed Bulky Stage IB2, Stage II, IIIB, or IVA Cancer of the Uterine Cervix or Stage II-IVA Vaginal Cancer

    Complexity Level: 2

    Eligibility: Patient has a new, untreated histologic diagnosis of stage IB2 (> 4 cm), II, IIIB or IVA squamous, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix (FIGO 2009) or stage II-IVA squamous, adenocarcinoma, or adenosquamous carcinoma of the vagina not amenable to curative surgical resection alone. The presence or absence of para-aortic lymph node metastasis will be based on pre-therapy (18)F FDG PET/CT. NOTE: If the baseline (18)F FDG PET/CT identifies hypermetabolic para-aortic disease, such patients will NOT be eligible. The patient must be able to tolerate imaging requirements of an (18)F FDG PET/CT scan.

    Objectives: Primary Objective:To evaluate the efficacy of the experimental regimen of triapine (3AP), cisplatin, and radiation to increase overall survival relative to the standard / control regimen of cisplatin and radiation in women with uterine cervix or vaginal cancer. Secondary Objective: To determine the relative progression-free survival impact of triapine-cisplatin radio-chemotherapy and cisplatin radio-chemotherapy.

    NCT Registration ID (from clinicaltrials.gov): NCT02466971
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: April 30, 2021 Closing Date: September 22, 2022



    		Closed to Accrual
    OV25

    A Randomized Phase II Double-Blind Placebo-Controlled Trial of Acetylsalicylic Acid (ASA) in Prevention of Ovarian Cancer in Women with BRCA 1/2 Mutations (STICs and STONEs)


    A Randomized Phase II Double-Blind Placebo-Controlled Trial of Acetylsalicylic Acid (ASA) in Prevention of Ovarian Cancer in Women with BRCA 1/2 Mutations (STICs and STONEs)

    Complexity Level: 2

    Eligibility: Women with documented germline BRCA 1/2 mutations, scheduled to undergo risk-reducing surgery (bilateral salpingo-oophorectomy or bilateral salpingectomy inclusive of fimbria) within 6 months to 2 years after the date of randomization.

    Objectives: PRIMARY OBJECTIVE: To compare the frequency of pre- & early-malignant lesions (serous tubal intraepithelial carcinomas (STICs) or serous tubal occult neoplasias - early (STONEs) in the fallopian tube, at the time of risk reducing surgery. SECONDARY OBJECTIVE: To assess subject acceptance of ASA intervention in a female cohort at high risk for ovarian cancer. TERTIARY OBJECTIVES: (1) To characterize the effect of ASA on high grade serous ovarian cancer (HGSOC) tumourigenesis and to examine the linkage between tumourigenesis and microenvironment. (2) Biobanking for future correlative studies

    NCT Registration ID (from clinicaltrials.gov): NCT03480776
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Closed to Accrual
    Activation Date: April 06, 2018 Closing Date: December 15, 2022



    		Closed to Accrual
    ENC1 (NRG GY018)

    A Phase III Randomized, Placebo-Controlled Study of Pembrolizumab (MK-3475, NSC#776864) in Addition to Paclitaxel and Carboplatin for Measurable Stage III or IVA, Stage IVB or Recurrent Endometrial Cancer


    A Phase III Randomized, Placebo-Controlled Study of Pembrolizumab (MK-3475, NSC#776864) in Addition to Paclitaxel and Carboplatin for Measurable Stage III or IVA, Stage IVB or Recurrent Endometrial Cancer

    Complexity Level: 2

    Eligibility: women with measurable stage III, measurable stage IVA, stage IVB (with or without measurable disease) or recurrent (with or without measurable disease) endometrial cancer.

    Objectives: Primary Objective: To evaluate the efficacy of pembrolizumab in combination with paclitaxel and carboplatin in patients with advanced stage (measurable stage III or IVA), stage IVB and recurrent endometrial cancer. Efficacy will be determined via investigator assessed progression free survival (PFS) in two distinct populations referred to as proficient and deficient mismatch repair (pMMR and dMMR).

    NCT Registration ID (from clinicaltrials.gov): NCT03914612
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: October 29, 2019 Closing Date: December 06, 2022



    		Closed to Accrual
    OVC1 (NRG GY004)

    A Phase III Study Comparing Single-agent Olaparib or the Combination of Cediranib and Olaparib to Standard Platinum-based Chemotherapy in Women with Recurrent Platinum-sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer


    A Phase III Study Comparing Single-agent Olaparib or the Combination of Cediranib and Olaparib to Standard Platinum-based Chemotherapy in Women with Recurrent Platinum-sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

    Complexity Level: 2

    Eligibility: women with recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer

    Objectives: Primary Objective: Assess the efficacy of either single agent olaparib or the combination of cediranib and olaparib, as measured by PFS, as compared to standard platinum-based chemotherapy in the setting of recurrent platinum-sensitive ovarian, primary peritoneal or fallopian tube cancer. Secondary Objectives:Assess the efficacy of single agent olaparib or the combination of cediranib and olaparib, as measured by response rate, and overall survival as compared to standard platinum-based chemotherapy in the setting of recurrent platinum-sensitive ovarian, primary peritoneal or fallopian tube cancer.

    NCT Registration ID (from clinicaltrials.gov): NCT02446600
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: January 04, 2017 Closing Date: November 10, 2017



    		Closed to Accrual
    OVC2 (NRG GY005)

    A Randomized Phase II/III study of the Combination of Cediranib and Olaparib Compared to Cediranib or Olaparib Alone, or Standard of Care Chemotherapy in Women with Recurrent Platinum-resistant or -Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (COCOS)


    A Randomized Phase II/III study of the Combination of Cediranib and Olaparib Compared to Cediranib or Olaparib Alone, or Standard of Care Chemotherapy in Women with Recurrent Platinum-resistant or -Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (COCOS)

    Complexity Level: 2

    Eligibility: women with recurrent platinum-resistant or -refractory ovarian, fallopian tube, or primary peritoneal cancer

    Objectives: Primary Objective: To assess the efficacy and identify (in)active arm(s) of the combination of cediranib and olaparib, cediranib alone, olaparib alone, and physician's choice standard of care chemotherapy, as measured by PFS in the setting of recurrent platinum-resistant or-refractory ovarian, primary peritoneal or fallopian tube cancer. Secondary Objectives: - To assess the efficacy of the combination of cediranib and olaparib, cediranib alone, olaparib alone, and physician's choice standard of care chemotherapy, as measured by objective response rate (ORR: partial or complete response) by RECIST criteria, in the setting of recurrent platinum-resistant or-refractory ovarian, primary peritoneal or fallopian tube cancer. - To assess safety endpoints, as measured by frequency and severity of adverse events by Common Terminology Criteria for Adverse Events

    NCT Registration ID (from clinicaltrials.gov): NCT02502266
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: January 19, 2017 Closing Date: October 02, 2020



    		Closed to Accrual
    CX6 (GINECO CE106)

    International Validation Study of Sentinel Node Biopsy in Early Cervical Cancer SENTICOL III


    International Validation Study of Sentinel Node Biopsy in Early Cervical Cancer SENTICOL III

    Complexity Level: 2

    Eligibility: - With squamous or adenocarcinoma of the cervix (proven by biopsy or cone biopsy), - Stage Ia1 with lymphovascular emboli, Ia2, Ib1 IIa1, Ib2 (clinical stage) of the 2018 FIGO classification (see appendix 1), - Maximum diameter . 40 mm by clinical examination and/or magnetic resonance imaging (MRI), - No suspicious node on pelvic MRI with an exploration up to the left renal vein (according to RECIST 1.1),

    Objectives: - To assess that Disease Free Survival (DFS) is similar between pN0 patients after SLN biopsy versus SLN biopsy + PLN - To assess a superiority of SLN biopsy for quality of life (HR-QoL)

    NCT Registration ID (from clinicaltrials.gov): NCT03386734
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: July 24, 2020 Closing Date: May 27, 2024



    		Closed to Accrual
    OV26 (CRUK/UCL ICON9)

    An International Phase III Randomised Study to Evaluate the Efficacy of Maintenance Therapy with Olaparib and Cediranib or Olaparib Alone in Patients with Relapsed Platinum-sensitive Ovarian Cancer Following a Response to Platinum-Based Chemotherapy


    An International Phase III Randomised Study to Evaluate the Efficacy of Maintenance Therapy with Olaparib and Cediranib or Olaparib Alone in Patients with Relapsed Platinum-sensitive Ovarian Cancer Following a Response to Platinum-Based Chemotherapy

    Complexity Level: 2

    Eligibility: Histologically proven diagnosis of high grade serous or endometrioid carcinoma of the ovary, fallopian tube or peritoneum, progressing more than 6 months after day 1 of the last cycle of first-line platinum-based chemotherapy and requiring treatment with second-line platinum-based chemotherapy. CT or MRI proven relapsed disease at first recurrence (measurable or non-measurable) prior to starting second-line treatment or surgically debulking. Completed a minimum of 4 cycles of platinum-based chemotherapy for first relapse (2nd line treatment)

    Objectives: I. Progression free survival (PFS) measured from the date of randomisation to the date of objective progression (investigator assessed using RECIST v1.1) or date of death from any cause (in the absence of progression) II. Overall survival measured from the date of randomisation to the date of death from any cause I. Toxicity II. Adherence to maintenance therapy- compliance and dose reductions and interruptions III. PFS and OS measured from the start of second-line chemotherapy IV. TSST (the time from randomisation to start of second subsequent treatment or death) V. Quality of Life using EORTC QLQC30 and OV28 VI. Cost effectiveness using EQ-5D-5L for economic evaluation VII. Progression free survival by CA125 - GCIG criteria VIII. Response rate (RECIST v1.1 and/or CA125) at 16 weeks of treatment in patients who had RECIST v1.1 measurable disease or elevated CA125 at randomisation. RECIST measurements will be based on investigator assessment not central review

    NCT Registration ID (from clinicaltrials.gov): NCT03278717
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: November 26, 2020 Closing Date: May 24, 2023



    		Closed to Accrual
    OV3

    Second Co-operative Clinical Trial on Treatment of Ovarian Carcinoma


    Second Co-operative Clinical Trial on Treatment of Ovarian Carcinoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: March 16, 1978 Closing Date: May 14, 1979



    		Permanently Closed
    OV11 (9619)

    A Phase II Trial of Intraperitoneal Cisplatin and Intravenous and Intraperitoneal Paclitaxel in Women with Optimally-Debulked Stage III Epithelial Ovarian Cancer


    A Phase II Trial of Intraperitoneal Cisplatin and Intravenous and Intraperitoneal Paclitaxel in Women with Optimally-Debulked Stage III Epithelial Ovarian Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: June 21, 1996 Closing Date: May 15, 1998



    		Permanently Closed
    OV5A

    Pilot Study of Weekly Adriamycin and Cisplatinum With Co-Trimoxazole Coverage in Patients With Stage III And IV Ovarian Cancer


    Pilot Study of Weekly Adriamycin and Cisplatinum With Co-Trimoxazole Coverage in Patients With Stage III And IV Ovarian Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 22, 1983 Closing Date: May 01, 1984



    		Permanently Closed
    OV10 (55931)

    Intergroup Phase III Comparison of a Combination of TAXOL-Platinum and a Combination of Cyclophosphamide-Platinum Chemotherapy in the Treatment of Advanced Epithelial Ovarian Cancer.


    Intergroup Phase III Comparison of a Combination of TAXOL-Platinum and a Combination of Cyclophosphamide-Platinum Chemotherapy in the Treatment of Advanced Epithelial Ovarian Cancer.

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: June 03, 1994 Closing Date: July 31, 1995



    		Permanently Closed
    OV9

    A Multicentre, Randomized Comparative Study of Taxol in Platinum Treated Ovarian Cancer (High vs. Low Dose; Long vs. Short Infusion)


    A Multicentre, Randomized Comparative Study of Taxol in Platinum Treated Ovarian Cancer (High vs. Low Dose; Long vs. Short Infusion)

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 06, 1991 Closing Date: March 06, 1992



    		Permanently Closed
    CXC1 (0219)

    A Phase III, Randomized Trial of Weekly Cisplatin and Radiation versus Cisplatin and Tirapazamine and Radiation in Stage 1B2, IIA, IIB, IIIB and IVA Cervical Carcinoma Limited to the Pelvis.


    A Phase III, Randomized Trial of Weekly Cisplatin and Radiation versus Cisplatin and Tirapazamine and Radiation in Stage 1B2, IIA, IIB, IIIB and IVA Cervical Carcinoma Limited to the Pelvis.

    Complexity Level: 2

    Eligibility: Patients with histologically confirmed invasive squamous cell, adenocarcinoma, or adenosquamous carcinoma of the cervix stages IB2, IIA, IIB, IIIB or IVA.

    Objectives: To determine if combining TPZ with cisplatin during radiation therapy increases recurrence-free survival(RFS) when compared with weekly cisplatin and radiation therapy in this patient population.

    NCT Registration ID (from clinicaltrials.gov): NCT00262821
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: July 20, 2006 Closing Date: September 01, 2009



    		Permanently Closed
    OV14 (OC9804)

    An International Randomized Phase III Trial of Paclitaxel/Epirubicin/Carboplatin Combination (TEC) versus Paclitaxel/Carboplatin (TC) in the Initial Treatment of Women with Advanced Ovarian Cancer


    An International Randomized Phase III Trial of Paclitaxel/Epirubicin/Carboplatin Combination (TEC) versus Paclitaxel/Carboplatin (TC) in the Initial Treatment of Women with Advanced Ovarian Cancer

    Eligibility: Patients with a clinical diagnosis consistent with FIGO Stage IIB-IV invasive epithelial ovarian, fallopian tube or peritoneal cancer.

    Objectives: Primary: Progression-free survival Secondary: Overall survival, Compare the relative toxicity of the two regimens and analysis of Quality of Life.

    NCT Registration ID (from clinicaltrials.gov): NCT00004934
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: May 14, 1999 Closing Date: July 31, 2001



    		Permanently Closed
    OV12

    A Phase III Comparison of BAY 12-9566 versus Placebo as Consolidation After Standard Chemotherapy in Patients with Epithelial Ovarian Cancer


    A Phase III Comparison of BAY 12-9566 versus Placebo as Consolidation After Standard Chemotherapy in Patients with Epithelial Ovarian Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: May 06, 1998 Closing Date: September 20, 1999



    		Permanently Closed
    OV4

    Third Cooperative Clinical Trial on Treatment of Advanced Ovarian Carcinoma


    Third Cooperative Clinical Trial on Treatment of Advanced Ovarian Carcinoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: December 08, 1980 Closing Date: March 31, 1984



    		Permanently Closed
    OV18 (MRC ICON6)

    A Randomised, Placebo-controlled, Trial of Concurrent Cediranib [AZD2171] (with platinum-based chemotherapy) and Concurrent and Maintenance Cediranib in Women with Platinum-sensitive Relapsed Ovarian Cancer


    A Randomised, Placebo-controlled, Trial of Concurrent Cediranib [AZD2171] (with platinum-based chemotherapy) and Concurrent and Maintenance Cediranib in Women with Platinum-sensitive Relapsed Ovarian Cancer

    Complexity Level: 2

    Eligibility: Patients with relapsed epithelial ovarian, fallopian tube or primary serous peritoneal carcinoma who require platinum-based chemotherapy for first relapse 6 or more months after the last dose of first-line platinum-based therapy.

    Objectives: Primary: Overall Survival, Progression-free survival and tolerability. Secondary: Toxicity, Quality of Life, Health Economics and Molecular Biology.

    NCT Registration ID (from clinicaltrials.gov): NCT00532194
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: April 02, 2008 Closing Date: December 14, 2011



    		Permanently Closed
    OV15 (OVAR 2.5)

    International Randomized Phase III Study Comparing Gemcitabine Plus Carboplatin Versus Carboplatin Monotherapy in Patients with Advanced Epithelial Ovarian Carcinoma Who Failed First-Line Platinum-Based Therapy


    International Randomized Phase III Study Comparing Gemcitabine Plus Carboplatin Versus Carboplatin Monotherapy in Patients with Advanced Epithelial Ovarian Carcinoma Who Failed First-Line Platinum-Based Therapy

    Eligibility: Patients with histologically proven ovarian carcinoma with evidence of recurrence or progression, which is not amenable to curative surgery or radiotherapy. Patients must have failed first-line platinum-containing therapy more than 6 months after treatment discontinuation.

    Objectives: To compare the time to progressive disease (TTPD) in patients treated with gemcitabine plus carboplatin versus carboplatin monotherapy. The secondary objectives of this study are to compare the following in the two arms: response rate, duration of response, survival time, toxicity, and changes in quality of life over time.

    NCT Registration ID (from clinicaltrials.gov): NCT00006453
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: October 17, 2000 Closing Date: April 15, 2002



    		Permanently Closed
    CX5 (CX5)

    A Randomized Phase III Trial Comparing Radical Hysterectomy and Pelvic Node Dissection vs Simple Hysterectomy and Pelvic Node Dissection in Patients with Low-Risk Early Stage Cervical Cancer. (SHAPE)


    A Randomized Phase III Trial Comparing Radical Hysterectomy and Pelvic Node Dissection vs Simple Hysterectomy and Pelvic Node Dissection in Patients with Low-Risk Early Stage Cervical Cancer. (SHAPE)

    Complexity Level: 1

    Eligibility: Histologically confirmed adenocarcinoma, squamous, or adenosquamous cancer of the cervix. Diagnosis has been made by LEEP, cone or cervical biopsy and has been reviewed and confirmed by the local reference gynecological pathologist.

    Objectives: Evaluate whether treatment with radical hysterectomy and pelvic node dissection is non-inferior to treatment with simple hysterectomy and pelvic node dissection in terms of pelvic-relapse free survival. Compare the rates of treatment-related toxicity, extrapelvic relapse-free survival, and overall survival. Compare rates of sentinel node detection, and rates of parametrial, margins and pelvic nodes involvement Compare quality of life (including sexual health)

    NCT Registration ID (from clinicaltrials.gov): NCT01658930
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 02, 2012 Closing Date: November 29, 2019



    		Permanently Closed
    OV6

    Non-Randomized Study to Determine the Efficacy of Surgery Alone in Patients With Stage IA Or IB Epithelial Ovarian Carcinoma When Extensive Surgical Staging Has Been Done to Confirm Limited Disease


    Non-Randomized Study to Determine the Efficacy of Surgery Alone in Patients With Stage IA Or IB Epithelial Ovarian Carcinoma When Extensive Surgical Staging Has Been Done to Confirm Limited Disease

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: September 10, 1984 Closing Date: March 18, 1988



    		Permanently Closed
    OV8A

    Pilot Study of Cyclophosphamide and Cisplatin in Patients With Ovarian Cancer


    Pilot Study of Cyclophosphamide and Cisplatin in Patients With Ovarian Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: December 03, 1984 Closing Date: May 06, 1985



    		Permanently Closed
    OV19 (MRC ICON7)

    A Randomized, Two-Arm, Multi-Center Gynecologic Cancer Intergroup Trial of Adding Bevacizumab To Standard Chemotherapy (Carboplatin And Paclitaxel) In Patients With Epithelial Ovarian Cancer.


    A Randomized, Two-Arm, Multi-Center Gynecologic Cancer Intergroup Trial of Adding Bevacizumab To Standard Chemotherapy (Carboplatin And Paclitaxel) In Patients With Epithelial Ovarian Cancer.

    Complexity Level: 2

    Eligibility: ICON7 will include patients with newly diagnosed, histologically confirmed, high risk FIGO stage I and IIa (Grade 3 or clear cell carcinoma only) and FIGO stage IIb - IV (all grades and all histological types) epithelial ovarian, fallopian tube or primary peritoneal cancer, who have undergone initial surgery (either debulking cytoreductive surgery or a biopsy if the patient has FIGO stage IV disease) and who will not be considered for cytoreductive surgery prior to disease progression. Patients with measurable and non-measurable disease (see Appendix 10) are eligible.

    Objectives: Primary: Progression-free survival. Secondary: Overall survival, Response rate (rate and duration), Adverse events, Quality of Life, Health Economics and Translational Research.

    NCT Registration ID (from clinicaltrials.gov): NCT00483782
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: March 19, 2007 Closing Date: February 13, 2009



    		Permanently Closed
    CX1

    A Phase II Study to Evaluate the Toxicity and Efficacy of Concurrent Cisplatin and Radiation Therapy in the Treatment of Patients with Locally Advanced Squamous Cell Carcinoma of the Cervix


    A Phase II Study to Evaluate the Toxicity and Efficacy of Concurrent Cisplatin and Radiation Therapy in the Treatment of Patients with Locally Advanced Squamous Cell Carcinoma of the Cervix

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: May 01, 1990 Closing Date: April 12, 1991



    		Permanently Closed
    OV17 (CALYPSO)

    A Multi-National, Randomized, Phase III, GCIG Intergroup Study Comparing Pegylated Liposomal Doxorubicin (Caelyx) and Carboplatin vs. Paclitaxel and Carboplatin in Patients with Epithelial Ovarian Cancer in Late Relapse (>6 months): GCIG Calypso Study


    A Multi-National, Randomized, Phase III, GCIG Intergroup Study Comparing Pegylated Liposomal Doxorubicin (Caelyx) and Carboplatin vs. Paclitaxel and Carboplatin in Patients with Epithelial Ovarian Cancer in Late Relapse (>6 months): GCIG Calypso Study

    Complexity Level: 2

    Eligibility: Epithelial cancer of the ovary in progression > 6 months (late relapse) after a first or a second line including a platinum-derivative. Patients should have received previously a taxane.

    Objectives: Primary objective: Progression-free survival (PFS) between both treatment groups Secondary objectives Overall survival (OS) Toxicities Quality of life (QOL)

    NCT Registration ID (from clinicaltrials.gov): NCT00189553
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: October 17, 2005 Closing Date: September 25, 2007



    		Permanently Closed
    EN5

    A Phase III Randomized Trial Comparing TAH BSO versus TAH BSO Plus Adjuvant Pelvic Irradiation in Intermediate Risk, Carcinoma of the Endometrium


    A Phase III Randomized Trial Comparing TAH BSO versus TAH BSO Plus Adjuvant Pelvic Irradiation in Intermediate Risk, Carcinoma of the Endometrium

    Eligibility: Patients with histologically confirmed adenocarcinoma of the endometrium (Stage IA [grade 3] or IB [grade 3] or IC [grade 1 or 2 or 3]) or stage IIA treated by total abdominal hysterectomy with bilateral salpingo-oophorectomy who have not received prior pelvic radiotherapy. Patients may receive first-line brachytherapy (if local standard).

    Objectives: In collaboration with the MRC UK ASTEC trial analysis, to compare overall survival; to evaluate the differences in recurrence-free survival, duration of pelvic control and toxicity and tolerability. Canadian components to analyse quality of life and sexual health.

    NCT Registration ID (from clinicaltrials.gov): NCT00002807
    Participation: Not limited
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 04, 1996 Closing Date: March 31, 2005



    		Permanently Closed
    CX3

    A Phase III Randomized Study of Cisplatin Alone versus a Combination of Etoposide, Ifosfamide and Cisplatin (VIP) in the Treatment of Persistent, Recurrent or Advanced Squamous or Adenosquamous Cell Carcinoma of the Cervix


    A Phase III Randomized Study of Cisplatin Alone versus a Combination of Etoposide, Ifosfamide and Cisplatin (VIP) in the Treatment of Persistent, Recurrent or Advanced Squamous or Adenosquamous Cell Carcinoma of the Cervix

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: October 16, 1992 Closing Date: November 19, 1993



    		Permanently Closed
    EN7 (DCGOG PORTEC-3)

    Randomized Phase III Trial Comparing Concurrent Chemoradiation and Adjuvant Chemotherapy with Pelvic Radiation Alone in High Risk and Advanced Stage Endometrial Carcinoma.


    Randomized Phase III Trial Comparing Concurrent Chemoradiation and Adjuvant Chemotherapy with Pelvic Radiation Alone in High Risk and Advanced Stage Endometrial Carcinoma.

    Complexity Level: 2

    Eligibility: Histologically confirmed endometrial carcinoma, grade of differentiation determined according to the FIGO/AFIP criteria, with one of the following postoperative FIGO 2009 stages; confirmed at pathology review: Stage IA with myometrial invasion, grade 3 with documented lymph-vascular space invasion (LVSI); Stage IB grade 3; Stage II; Stage IIIA or IIIC; or IIIB if parametrial invasion; Stage IA with myometrial invasion, IB, II or IIIA/C with serous or clear cell histology.

    Objectives: Overall and failure free survival; toxicity; Quality of Life; Pelvic and distant recurrence; Translational studies on paraffin fixed tissue.

    NCT Registration ID (from clinicaltrials.gov): NCT00411138
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: September 03, 2008 Closing Date: December 20, 2013



    		Permanently Closed
    OV2

    A Clinical Trial of Radiotherapy and Chemotherapy With Melphalan Following Surgery for Patients With Limited (Stage I, II & IIIo) Carcinoma of the Ovary


    A Clinical Trial of Radiotherapy and Chemotherapy With Melphalan Following Surgery for Patients With Limited (Stage I, II & IIIo) Carcinoma of the Ovary

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: May 20, 1975 Closing Date: March 31, 1984



    		Permanently Closed
    OV7

    Clinical Trial Comparing Abdominal-Pelvic Radiation versus Cyclophosphamide and Cisplatin Chemotherapy in Patients With Epithelial Ovarian Carcinoma Having Only Microscopic Residual Disease Following Surgery


    Clinical Trial Comparing Abdominal-Pelvic Radiation versus Cyclophosphamide and Cisplatin Chemotherapy in Patients With Epithelial Ovarian Carcinoma Having Only Microscopic Residual Disease Following Surgery

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 29, 1985 Closing Date: March 16, 1988



    		Permanently Closed
    GT1 (0174)

    A Randomized Phase III Trial of Weekly Parenteral Methotrexate Versus "Pulsed" Dactinomycin for Primary Management of Low Risk Gestational Trophoblastic Neoplasia


    A Randomized Phase III Trial of Weekly Parenteral Methotrexate Versus "Pulsed" Dactinomycin for Primary Management of Low Risk Gestational Trophoblastic Neoplasia

    Eligibility: Patients with untreated, histologically confirmed low risk GTN (persistent hydatidform mole or choriocarcinoma). Patients must have a pretreatment WHO score of 0 - 6 and a GOG performance status of 0 - 2.

    Objectives: To determine whether weekly parenteral methotrexate or "pulsed" dactinomycin is the more effective treatment for low risk gestational trophoblastic neoplasia. To prospectively determine and compare the toxicity of each regimen. To prospectively determine whether the definition of persistent GTN is accurate.

    NCT Registration ID (from clinicaltrials.gov): NCT00003702
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: October 18, 2000 Closing Date: February 26, 2007



    		Permanently Closed
    OV13 (EORTC 55971)

    An International Multi-Centre Randomized Phase III Study Comparing Upfront Debulking Surgery Versus Neo-Adjuvant Chemotherapy in Patients With Stage IIIC or IV Epithelial Ovarian Carcinoma


    An International Multi-Centre Randomized Phase III Study Comparing Upfront Debulking Surgery Versus Neo-Adjuvant Chemotherapy in Patients With Stage IIIC or IV Epithelial Ovarian Carcinoma

    Complexity Level: 2

    Eligibility: Patients with histologically confirmed stage IIIc or IV epithelial ovarian, peritoneal or fallopian tube carcinoma with a performance status of < 2 (WHO), adequate blood counts and liver and renal function.

    Objectives: To compare overall survival; to evaluate the differences in progression free survival, toxicity and tolerability and quality of life.

    NCT Registration ID (from clinicaltrials.gov): NCT00003636
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: May 13, 1999 Closing Date: November 30, 2006



    		Permanently Closed
    CX4 (0191)

    Phase III trial to Evaluate the Efficacy of Maintaining Hemoglobin Levels Above 120 g/L with Erythropoietin Versus Above 100 g/L without Erythropoietin in Anemic Patients Receiving Concurrent Radiation and Cisplatin for Cervical Cancer


    Phase III trial to Evaluate the Efficacy of Maintaining Hemoglobin Levels Above 120 g/L with Erythropoietin Versus Above 100 g/L without Erythropoietin in Anemic Patients Receiving Concurrent Radiation and Cisplatin for Cervical Cancer

    Complexity Level: 2

    Eligibility: Patients with primary, previously untreated, histologically confirmed invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix, Stage II-B, III-B, IV-A.

    Objectives: To assess the efficacy of raising and maintaining patient hemoglobin level above 120 g/L using erythropoietin compared to maintenance level above 100 g/L without erythropoietin on progression-free survival, overall survival and local control in anemic patients with carcinoma of the cervix receiving concurrent radiation and cisplatin treatment.

    NCT Registration ID (from clinicaltrials.gov): NCT00017004
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: October 19, 2001 Closing Date: January 17, 2004



    		Permanently Closed
    EN4 (55874)

    Intergroup (EORTC, NCIC CTG) Phase III Study to Evaluate the Role of Adjuvant Radiotherapy in the Treatment of Uterine Sarcomas Stages I and II


    Intergroup (EORTC, NCIC CTG) Phase III Study to Evaluate the Role of Adjuvant Radiotherapy in the Treatment of Uterine Sarcomas Stages I and II

    NCT Registration ID (from clinicaltrials.gov): NCT00002459
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: June 26, 1995 Closing Date: August 10, 2001



    		Permanently Closed
    OV8

    Clinical Trial Examining the Treatment of Patients With Macroscopic Residual Epithelial Ovarian Carcinoma. Part I - The Comparison of Cyclophosphamide and Cisplatin Versus Cyclophosphamide and Carboplatin as Initial Treatment Part II - The Comparison of Whole Abdominal Radiation versus Continuing Chemotherapy in Patients on Part I of the Study


    Clinical Trial Examining the Treatment of Patients With Macroscopic Residual Epithelial Ovarian Carcinoma. Part I - The Comparison of Cyclophosphamide and Cisplatin Versus Cyclophosphamide and Carboplatin as Initial Treatment Part II - The Comparison of Whole Abdominal Radiation versus Continuing Chemotherapy in Patients on Part I of the Study

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 07, 1985 Closing Date: March 17, 1989



    		Permanently Closed
    OV21 (OV21)

    A Phase II Study of Intraperitoneal (IP) Plus Intravenous (IV) Chemotherapy Versus IV Carboplatin Plus Paclitaxel in Patients With Epithelial Ovarian Cancer Optimally Debulked at Surgery Following Neoadjuvant Intravenous Chemotherapy.


    A Phase II Study of Intraperitoneal (IP) Plus Intravenous (IV) Chemotherapy Versus IV Carboplatin Plus Paclitaxel in Patients With Epithelial Ovarian Cancer Optimally Debulked at Surgery Following Neoadjuvant Intravenous Chemotherapy.

    Complexity Level: 1

    Eligibility: Epithelial Ovarian Cancer Primary Peritoneal Carcinoma Fallopian Tube Carcinoma

    Objectives: 9 month progression rate following randomization Progression-Free Survival, Overall Survival, Toxic Effects, Quality of Life

    NCT Registration ID (from clinicaltrials.gov): NCT00993655
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: September 11, 2009 Closing Date: May 27, 2015



    		Permanently Closed
    OV1

    Treatment of Patients With Advanced Ovarian Carcinoma (Stages III and IV) With Melphalan, 5 Fluorouracil and Methotrexate in Combination and Sequentially


    Treatment of Patients With Advanced Ovarian Carcinoma (Stages III and IV) With Melphalan, 5 Fluorouracil and Methotrexate in Combination and Sequentially

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 04, 1974 Closing Date: March 07, 1977



    		Permanently Closed
    EN1

    Chemotherapy of Stage IV Metastatic and Recurrent Carcinoma of the Uterine Corpus


    Chemotherapy of Stage IV Metastatic and Recurrent Carcinoma of the Uterine Corpus

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 06, 1975 Closing Date: November 11, 1980



    		Permanently Closed
    CX2

    A Phase III Study Comparing Concurrent Cisplatin and Radiation Therapy versus Radiation Alone for Locally Advanced Squamous Cell Carcinoma of the Cervix


    A Phase III Study Comparing Concurrent Cisplatin and Radiation Therapy versus Radiation Alone for Locally Advanced Squamous Cell Carcinoma of the Cervix

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 12, 1991 Closing Date: September 30, 1996



    		Permanently Closed
    OV16 (OV16)

    A Phase III Study of Cisplatin Plus Topotecan Followed by Paciltaxel plus Carboplatin versus Paclitaxel plus Carboplatin as First Line Chemotherapy in Women with Newly Diagnosed Advanced Epithelial Ovarian Cancer


    A Phase III Study of Cisplatin Plus Topotecan Followed by Paciltaxel plus Carboplatin versus Paclitaxel plus Carboplatin as First Line Chemotherapy in Women with Newly Diagnosed Advanced Epithelial Ovarian Cancer

    Complexity Level: 2

    Eligibility: Patients with confirmed epithelial ovarian (or primary fallopian or peritoneal) cancer, Stage IIB to IV, with microscopic or macroscopic residual disease who have not received prior chemotherapy and have evidence of adequate organ function.

    Objectives: Primary: to compare progression free survival. Secondary: to compare overall survival, response rates, toxic effects, quality of life, and CA 125 normalization rates.

    NCT Registration ID (from clinicaltrials.gov): NCT00028743
    Participation: Not limited
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 31, 2001 Closing Date: June 29, 2005



    		Permanently Closed

    Head And Neck

    IDStudy TitleStatus
    HN13

    A Phase III Randomized Controlled Trial Comparing Palliative Stereotactic Body Radiotherapy vs. Palliative Standard Radiotherapy in Patients with Advanced Head and Neck Cancer

    The usual treatment to try to cure advanced Head and Neck cancer includes surgery, a long course of radiation therapy and chemotherapy. However, some patients are unable to tolerate these treatments because of toxicity. In these cases, the usual treatment is palliative radiotherapy for symptom control. The purpose of this prospective randomized phase III trial is to determine if using SBRT (Stereotactic Body Radiation Therapy) is a better option than standard radiation therapy for this patient population. SBRT is of short duration, precise and delivers high doses of radiation to the tumour safely. It may therefore provide better cancer control in this group of Head and Neck patients compared to the current standard radiotherapy.

    A Phase III Randomized Controlled Trial Comparing Palliative Stereotactic Body Radiotherapy vs. Palliative Standard Radiotherapy in Patients with Advanced Head and Neck Cancer

    Complexity Level: 1

    Eligibility: Histologically confirmed mucosal squamous cell carcinoma (SCC) of the head and neck arising from at least one of the following sites: oro/hypopharynx, oral cavity, supraglottic larynx, maxillary sinus, nasal cavity, or unknown primary. Stages TX or T0-T4/N0-N3. Must be considered unfit for curative intent RT as determined by the treating oncologist(s). Geriatric 8 score <=14. 18+. Appropriate candidate for protocol radiotherapy. CT or MRI of the head and neck within 8 weeks prior to randomization. Chest CT or x-ray within 8 weeks prior to randomization. PET CT is permitted if CT is of diagnostic quality. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-3. Patients with a prior malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational treatment are eligible for this trial.

    Objectives: Primary Objective: To compare overall survival (OS) in participants with advanced head and neck cancer who receive palliative stereotactic body radiotherapy (SBRT) compared to palliative standard RT (SRT). Secondary Objectives: Progression Free Survival, Local Regional Failure Free Survival, Distant Metastases Free Survival, Response Rate (CR, PR, SD), Acute and long-term toxicity (CTC AE version 5.0), Treatment compliance, Patient-reported Outcomes (PROCTC-AE, FACT-HN), Resource utilization and health utilities. Tertiary Objectives: Compare OS in participants by ethnic or cultural origin, Determine if differences in OS (if any) are associated with social determinants of health, Identification and assessment of prognostic biomarkers from diagnostic or planning scans, archival tumour, and baseline blood samples.

    NCT Registration ID (from clinicaltrials.gov): NCT06641791
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: CCTG Led Trial
    Status: Open to Accrual
    Activation Date: October 31, 2024



    		Open to Accrual
    HN11 (HN.11)

    SPECT-CT Guided ELEctive Contralateral Neck Treatment (Select) for Patients with Lateralized Oropharyngeal Cancer. A Phase III Randomized Controlled Trial

    This study is being done to answer the following question: Is both the chance of the cancer spreading or returning the same if radiotherapy to the neck is guided by using a special imaging study called lymph node mapping (lymphatic mapping) Single Photon Emission Computed Tomography (SPECT-CT) compared to the usual treatment when radiotherapy is given to both sides of the neck? We are doing this study because we want to find out if this approach is better or worse than the usual approach in controlling the cancer and has fewer side effects and better quality of life.

    SPECT-CT Guided ELEctive Contralateral Neck Treatment (Select) for Patients with Lateralized Oropharyngeal Cancer. A Phase III Randomized Controlled Trial

    Complexity Level: 1

    Eligibility: Patients with pathologically proven diagnosis of lateralized OPC (tonsil, tongue base, soft palate, or pharyngeal wall) not involving or crossing midline; HPV positive or negative (by p16 immunohistochemistry); Clinical stage T1-3 M0 (UICC/AJCC TNM 8th Edition); Nodal disease may include no nodes or single or multiple ipsilateral lymph nodes (largest should be less than 6 cm in maximum diameter); Planned definitive RT or CRT with bilateral neck RT (patients planned for unilateral neck RT are excluded); Must be willing to complete quality of life questionnaires.

    Objectives: Primary: To determine if a lymphatic mapping-guided approach (experimental arm) for management of the contralateral neck has a non-inferior disease-free survival (DFS) compared to bilateral neck RT (control arm) in patients with lateralized OPC not involving or crossing the midline and without clinical contralateral nodal disease. Secondary: To compare between arms the following: swallowing-related and xerostomia quality of life (QOL); isolated contralateral neck failure, overall survival, loco-regional failure, distant metastasis; RT-related toxicities, patient reported toxicities, gastrostomy tube usage, economic analyses. Exploratory: swallowing function using videofluoroscopy (sub study); Head and Neck QOL; patterns of lymphatic drainage; predicting contralateral lymphatic drainage on SPECT-CT; to correlate baseline tumor somatic mutations with recurrence; to correlate circulating cell free DNA (cfDNA) with clinical recurrence after treatment.

    NCT Registration ID (from clinicaltrials.gov): NCT05451004
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Open to Accrual
    Activation Date: September 29, 2022



    		Open to Accrual
    HNC2 (NRG HN004)

    Randomized Phase II/III Trial of Radiotherapy with Concurrent MEDI4736 (Durvalumab) vs Radiotherapy with Concurrent Cetuximab in Patients with Stage III-IVB Head and Neck Cancer with a Contraindication to Cisplatin


    Randomized Phase II/III Trial of Radiotherapy with Concurrent MEDI4736 (Durvalumab) vs Radiotherapy with Concurrent Cetuximab in Patients with Stage III-IVB Head and Neck Cancer with a Contraindication to Cisplatin

    Complexity Level: 2

    Eligibility: Eligibility Criteria include: p16 and PD-L1 status by submission of tissue samples, pathologically confirmed, previously untreated, unresected squamous cell carcinoma of larynx, hypopharynx, oropharynx, oral cavity or unknown head and neck primary within 60 days of registration (locoregionally advanced HNSCC), contraindication to cisplatin, adequate hematological hepatic and renal function, negative pregnancy test (if applicable)

    Objectives: Phase II: Primary objective is PFS. Phase III: Primary objective is OS. Secondary objectives include: Toxicity profile, effects of anti-PD-L1 therapy, OS, response, loco-regional failure, distant metastasis, and competing mortality, Quality of Life, swallowing related QoL and performance, gastronomy tube retention Exploratory objectives include: immune response, short term QoL, short term swallowing related QoL, patient reported fatigue, and health utilities

    NCT Registration ID (from clinicaltrials.gov): NCT03258554
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: May 10, 2019 Closing Date: September 01, 2022



    		Closed to Accrual
    HN9

    Randomized Phase II Study of Cisplatin plus Radiotherapy versus Durvalumab plus Radiotherapy followed by Adjuvant Durvalumab versus Durvalumab plus Radiotherapy followed by Adjuvant Tremelimumab and Durvalumab in Intermediate Risk HPV-Positive Locoregionally Advanced Oropharyngeal Squamous Cell Cancer (LA-OSCC)


    Randomized Phase II Study of Cisplatin plus Radiotherapy versus Durvalumab plus Radiotherapy followed by Adjuvant Durvalumab versus Durvalumab plus Radiotherapy followed by Adjuvant Tremelimumab and Durvalumab in Intermediate Risk HPV-Positive Locoregionally Advanced Oropharyngeal Squamous Cell Cancer (LA-OSCC)

    Complexity Level: 2

    Eligibility: 1) Histologically and/or cytologically confirmed (primary lesion or regional lymph nodes) squamous cell carcinoma of the oropharynx (OSCC) which is locoregionally advanced, intermediate risk and non-metastatic (M0) as defined by the following: - T1-2 N1 (smoking >10 pack-years) - T3 N0-N1 (smoking >10 pack-years) - T1-3 N2 (any smoking history) 2) Human papillomavirus (HPV)-related as determined by positive p16 immunohistochemical staining on any tumoural specimens. 3) Performance status of 0 or 1. 4) > 18 years of age. 5) Patient must consent to release of tumour tissue, blood, saliva and throat swab samples for correlative studies. 6) Adequate normal organ and marrow function.

    Objectives: Primary: To estimate the efficacy (in terms of event-free survival) of 3 treatment Arms: (A) radiotherapy (RT) and cisplatin; (B) RT and durvalumab followed by adjuvant durvalumab; and (C) RT and durvalumab followed by adjuvant durvalumab and tremelimumab in patients with intermediate risk, HPV-positive, locally advanced oropharyngeal squamous cell carcinoma of the head and neck (LA-OSCC). Secondary: 1) To assess differences between arms in change in FACT-HN score from baseline to 36 months post-RT; 2) To estimate and describe the following in each of the 3 treatment arms: Locoregional control; Distant metastasis-free survival (DMFS); OS; Toxicity; Incidence of second cancer; Dysphagia; PRO-CTCAE Radiation related late toxicity; Cost effectiveness; Cost utility; and lost productivity. Tertiary: 1) Correlative Studies; 2) Event-free survival as defined by iRECIST.

    NCT Registration ID (from clinicaltrials.gov): NCT03410615
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Closed to Accrual
    Activation Date: January 31, 2018 Closing Date: November 16, 2022



    		Closed to Accrual
    HN10

    A Phase II Single Arm Trial of Elective Volume Adjusted De-Escalation Radiotherapy (EVADER) in Patients with Low-risk HPV-related Oropharyngeal Squamous Cell Carcinoma


    A Phase II Single Arm Trial of Elective Volume Adjusted De-Escalation Radiotherapy (EVADER) in Patients with Low-risk HPV-related Oropharyngeal Squamous Cell Carcinoma

    Complexity Level: 2

    Eligibility: Patients with pathologically proven diagnosis of HPV-related OPSCC. Clinical stage T1-3 N0-1 M0. Patients must be eligible for definitive RT or CRT, >= 18 years of age, ECOG 0-2. Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaires in either English or French. Patients must be accessible for treatment and follow up.

    Objectives: Primary Objective: To evaluate the efficacy of primary definitive radiotherapy (RT) or chemoradiotherapy (CRT) utilizing volume reduced elective nodal irradiation (ENI) as measured by 2-year progression-free survival (PFS) in patients with low-risk HPV-related OPSCC. Secondary Objectives: To evaluate other metrics for efficacy and safety, early and late toxicities of treatment, objective swallowing and salivary functions, quality of life (QOL), utilization of healthcare resources, work productivity, and prognostic biomarkers. Tertiary Objectives: To assemble an imaging and biospecimen bank for future research that could improve risk stratification and patient selection for volume-reduced ENI.

    NCT Registration ID (from clinicaltrials.gov): NCT03822897
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: CCTG Led Trial
    Status: Closed to Accrual
    Activation Date: February 20, 2019 Closing Date: December 02, 2021



    		Closed to Accrual
    HN1

    A Phase III Study Evaluating the Role of Elective Neck Dissection in the Management of Oral Carcinoma


    A Phase III Study Evaluating the Role of Elective Neck Dissection in the Management of Oral Carcinoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: October 17, 1995 Closing Date: May 08, 1998



    		Permanently Closed
    HN5

    A Phase I Study of Adjuvant OSI-774 (Tarceva) in Patients Following Combined Chemo-Radiotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck


    A Phase I Study of Adjuvant OSI-774 (Tarceva) in Patients Following Combined Chemo-Radiotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck

    Eligibility: Patients with locally advanced squamous cell carcinoma of the head and neck (stages III, IVA or IVB) post treatment with combined chemo-radiotherapy (cisplatin based). Patients must have no evidence of disease or presence of inoperable minimal residual disease at the time of registration.

    Objectives: To evaluate the toxicity and determine the recommended dose of OSI-774. To evaluate the effect(s) of OSI-774 on plasma and urinary angiogenic factors (specifically VEGF, VEGFR, VEGFR2, bFGF levels) before, during and after therapy. To correlate angiogenic factor levels with initial blood vessel concentration in the tumour and with the presence or absence of EGFRvIII mutation. To document disease free survival (DFS).

    NCT Registration ID (from clinicaltrials.gov): NCT00079053
    Participation: Limited to invited centres only.
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: November 05, 2003 Closing Date: March 31, 2008



    		Permanently Closed
    HN6

    A Phase III Study Of Standard Fractionation Radiotherapy With Concurrent High-Dose Cisplatin Versus Accelerated Fractionation Radiotherapy With Panitumumab In Patients With Locally Advanced Stage III And IV Squamous Cell Carcinoma Of The Head And Neck.


    A Phase III Study Of Standard Fractionation Radiotherapy With Concurrent High-Dose Cisplatin Versus Accelerated Fractionation Radiotherapy With Panitumumab In Patients With Locally Advanced Stage III And IV Squamous Cell Carcinoma Of The Head And Neck.

    Complexity Level: 1

    Eligibility: Patients with histologically confirmed squamous cell carcinoma of the head and neck of the oral cavity, oropharynx, larynx or hypopharynx which is locally advanced as defined by TanyN+M0 or T3-4N0M0.

    Objectives: The primary objective is progression free survival. The secondary objectives include: overall survival, local progression free survival, regional progression free survival, distant metastasis, acute and late adverse events, quality of life, swallowing related quality of life, functional swallowing outcome (selected centres), significance of tissue and blood biomarkers, and health economics.

    NCT Registration ID (from clinicaltrials.gov): NCT00820248
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: December 18, 2008 Closing Date: November 07, 2011



    		Permanently Closed
    HN4

    A Phase II Study of Cisplatin and Gemcitabine in Patients with Locally Advanced/Recurrent or Metastatic Malignant Salivary Gland Tumours


    A Phase II Study of Cisplatin and Gemcitabine in Patients with Locally Advanced/Recurrent or Metastatic Malignant Salivary Gland Tumours

    Eligibility: Patients will have documented evidence of locally advanced recurrent and/or metastatic malignant salivary gland tumours deemed to be incurable by surgery or radiation. Patients may have had up to one prior chemotherapy regimen for locally advanced recurrent/metastatic disease provided that it was non cisplatin/carboplatin or gemcitabine containing and at least 4 weeks have elapsed since chemotherapy discontinuation and study registration. Adjuvant chemotherapy (including cisplatin or carboplatin based regimens) is allowed provided that a minimum of 12 months has elapsed.

    Objectives: Primary: To estimate the activity of combination cisplatin (or carboplatin) and gemcitabine among patients with malignant salivary gland tumours which are locally recurrent or metastatic. Secondary: Measurement of complete response Measurement of duration of response Assessment of the toxicity profile of the combination regimen Measurement of overall survival

    NCT Registration ID (from clinicaltrials.gov): NCT00079079
    Participation: Limited to invited centres only.
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: October 23, 2003 Closing Date: May 05, 2008



    		Permanently Closed
    HN2

    A Double-Blind Phase III Randomized Study of Bacitracin, Clotrimazole, Gentamicin (Bcog) Lozenges versus Placebo Lozenges for Radiation-Associated Mucositis in Head and Neck Cancer


    A Double-Blind Phase III Randomized Study of Bacitracin, Clotrimazole, Gentamicin (Bcog) Lozenges versus Placebo Lozenges for Radiation-Associated Mucositis in Head and Neck Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: September 22, 1997 Closing Date: July 30, 1999



    		Permanently Closed
    HN3

    A Comparison of Acute Oral Mucositis Between Morning and Afternoon Radiotherapy in Patients Receiving Radiation Treatment for Cancer of the Head and Neck


    A Comparison of Acute Oral Mucositis Between Morning and Afternoon Radiotherapy in Patients Receiving Radiation Treatment for Cancer of the Head and Neck

    Eligibility: Patients with squamous cell carcinoma of the oral cavity, pharynx (oro, hypo and naso), or larynx, who are to receive radiation treatment to a significant part of the oral and/or pharyngeal mucosa where the reaction will be visible.

    Objectives: To compare the toxicity of radiotherapy to the oral mucosa delivered in the morning and the late afternoon; to compare grades and duration of mucositis, incidence of clinically significant mucositis using a validated mucositis scoring system, treatment days lost because of treatment reactions, incidence of late toxicity, changes in body weight, complete response rates, survival and quality of life.

    NCT Registration ID (from clinicaltrials.gov): NCT00004234
    Participation: Not limited
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 02, 1999 Closing Date: November 15, 2004



    		Permanently Closed

    Hematologic

    IDStudy TitleStatus
    ALC9 (MM2YA-EA01)

    Eradicating Minimal Residual Disease in patients with AML prior to Stem Cell Transplant (ERASE): A MyeloMATCH Treatment Trial


    Eradicating Minimal Residual Disease in patients with AML prior to Stem Cell Transplant (ERASE): A MyeloMATCH Treatment Trial

    Complexity Level: 1

    Eligibility: - Must register to the Master Screening and Re-assessment Protocol, myeloMATCH MSRP, and be assigned to ALC.9 prior to registration. - Must have completed induction chemotherapy in a MyeloMATCH Young Adult Tier-1 protocol. - Must have attained CR or CRh with detectable MRD, as assessed by MDNet. - Must have morphologically documented AML or secondary AML (from prior conditions such as MDS, MPN), or therapy-related AML. - Must not have FLT3 TKD or ITD mutation. - Ages 18-59, ECOG performance status 0-2. - Adequate organ and marrow function (ANC >= 500/mcL; Platelets >= 50,000 mcL; creatinine <= 1.5 x ULN 30 mL/min; AST/ALT <= 3 x ULN; total bilirubin <= 2 x ULN).

    Objectives: Primary: To improve the rate of MRD negative CR in patients with AML who achieved MRD positive CR after induction chemotherapy in a myeloMATCH Young Adult Tier-1 protocol.

    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Planned



    		Planned
    MD1 (MD.1)

    CALMS: Combination Therapy with Luspatercept in Lower Risk MDS: A Non-Comparative, Parallel, Multi-Arm Phase 2 Study: A myeloMATCH Treatment Trial


    CALMS: Combination Therapy with Luspatercept in Lower Risk MDS: A Non-Comparative, Parallel, Multi-Arm Phase 2 Study: A myeloMATCH Treatment Trial

    Complexity Level: 2

    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Planned



    		Planned
    MYC2 (SWOG S1803)

    A Phase III Study of Daratumumab/rHuPH20 (NSC- 810307) + Lenalidomide or Lenalidomide as Post-Autologous Stem Cell Transplant Maintenance Therapy in Patients with Multiple Myeloma (MM) Using Minimal Residual Disease to Direct Therapy Duration (DRAMMATIC Study)

    Testing the addition of a new drug, subcutaneous daratumumab, to the usual treatment (lenalidomide) as post-stem cell transplant treatment for multiple myeloma

    A Phase III Study of Daratumumab/rHuPH20 (NSC- 810307) + Lenalidomide or Lenalidomide as Post-Autologous Stem Cell Transplant Maintenance Therapy in Patients with Multiple Myeloma (MM) Using Minimal Residual Disease to Direct Therapy Duration (DRAMMATIC Study)

    Complexity Level: 2

    Eligibility: STEP 1 (Study Entry) - (1) Confirmed diagnosis of symptomatic multiple myeloma that required systemic induction therapy prior to stem cell transplant (ASCT). (2) No organ involvement by amyloidosis or evidence of amyloidosis related organ dysfunction. (3) No prior progressive disease. (4) Refractory to or intolerant to either lenalidomide or daratumumab/rHuPH20 (5) Must have initiated induction therapy within 12mo prior to reg Step 1 (at least 2 cycles therapy). (6) over 18 under 75 years of age, physical exam, Zubrod 2 or less, adequate renal and liver function (7) mandatory had/will have standard stem cell transplant (8) - STEP 2 (Rand 1: Post ASCT/Pre-Maintenance) - (1) ASCT within 180 days and no maintenance therapy and no progressive disease (2) scan for disease assessment (3) adequate hepatic and renal function - STEP 3 (Rand 2: post 2yr main) (1) completed 24 cycles of maintenance lenalidomide or lenalidomide+dara (2) be 24mo MRD neg in very good partial remission.

    Objectives: Primary objective: To compare overall survival (OS) between the two treatment arms with lenalidomide as the comparator arm and lenalidomide + daratumumab/rHuPH20 as the experimental arm in post-autologous transplant multiple myeloma (MM) patients. Secondary objectives: Overall Response Rate (ORR), Progression-Free Survival (PFS), Evaluate MRD-negativity between arms, compare toxicity and tolerability of long term therapy between arms. Compare OS between MRD negative patients between groups. Additional objectives: To report the findings of the 24-month MRD analysis as early as 24 months after all patients have been accrued.

    NCT Registration ID (from clinicaltrials.gov): NCT04071457
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Open to Accrual
    Activation Date: April 11, 2022



    		Open to Accrual
    AL6 (MM1YA-CTG01)

    A Measurable Residual Disease (MRD) Focused, Phase II Study of Venetoclax Plus Chemotherapy for Newly Diagnosed Younger Patients with Intermediate Risk Acute Myeloid Leukemia: A Tier 1 MYELOMATCH Clinical Trial

    Patients with previously untreated intermediate risk acute myeloid leukemia(AML) will receive either cytarabine+ daunorubicin+venetoclax or azactidine +venetoclax or cyctarabine+daunorubicin to determine which treatment results in complete responses in the highest percentage of patients.

    A Measurable Residual Disease (MRD) Focused, Phase II Study of Venetoclax Plus Chemotherapy for Newly Diagnosed Younger Patients with Intermediate Risk Acute Myeloid Leukemia: A Tier 1 MYELOMATCH Clinical Trial

    Complexity Level: 2

    Eligibility: Participants must have been registered to Master Screening and Re-Assessment Protocol (ALC.7-myeloMATCH MSRP) and assigned to this trial via MATCHBox prior to consenting to this study. Previously untreated, de novo AML defined by >20% myeloblasts in the peripheral blood or bone marrow excluding the following: favorable cytogenetics; CEBPA biallelic mutations; NPM1 mutation; AML with PML-RARa; AML with any adverse cytogenetics, TP53 mutation, RUNX1 mutation, ASXL1,11q23/KMT2 rearrangements; AML with FLT3-ITD or FLT3-TKD mutations; therapy related AML, or AML following a diagnosis of myelodysplasia or myeloproliferative neoplasm - Age 18-59 at the time of induction therapy, ECOG performance status<= 3

    Objectives: Primary: Compare the rates of undetectable MRD in patients who acheive a CR after induction therapy between the 7+3, 7+3+venetoclax and venetoclax+azacitidine Secondary: To estimate the frequency and severity of toxcities with each of the regimens To estimate CR and CRi rates(with or without MRD), EFS, RFS and OS in each regimen. Tertiary: Evaluate response to therapy received according to genomic findings. Evaluate MRD kinetics by following patients with detectable MRD through Tier 2 and beyond. - Evaluate longer term outcomes by treatment arm, genomics, MRD outcome and other features as patients receive additional myeloMatch therapies

    NCT Registration ID (from clinicaltrials.gov): NCT05554393
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Open to Accrual
    Activation Date: July 18, 2024



    		Open to Accrual
    MY13

    A Phase III Non-Inferiority Randomized Controlled Trial of Fixed Duration versus Continuous Daratumumab Among Transplant Ineligible Older Adults with Newly Diagnosed Multiple Myeloma

    This randomized phase III trial studies whether daratumumab treatment can end once myeloma patients have received its maximum benefit without reducing disease control provided by their remaining treatment.

    A Phase III Non-Inferiority Randomized Controlled Trial of Fixed Duration versus Continuous Daratumumab Among Transplant Ineligible Older Adults with Newly Diagnosed Multiple Myeloma

    Complexity Level: 2

    Eligibility: Newly-diagnosed, transplant ineligible multiple myeloma, meets measurable disease criteria (Serum M-protein >=5 g/L; urine M-protein >=200 mg/24 hrs; if abnormal serum free light chain ratio, serum free light chain >=100 mg/L; for IgA patients, qIgA >=750 mg/dL), received daratumumab-lenalidomide-dexamethasone (dara-len-dex) for 18-20 cycles with >=partial response per IMWG criteria, ECOG performance status 0-3.

    Objectives: Primary objective is to evaluate non-inferiority in progression-free survival for fixed versus continuous duration dara in patients already receiving dara-len-dex treatment. Secondary objectives: Comparing between fixed and continuous duration dara arms i) overall survival, ii) proportion of patients with a very good partial response to treatment or better, iii) the incidence of treatment-related grade 3 through 5 adverse events, iv) the time to next treatment, v) post protocol therapy, vi) quality of life, and vii) health economics

    NCT Registration ID (from clinicaltrials.gov): NCT06182774
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: CCTG Led Trial
    Status: Open to Accrual
    Activation Date: December 08, 2023



    		Open to Accrual
    LY18

    A Phase I Master Protocol of Novel Combination Therapy for Patients with Relapsed or Refractory Aggressive B-Cell Lymphoma

    This is an unblinded (open-label) multi-centre phase I trial of novel combination therapy in patients with relapsed and refractory aggressive B cell lymphoma, conducted by the CCTG. The study will open with one cohort. Additional cohorts may be added in future as separate appendices, through protocol amendment. There will be no randomization.

    A Phase I Master Protocol of Novel Combination Therapy for Patients with Relapsed or Refractory Aggressive B-Cell Lymphoma

    Complexity Level: 2

    Eligibility: Patients with relapsed and refractory aggressive B cell lymphoma (includes diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, and T-cell rich B-cell lymphoma, as well as previous indolent lymphoma with transformation to diffuse large B-cell lymphoma at most recent relapse, with clinically and/or radiologically measureable disease. Patients with de novo aggressive B-cell lymphoma must have relapsed or progressed, or have biopsy proven refractory disease, after one prior line of therapy (R-CHOP chemotherapy or equivalent). Patients with histological transformation from low-grade lymphoma may have had up to 3 prior treatment regimens. Patients with transformed low grade lymphoma treated with a non-anthracycline regimen may be enrolled at investigator discretion Patients must be 16 years old or older, must be an appropriate candidate to receive second-line salvage chemotherapy, and must be considered fit for intensive chemotherapy and ASCT.

    Objectives: The primary objective is to establish the recommended phase II dose of new combination therapy in individuals with relapsed and refractory lymphoma. Secondary objectives include determining the overall response rate using RECIL and Lugano response criteria, evaluating the tolerability and toxicity, determining the stem cell collection rate and transplantation rate, and determine overall survival and event free survival. An exploratory objective is to assess molecular factors, which may be prognostic or predictive of response.

    NCT Registration ID (from clinicaltrials.gov): NCT04161248
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Open to Accrual
    Activation Date: December 06, 2019



    		Open to Accrual
    HD12 (RADAR)

    A Randomized Phase III Trial with a PET Response Adapted Design Comparing ABVD +/- ISRT with A2VD +/- ISRT in Patients with Previously Untreated Stage IA/IIA Hodgkin Lymphoma (RADAR)

    The HD.12/RADAR study is for patients diagnosed with previously untreated stage IA/IIA Hodgkins Lymphoma. The purpose of the study is to answer the following question: Will replacing one of the drugs in the usual treatment with a drug called brentuximab vedotin a) improve cure rates and/or b) reduce side effects during treatment and later in life?

    A Randomized Phase III Trial with a PET Response Adapted Design Comparing ABVD +/- ISRT with A2VD +/- ISRT in Patients with Previously Untreated Stage IA/IIA Hodgkin Lymphoma (RADAR)

    Complexity Level: 2

    Eligibility: Patients, 16-69 years old and have histologically confirmed stage I or II classical Hodgkin lymphoma with no mediastinal bulk disease or B symptoms. Patients must have ECOG status of 0 to 2.with no prior treatment for Hodgkin lymphoma, but are fit to receive anthracycline-based chemotherapy. Patient must have the following lab values: creatinine clearance >40 ml/min, total bilirubin <1.5 x ULN, ALT or AST <2 x ULN, haemoglobin > or equal to 8g/dL, neutrophils > or equal to 1.0 x109/l, and platelets > or equal to 100 x109/l. Patients may not have nodular lymphocyte Hodgkin lymphoma, pre-existing grade > or equal to 1 sensory or motor peripheral neuropathy, symptomatic neurologic disease, history of progressive PML, significant cardiovasular or respiratory disease, serious active disease or co-morbid medical condition, uncontrolled active systemic infection, HIV, hepatitis C, or active hepatitis B. No other cancer (with exception), recurrent, or persistent cancer within last 5 years.

    Objectives: Primary objective: To assess whether the substitution of bleomycin (ABVD) to brentuximab vedotin (A2VD) improves progression free survival (PFS) Secondary objectives: To assess whether the substitution of bleomycin (ABVD) to brentuximab vedotin (A2VD) improves PET CMR rates To assess whether the substitution of bleomycin (ABVD) to brentuximab vedotin (A2VD) improves event-free survival (EFS) To assess whether the substitution of bleomycin (ABVD) to brentuximab vedotin (A2VD) has an effect on overall survival (OS)

    NCT Registration ID (from clinicaltrials.gov): NCT04685616
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Open to Accrual
    Activation Date: August 08, 2023



    		Open to Accrual
    HD11

    A Randomized Phase II Trial of Pembrolizumab and Brentuximab Vedotin versus GDP Followed by High Dose Chemotherapy and Autologous Stem Cell Transplantation for Relapsed/Refractory Classical Hodgkin Lymphoma

    This is an open label, multi-centre, randomized phase II trial of novel combination therapy followed by autologous stem cell transplantation in patients with relapsed and refractory classical Hodgkin lymphoma, conducted by the CCTG with support of Merck and Seattle Genetics. The trial will compare standard gemcitabine, dexamethasone, and cisplatin (GDP) versus pembrolizumab and brentuximab as salvage therapy prior to transplant. FDG-PET review performed locally to assess response and then central review to be performed at the end of study

    A Randomized Phase II Trial of Pembrolizumab and Brentuximab Vedotin versus GDP Followed by High Dose Chemotherapy and Autologous Stem Cell Transplantation for Relapsed/Refractory Classical Hodgkin Lymphoma

    Complexity Level: 2

    Eligibility: Patients 18 years and up must have had a history of classic Hodgkin lymphoma by histopathology and have relapsed or refractory disease after anthracycline-containing chemotherapy. Patients must have ECOG performance of 0-1 and are eligible for high dose chemotherapy and autologous stem cell transplant. No prior salvage systemic therapy for relapsed/refractory disease. No history of peripheral neuropathy or dyspnea > grade 2, active CNS disease, cerebral vascular event, progressive multifocal leukoencephalopathy (PML), (non-infectious) pneumonitis requiring steroids, HIV, nor other malignancies (with exceptions). No diagnosis of immunodeficiency, no active autoimmune disease requiring treatment in past 3 years. No active Hepatitis C or B infection or any uncontrolled active systemic infection. No clinically significant cardiovascular disease. Any serious active disease or co-morbid medical condition. No live vaccination. No allogenic tissue/solid organ transplant. No RT within 14 days.

    Objectives: Primary:To determine the complete response rate by PET Deauville criteria (score 1-3) of pembrolizumab and brentuximab vedotin compared to standard GDP (gemcitabine, dexamethasone, cisplatin) given as salvage therapy. Secondary: PFS, EFS, OS, successful stem cell collection rate, transplantation rate, toxicity and safety, patient reported quality of life, health economics including patient reported financial toxicity and cost per quality adjusted life years Exploratory: To identify markers of disease response and/or tumour biology that provide prognostic or predictive information, to evaluate PET radiomic parameters beyond those identified in the Lugano 2014 response criteria, and to evaluate response and outcome using the RECIL and LYRIC criteria

    NCT Registration ID (from clinicaltrials.gov): NCT05180097
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Open to Accrual
    Activation Date: March 03, 2022



    		Open to Accrual
    CLC3E

    An Economic Analysis of Early vs Delayed Therapy in Newly Diagnosed Asymptomatic High-Risk Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma: A Companion Analysis to CCTG CLC.3/SWOG 1925 Randomized Phase III Clinical Trial

    This study is investigating the cost-utility ratio between the early approach and delayedd approach arms of the CLC.3 main study for a Canadian health care perspective.

    An Economic Analysis of Early vs Delayed Therapy in Newly Diagnosed Asymptomatic High-Risk Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma: A Companion Analysis to CCTG CLC.3/SWOG 1925 Randomized Phase III Clinical Trial

    Complexity Level: 3

    Eligibility: Participants who are eligible for the core CLC.3 study are eligible and included in the CLC.3E sub-study

    Objectives: Primary: To determine the incremental cost-utility ratio of an early novel therapy approach (venetoclax-obinutuzumab) compared to a deferred approach in Canadian patients with high-risk CLL. Direct medical costs will be estimated from the perspective of the Canadian public healthcare system. The denominator of the ratio will be expressed in quality-adjusted life years gained. Secondary: To determine the incremental cost-effectiveness ratio of an early novel therapy approach compared to a deferred approach in Canadian patients with high-risk CLL (enrolled in the randomized component of the SWOG S1925/CLC3 study). Effectiveness will be expressed in life years gained and years to second progression gained. To determine direct medical costs of care, to compare change in health preference (utility) over time, and to compare the lost productivity for Canadian individuals with high-risk CLL.

    NCT Registration ID (from clinicaltrials.gov): NCT05371808
    Participation: Limited to invited centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: CCTG Led Trial
    Status: Open to Accrual
    Activation Date: May 10, 2022



    		Open to Accrual
    CLC3 (SWOG S1925)

    Randomized Phase III Study of Early Intervention with Venetoclax and Obinutuzumab versus DeLayed Therapy with VEnetoclax and Obinutuzumab in Newly Diagnosed Asymptomatic High-Risk Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL): EVOLVE CLL/SLL Study


    Randomized Phase III Study of Early Intervention with Venetoclax and Obinutuzumab versus DeLayed Therapy with VEnetoclax and Obinutuzumab in Newly Diagnosed Asymptomatic High-Risk Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL): EVOLVE CLL/SLL Study

    Complexity Level: 2

    Eligibility: Confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) diagnosed withing 12 months prior to registration. Must have CLL-International Prognostic Index Score greater or equal to 4 and/or complex cytogenics. Cytogenic and FISH analyses within 12 months prior to registration. TP53 mutation status if done completed within 12 months prior to registration. IgVH status obtained prior to registration. Serum beta-2 microglobulin level obtained within 28 days prior to registration. Must not meet any of the IWCLL specified criteria for active CLL therapy.

    Objectives: Primary: To evaluate whether early treatment with venetoclax and obinutuzumab (V-O) extends overall survival (OS) compared with delayed treatment with V-O in high-risk (chronic lymphocytic leukemia [CLL] international prognostic indicator [CLL-IPI] .4 or complex cytogenetics), newly diagnosed asymptomatic CLL/SLL patients. Secondary: Compare overall response rate between arms. To evaluate safety and tolerability of each arm. To compare time to second CLL-directed treatment between arms. To compare relapse-free survival (RFS) and time to second objective disease response. To compare rates of Richter's transformation between arms. To describe Cumulative Illness Rating Scale across the study, in each treatment arm and to estimate the interaction between the scale and treatment and OS. Teritary: To assess impact of early intervention with V-O versus delayed therapy with V-O in CLL patients to HRQoL using FACT-Leukemia. Additional correlative objectives

    NCT Registration ID (from clinicaltrials.gov): NCT04269902
    Participation: Limited to invited centres; Site Selection Open
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Open to Accrual
    Activation Date: December 23, 2021



    		Open to Accrual
    ALC8 (MM1YA-S01)

    A Randomized Phase II Study Comparing Cytarabine + Daunorubicin (7+3) VS (Daunorubicin and Cytarabine) Liposome, Cytarabine + Daunorubicin + Venetoclax, Azacitidine + Venetoclax, and (Daunorubicin and Cytarabine) Liposome + Venetoclax in Patients Aged 59 or Younger who are Considered High-Risk (Adverse) Acute Myeloid Leukemia as Determined by myeloMATCH; A MYELOMATCH Clinical Trial

    Patients with untreated high-risk acute myeloid leukemia (AML) will receive either (1) cytarabine + daunorubicin, (2) cytarabine + daunorubicin + venetoclax, (3) azacitidine + venetoclax, (4) (cytarabine and daunorubicin) liposome, or (5) (cytarabine and daunorubicin) liposome + venetoclax to compare the rates of complete remission between treatments.

    A Randomized Phase II Study Comparing Cytarabine + Daunorubicin (7+3) VS (Daunorubicin and Cytarabine) Liposome, Cytarabine + Daunorubicin + Venetoclax, Azacitidine + Venetoclax, and (Daunorubicin and Cytarabine) Liposome + Venetoclax in Patients Aged 59 or Younger who are Considered High-Risk (Adverse) Acute Myeloid Leukemia as Determined by myeloMATCH; A MYELOMATCH Clinical Trial

    Complexity Level: 1

    Eligibility: -Must register to the Master Screening and Re-assessment Protocol, myeloMATCH MSRP. and be assigned to ALC.8 prior to registration. -Must have newly diagnosed, untreated AML. -Must have high-risk AML per ELN 2017 criteria. Participants with t-AML, AML evolving from an antecedent hemotologic disorder, or AML-MRC are eligible. Acute promyelocytic leukemia is excluded. -Participants with FLT3 mutations and t(9;22) translocation are excluded. -Ages 18-59, Zubrod Performance Status <= 3. -Adequate organ function (creatinine clearance >= 30 mL/min; AST/ALT < 3 x ULN; total bilirubin <= 2 x ULN; cardiac ejection function >= 50%)

    Objectives: ,Primary: Compare rates of measureable residual disease (MRD) negative complete remission between (1) cytarabine + daunorubicin, (2) cytarabine + daunorubicin + venetoclax, (3) azacitidine + venetoclax, (4) (cytarabine and daunorubicin) liposome and (5) (cytarabine and daunorubicin) liposome + venetoclax. Secondary: Estimate the frequency and severity of toxicities with each regimen. -Estimate CR, CRi with and without MRD, EFS, time to relapse, RFS, and OS in each regimen. -Describe and compare MRD negative CR rates by genomic subgroups within and across randomized arms. Banking: Bank specimens for future correlative studies.

    NCT Registration ID (from clinicaltrials.gov): NCT05554406
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Open to Accrual
    Activation Date: September 25, 2024



    		Open to Accrual
    ALC7 (MYELOMATCH)

    MYELOMATCH, Master Screening and Reassessment Protocol (MSRP) for Tier Advancement in the NCI MYELOMATCH Clinical Trials

    This screening study involves testing bone marrow and blood of participants with AML or MDS for certain biomarkers that specific drugs can target. The biomarker testing will show if participants can be assigned to a myeloMATCH treatment study or can be assign to receive standard of care (SOC) treatment under the care of their doctor. Each myeloMATCH treatment study is a clinical trial that tests treatment for myeloid cancer.

    MYELOMATCH, Master Screening and Reassessment Protocol (MSRP) for Tier Advancement in the NCI MYELOMATCH Clinical Trials

    Complexity Level: 3

    Eligibility: Participants must be ≥ 18 years of age and be suspected to have previously untreated acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). For participants assigned an AML basket protocol, there cannot be a history of previous myeloproliferative neoplasms (MPN) or MDS. No have a prior or concurrent malignancy that requires concurrent anti-cancer therapy. Participants must have agreed to specimens submitted and offered the opportunity to participate in banking.

    Objectives: Primary: a.Screening and Reassessment (MSRP): To evaluate the feasibility of MATCHBox receiving and organizing all data needed for assignment to a myeloMATCH clinical trial or Tier Advancement Pathway (TAP) within 72 hours of MDNet receipt of all required specimens for initial therapy and within 10 days for subsequent therapy. b. TAP: To enable participants who are not matched to an investigational myeloMATCH treatment substudy to receive standard of care (SOC) while remaining on the MSRP to maintain access to later tiers of treatment substudies. See protocol for secondary objectives.

    NCT Registration ID (from clinicaltrials.gov): NCT05564390
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Open to Accrual
    Activation Date: May 29, 2024



    		Open to Accrual
    ALC6 (ALLIANCE A041501)

    A Phase III Trial to Evaluate the Efficacy of the Addition of Inotuzumab Ozogamicin (A Conjugated Anti-CD22 Monoclonal Antibody) to Frontline Therapy in Young Adults (Ages 18-39 Years) with Newly Diagnosed Precursor B-Cell ALL


    A Phase III Trial to Evaluate the Efficacy of the Addition of Inotuzumab Ozogamicin (A Conjugated Anti-CD22 Monoclonal Antibody) to Frontline Therapy in Young Adults (Ages 18-39 Years) with Newly Diagnosed Precursor B-Cell ALL

    Complexity Level: 1

    Eligibility: Patients who are 18 to 39 years old and are newly diagnosed with CD-22 positive B-cell acute lymphoblastic leukemia (WHO criteria) are eligible for this study. Patients with Burkitt type ALL or who have BCR-ABL fusion transcript determined by FISH or RT-PCR or t(9;22)(q34;q11) by cytogenetics are not eligible. No prior therapy is allowed for ALL except for limited treatment with corticosteroids or hydroxyurea and a single dose of intrathecal cytarabine. No prior therapy for acute leukemia except emergency therapy (corticosteroids or hydroxyurea) for blast cell crisis, superior vena cava syndrome, or renal failure due to leukemic infiltration of the kidneys. Patients must complete remission induction therapy and have M2 marrow or better by the time of randomization.

    Objectives: To determine whether the addition of inotuzumab ozogamicin significantly improves the event-free survival (EFS), without censoring for transplant. To determine the impact of inotuzumab ozogamicin on disease-free (DFS) and overall survival (OS) in patients who achieve an induction response.To determine whether the addition of inotuzumab ozogamicin significantly improves the event-free survival (EFS) in patients who achieve an induction response achieved, with censoring for transplant.To determine the impact of inotuzumab ozogamicin on minimal residual disease (MRD) and correlate this with the EFS, DFS and OS.To determine the prognosis based on patients' LDA gene signature. To evaluate the toxicity and tolerability of the addition of inotuzumab ozogamicin to the regimen used in CALGB 10403.

    NCT Registration ID (from clinicaltrials.gov): NCT03150693
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: On Hold
    Activation Date: April 12, 2019



    		On Hold
    LY17

    A Multi-stage Randomized Phase II Study of Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma


    A Multi-stage Randomized Phase II Study of Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma

    Complexity Level: 2

    Eligibility: Patients with relapsed and refractory aggressive B cell lymphoma (includes diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, and T-cell rich B-cell lymphoma, as well as transformed previousl indolent lymphoma and unclassifiable B-cell lymphoma), with clinically and/or radiologically measureable disease. Patients must be 16 years old or older, must have had at least one previous regimen of therapy for their disease, and must be considered fit for intensive chemotherapy and ASCT. Patients must have a life expectancy of >90 days, and a performance status of 3 or less. Specific laboratory requirements also apply.

    Objectives: To determine the overall response rate (complete and partial response) to novel combination therapy in patients with relapsed and refractory aggressive B cell lymphoma.

    NCT Registration ID (from clinicaltrials.gov): NCT02436707
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: On Hold
    Activation Date: May 05, 2015



    		On Hold
    LY16 (LYSARC RELEVANCE)

    A Phase III Open-Label Randomized Study to Compare the Efficacy and Safety of Rituximab Plus Lenalidomide (CC-5013) versus Rituximab Plus Chemotherapy Followed by Rituximab in Subjects With Previously Untreated Follicular Lymphoma


    A Phase III Open-Label Randomized Study to Compare the Efficacy and Safety of Rituximab Plus Lenalidomide (CC-5013) versus Rituximab Plus Chemotherapy Followed by Rituximab in Subjects With Previously Untreated Follicular Lymphoma

    Complexity Level: 2

    Eligibility: Investigator-assessed diagnosis of Stage II-IV CD20+ follicular lymphoma (grade 1-3a)

    Objectives: Co-Primary: complete response (CR/CRu), progression free survival (PFS) Secondary: event free survival (EFS),time to next anti-lymphoma treatment (TTNLT, overall survival (OS), safety, Exploratory: CR rate at 120 weeks and PFS, time to treatment failure (TTF), time to next chemotherapy treatment (TTNCT) and overall response rate (ORR) at 120 weeks, biomarker analysis, health related QoL and health economics.

    NCT Registration ID (from clinicaltrials.gov): NCT01650701
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: June 17, 2013 Closing Date: November 10, 2014



    		Closed to Accrual
    CLC2 (ALLIANCE A041202)

    A Randomized Phase III Study of Bendamustine plus Rituximab versus Ibrutinib plus Rituximab versus Ibrutinib Alone in Untreated Older Patients (> = to 65 years of age) with Chronic Lymphocytic Leukemia (CLL).


    A Randomized Phase III Study of Bendamustine plus Rituximab versus Ibrutinib plus Rituximab versus Ibrutinib Alone in Untreated Older Patients (> = to 65 years of age) with Chronic Lymphocytic Leukemia (CLL).

    Complexity Level: 2

    Eligibility: Intermediate or high-risk Rai stage chronic lymphocytic leukemia. Patients must be age 65 or older and have not received previous treatment for CLL.

    Objectives: To determine whether progression free survival (PFS) is superior after therapy with bendamustine in combination with rituximab, ibrutinib alone, or ibrutinib in combination with rituximab in patients age 65 or older with previously untreated CLL

    NCT Registration ID (from clinicaltrials.gov): NCT01886872
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: February 05, 2015 Closing Date: May 01, 2016



    		Closed to Accrual
    ALC4 (ECOG E1910)

    A Phase III Randomized Trial of Blinatumomab for Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia in Adults.


    A Phase III Randomized Trial of Blinatumomab for Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia in Adults.

    Complexity Level: 1

    Eligibility: Adults aged 30-70 years with confirmed new diagnosis of BCR-ABL negative, B-lineage ALL.

    Objectives: Primary: to evaluate the overall survival associated with blinatumomab Secondary: minimal residual disease assessment; toxicities associated with treatment; outcome of blood/marrow transplant with or without blinatumomab; incidence of anti-blinatumomab antibody formation

    NCT Registration ID (from clinicaltrials.gov): NCT02003222
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: March 24, 2017 Closing Date: October 15, 2019



    		Closed to Accrual
    LY12

    A Phase III Study of Gemcitabine, Dexamethasone, and Cisplatin Compared to Dexamethasone, Cytarabine, and Cisplatin Plus/Minus Rituximab [(R) -GDP VS (R) -DHAP] as Salvage Chemotherapy for Patients with Relapsed or Refractory Aggressive Histology Non-Hodgkin's Lymphoma Prior to Autologous Stem Cell Transplant and Followed by Maintenance Rituximab Versus Observation.


    A Phase III Study of Gemcitabine, Dexamethasone, and Cisplatin Compared to Dexamethasone, Cytarabine, and Cisplatin Plus/Minus Rituximab [(R) -GDP VS (R) -DHAP] as Salvage Chemotherapy for Patients with Relapsed or Refractory Aggressive Histology Non-Hodgkin's Lymphoma Prior to Autologous Stem Cell Transplant and Followed by Maintenance Rituximab Versus Observation.

    Complexity Level: 2

    Eligibility: Patients to be included are those with a diagnosis of aggressive histology (B cell or T cell) non-Hodgkin's lymphoma whose disease is refractory to or relapsed after one prior first-line, anthracycline-containing chemotherapy regimen. Patients with CD20+ve B cell disease will be further evaluated after completion of protocol salvage treatment and autologous stem cell transplant (ASCT) for randomization to either maintenance rituximab or observation alone.

    Objectives: Randomization 1, Salvage Treatment [(R)-GDP vs (R)DHAP]. Primary: to compare response rates between the two salvage groups after two cycles of either (R)-GDP or (R)-DHAP; to compare the transplntation rate of the two salvage regimens. Secondary: to compare between the two arms event-free survival and overall survival, successful mobilization rates, quality of life, toxic effects, resource utilization, and medical/societal costs. Randomization 2, Maintenance (rituximab vs observation). Primary: to compare two-year event-free survival between the two maintenance groups. Secondary: to compare between the two arms two-year overall survival and toxic effects.

    NCT Registration ID (from clinicaltrials.gov): NCT00078949
    Participation: Not limited.
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Closed to Accrual
    Activation Date: August 07, 2003 Closing Date: December 31, 2012



    		Closed to Accrual
    HDC1 (SWOG S1826)

    A Phase III Randomized Study of Nivolumab (Opdivo) or Brentuximab Vedotin (Adcetris) plus AVD in Patients (age >/= 12 Years) with Newly Diagnosed Advanced Stage Classical Hodgkin Lymphoma


    A Phase III Randomized Study of Nivolumab (Opdivo) or Brentuximab Vedotin (Adcetris) plus AVD in Patients (age >/= 12 Years) with Newly Diagnosed Advanced Stage Classical Hodgkin Lymphoma

    Complexity Level: 2

    Eligibility: All patients must have histologically confirmed newly diagnosed, previously untreated Stage III or IV classical Hodgkin lymphoma (nodular sclerosing, mixed cellularity, lymphocyte-rich, or lymphocyte-depleted, or not otherwise specified (NOS)). Nodular lymphocyte predominant Hodgkin Lymphoma is not eligible. Patients must have bidimensionally measurable disease (at least one lesion with longest diameter greater than or equal to 1.5 cm). Patients must have a whole body or limited whole body PET-CT scan performed within 42 days prior to registration. Pts. must be greater than or equal to 12 years of age.

    Objectives: Primary: To compare the PFS in patients with newly diagnosed advanced stage classical Hodgkin lymphoma randomized to N-AVD versus that obtained with BV-AVD. Secondary:To compare OS, EFS, CR in pts rand. to N-AVD vs. BV-AVD and the safety and tolerability of N-AVD vs BV-AVD. To compare physician-reported treatment related AE rates b/w arms stratified by age. To compare pt reported symptoms using selected PRO-CTCAE items between arms stratified by age.

    NCT Registration ID (from clinicaltrials.gov): NCT03907488
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: December 08, 2020 Closing Date: December 01, 2022



    		Closed to Accrual
    AL5 (DFCI 06-254)

    Dana Farber Cancer Institue (DFCI) Acute Lymphoblastic Leukemia (ALL) Adult Consortium Trial: Adult ALL Trial


    Dana Farber Cancer Institue (DFCI) Acute Lymphoblastic Leukemia (ALL) Adult Consortium Trial: Adult ALL Trial

    Complexity Level: 1

    Eligibility: Eligibility: All adults aged 18 to 50 years with newly diagnosed ALL will be eligible for this protocol. Patients with ALL-L3 will not be eligible for this study.

    Objectives: Primary: To determine the feasibility, toxicity and efficacy of the high-risk pediatric treatment regimen in adult patients 18 years of age and older. The primary endpoint of this study is the feasibility of the intensification therapy, measured as the percentage of patients who, having achieved a CR after induction therapy, receive more than 25 weeks of IV PEG asparaginase as part of intensification therapy. To explore the relative toxicity of IV PEG asparaginase. To explore the relative efficacy and toxicity of adding imatinib to multiagent chemotherapy for patients with Philadelphia-positive ALL.

    NCT Registration ID (from clinicaltrials.gov): NCT01005758
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: September 10, 2008 Closing Date: January 08, 2013



    		Closed to Accrual
    LYC1 (ECOG E1411)

    Intergroup Randomized Phase II Four Arm Study In Patients With Previously Untreated Mantle Cell Lymphoma Of Therapy With: Arm A = Rituximab+ Bendamustine Followed By Rituximab Consolidation (RB -> R); Arm B = Rituximab + Bendamustine + Bortezomib Followed By Rituximab Consolidation (RBV -> R), Arm C = Rituximab + Bendamustine Followed By Lenalidomide + Rituximab Consolidation (RB -> LR) or Arm D = Rituximab + Bendamustine + Bortezomib Followed By Lenalidomide + Rituximab Consolidation (RBV -> LR)


    Intergroup Randomized Phase II Four Arm Study In Patients With Previously Untreated Mantle Cell Lymphoma Of Therapy With: Arm A = Rituximab+ Bendamustine Followed By Rituximab Consolidation (RB -> R); Arm B = Rituximab + Bendamustine + Bortezomib Followed By Rituximab Consolidation (RBV -> R), Arm C = Rituximab + Bendamustine Followed By Lenalidomide + Rituximab Consolidation (RB -> LR) or Arm D = Rituximab + Bendamustine + Bortezomib Followed By Lenalidomide + Rituximab Consolidation (RBV -> LR)

    Complexity Level: 2

    Eligibility: Patients must have confirmed diagnosis of mantle cell lymphoma and must be greater than 18 years old.

    Objectives: Primary: progression free survival in induction and consolidation Secondary: PET document complete response rate, objective response rate, overall survival, safety

    NCT Registration ID (from clinicaltrials.gov): NCT01415752
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: March 12, 2014 Closing Date: September 09, 2016



    		Closed to Accrual
    CLC2E

    A Prospective Economic Analysis of NCIC CTG CLC.2/ALLIANCE A041202: A Randomized Phase III CLL Study of Bendamustine Plus Rituximab versus Ibrutinib Plus Rituximab versus Ibrutinib Alone in Untreated Older Patients (>= 65 Years of Age) With Chronic Lymphocytic Leukemia


    A Prospective Economic Analysis of NCIC CTG CLC.2/ALLIANCE A041202: A Randomized Phase III CLL Study of Bendamustine Plus Rituximab versus Ibrutinib Plus Rituximab versus Ibrutinib Alone in Untreated Older Patients (>= 65 Years of Age) With Chronic Lymphocytic Leukemia

    Complexity Level: 3

    Eligibility: All Canadian patients registered to CLC.2

    Objectives: To determine the incremental cost-utility ratio, as measured in cost per quality-adjusted life-years gained, of ibrutinib-containing regimens compared to bendamustine-rituximab in elderly patients with CLL (Canadian subset of patients). The primary analysis will compare ibrutinib-rituximab with bendamustine-rituximab.

    NCT Registration ID (from clinicaltrials.gov): NCT02414022
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Closed to Accrual
    Activation Date: March 13, 2015 Closing Date: May 01, 2016



    		Closed to Accrual
    HD4

    A Clinical Trial of MOPP/ABV Hybrid versus Alternating MOPP/ABVD for Advanced or Recurrent Hodgkin's Disease


    A Clinical Trial of MOPP/ABV Hybrid versus Alternating MOPP/ABVD for Advanced or Recurrent Hodgkin's Disease

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 15, 1984 Closing Date: December 29, 1989



    		Permanently Closed
    MY4

    Etidronate Disodium (EHDP) Versus Placebo in the Treatment of Multiple Myeloma


    Etidronate Disodium (EHDP) Versus Placebo in the Treatment of Multiple Myeloma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: November 19, 1983 Closing Date: February 28, 1987



    		Permanently Closed
    LY2

    Treatment of Poor Prognosis Lymphomas With Bone Marrow Involvement, Intensive BACOP Chemotherapy Under Cover of Septra Prophylaxis


    Treatment of Poor Prognosis Lymphomas With Bone Marrow Involvement, Intensive BACOP Chemotherapy Under Cover of Septra Prophylaxis

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 01, 1980 Closing Date: December 01, 1980



    		Permanently Closed
    HD2

    Comparison of Radiotherapy Alone With Radiotherapy Preceded by or Preceded and Followed by Three Courses of MOPP, With Standardized Treatment of First and Second Relapse and Incomplete Remission


    Comparison of Radiotherapy Alone With Radiotherapy Preceded by or Preceded and Followed by Three Courses of MOPP, With Standardized Treatment of First and Second Relapse and Incomplete Remission

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 14, 1977 Closing Date: June 11, 1979



    		Permanently Closed
    LY10

    A Phase II Study of Gemcitabine, Dexamethasone, and Cisplatin (GDP) in Patients With Either Hodgkin's Disease or Aggressive Histology Non-Hodgkin's Lymphoma Which is Relapsed or Refractory


    A Phase II Study of Gemcitabine, Dexamethasone, and Cisplatin (GDP) in Patients With Either Hodgkin's Disease or Aggressive Histology Non-Hodgkin's Lymphoma Which is Relapsed or Refractory

    Eligibility: Patients with a diagnosis of either Hodgkin's disease or aggressive histology non-Hodgkin's lymphoma of B-cell origin, whose disease is refractory to or relapsed after one prior chemotherapy regimen.

    Objectives: To determine the efficacy (response rates and percent of complete remissions) following two cycles of treatment with GDP for patients with relapsed or refractory Hodgkin's disease and for patients with relapsed or refractory aggressive histology non-Hodgkin's lymphoma

    NCT Registration ID (from clinicaltrials.gov): NCT00014209
    Participation: Not limited.
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: December 12, 2000 Closing Date: July 12, 2002



    		Permanently Closed
    MY10 (MY10)

    A Randomized Phase III Study Of Thalidomide And Prednisone As Maintenance Therapy Following Autologous Stem Cell Transplant In Patients With Multiple Myeloma


    A Randomized Phase III Study Of Thalidomide And Prednisone As Maintenance Therapy Following Autologous Stem Cell Transplant In Patients With Multiple Myeloma

    Complexity Level: 2

    Eligibility: Patients with histologically confirmed myeloma who had had an autologous stem cell transplant within one year of the beginning of initial treatment for their disease. Patients must be randomized within 60-100 days post transplant and have no other medical condition precluding long term use of prednisone or thalidomide.

    Objectives: Primary: to determine if maintenance treatment post transplant with thalidomide and prednisone (TP) prolongs overall survival compared with observation alone. Secondary: to determine if TP prolongs progression-free survival compared with observation alone; to compare quality of life, toxic effects, and the incidence of venous thromboembolism between the two patient groups. Correlative Studies Endpoints: to correlate FISH-identified chromosome translocations at relapse with clinical outcome in the two patient groups; to determine if there is evidence of increased thrombin generation in patients receiving TP as compared with those not.

    NCT Registration ID (from clinicaltrials.gov): NCT00049673
    Participation: Not limited
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: September 16, 2002 Closing Date: January 30, 2009



    		Permanently Closed
    MDC1 (SWOG S1117)

    A Randomized Phase II/III Study of Azacitidine in Combination with Lenalidomide (NSC-703813) vs. Azacitidine Alone vs. Azacitidine in Combination with Vorinostat (NSC-701852) for Higher-Risk Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML)


    A Randomized Phase II/III Study of Azacitidine in Combination with Lenalidomide (NSC-703813) vs. Azacitidine Alone vs. Azacitidine in Combination with Vorinostat (NSC-701852) for Higher-Risk Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML)

    Complexity Level: 2

    Eligibility: Patients must have morphologically confirmed diagnosis of myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML).

    Objectives: Primary: Response Rate Secondary: Relapse-free Survival; Overall Survival; Cytogenetic Response Rate; Frequency and Severity of Toxicities; Predictors of Response; Optional Tumour Banking

    NCT Registration ID (from clinicaltrials.gov): NCT01522976
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: November 22, 2012 Closing Date: November 15, 2014



    		Permanently Closed
    MY9

    Randomized Phase II Dose Finding Study of Thalidomide and Prednisone as Maintenance Therapy Following Autologous Stem Cell Transplant in Patients With Multiple Myeloma


    Randomized Phase II Dose Finding Study of Thalidomide and Prednisone as Maintenance Therapy Following Autologous Stem Cell Transplant in Patients With Multiple Myeloma

    NCT Registration ID (from clinicaltrials.gov): NCT00006890
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 12, 2000 Closing Date: September 07, 2001



    		Permanently Closed
    MY2

    Continuing versus Stopping Therapy in Patients Stabilized on Melphalan and Prednisone


    Continuing versus Stopping Therapy in Patients Stabilized on Melphalan and Prednisone

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: March 23, 1977 Closing Date: December 14, 1984



    		Permanently Closed
    LY9 (M39045)

    Randomised Intergroup Trial of First Line Treatment for Patients With Diffuse Large B-Cell Non-Hodgkins Lymphoma With a CHOP-Like Chemotherapy Regimen With or Without the Anti-CD20 Antibody Rituximab (IDEC-C2B8)


    Randomised Intergroup Trial of First Line Treatment for Patients With Diffuse Large B-Cell Non-Hodgkins Lymphoma With a CHOP-Like Chemotherapy Regimen With or Without the Anti-CD20 Antibody Rituximab (IDEC-C2B8)

    Complexity Level: 2

    Eligibility: Patients aged 18 to 60 years with untreated CD20-positive diffuse large B-cell non-Hodgkin's lymphoma. Patients must have stage II to IV or stage I with bulky disease according to Ann Arbor staging.

    Objectives: To determine the safety and efficacy of rituximab antibody in patients with diffuse large B-cell non-Hodgkin's lymphoma in combination with a standard CHOP-like chemotherapy regimen. The primary endpoint of this trial is the time to treatment failure.

    NCT Registration ID (from clinicaltrials.gov): NCT00064116
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: May 08, 2001 Closing Date: October 17, 2003



    		Permanently Closed
    CLC1E (CLC1E)

    A Canadian Economic Analysis of CLC.1


    A Canadian Economic Analysis of CLC.1

    Complexity Level: 3

    Eligibility: Tumour Type: CLL Line of Therapy: 1st line therapy Stage of Disease: Previously untreated, early-stage patients who are candidates for observation. Only patients included in the randomized portion of this trial (those with the poor-risk molecular marker) will be included in the Economic Analysis.

    Objectives: Primary: Time to 2nd treatment; The primary outcome of the economic analysis is cost-utility. Utilities will be determined through use of the Euro QoL Eq5D questionnaire. Data to be obtained from Canadian patients includes health care-related resource utilization and lost productivity. Secondary: Overall survival; toxicity; correlative markers; QoL. Secondary outcomes of economic analysis: cost effectiveness related to 'years gained' prior to second therapy and if possible 'years gained'. Lost productivity of the two randomized groups will also be compared.

    NCT Registration ID (from clinicaltrials.gov): no NCT
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 13, 2009 Closing Date: December 24, 2009



    		Permanently Closed
    LY1

    A Trial of BCG in Non-Hogkin's Lymphoma


    A Trial of BCG in Non-Hogkin's Lymphoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 07, 1976 Closing Date: May 01, 1981



    		Permanently Closed
    CL2

    A Phase II Study of Oral Fludarabine Phosphate in Patients with Previously Untreated B-cell Chronic Lymphocytic Leukemia


    A Phase II Study of Oral Fludarabine Phosphate in Patients with Previously Untreated B-cell Chronic Lymphocytic Leukemia

    Eligibility: Patients with previously untreated B-cell chronic lymphocytic leukemia, requiring treatment. Submission of blood samples for immunophenotyping, FISH and PCR studies are a requirement for participation.

    Objectives: To determine overall (CR, PR) response rate. Secondary endpoints include assessment of molecular CR rate, toxicity, progression-free and treatment-free survival as well as determination of the incidence of defined genetic abnormalities in the study population. The prognostic and predictive significance of genetic abnormalities and immunophenotypic profile at the start of treatment, with respect to response to oral fludarabine, will be evaluated.

    NCT Registration ID (from clinicaltrials.gov): NCT00049075
    Participation: Limited to centres expecting to accrue > 4 patients/year
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 08, 2002 Closing Date: January 30, 2004



    		Permanently Closed
    CM1 (SWOG S0325)

    A Phase IIb Study of Molecular Responses to Imatinib at Standard or Increased Doses or Dasatinib (BMS 354825) (NSC-732517) for Previously Untreated Patients with Chronic Myelogenous Leukemia (CML) in Chronic Phase.


    A Phase IIb Study of Molecular Responses to Imatinib at Standard or Increased Doses or Dasatinib (BMS 354825) (NSC-732517) for Previously Untreated Patients with Chronic Myelogenous Leukemia (CML) in Chronic Phase.

    Complexity Level: 2

    Eligibility: Patients with chronic phase CML are eligible based on bone marrow aspirate, biopsy and peripheral blood counts obtained within 14 days before registration. Patients must have confirmed Philadelphia chromosome or variants of the (9-22) translation by cytogenetics or by FISH or be positive for BCR-ABL by RT-PCR. Patients may have secondary chromosomal abnormalities in addition to the Philadelphia chromosomes. Patients must have a Zubroid performance status of 0 - 2. Patients must not have received prior treatment for CML with the exception of hydroxyurea and/or anagrelide. Patients must not have received prior chemotherapy for peripheral blood stem cell mobilization.

    Objectives: 1.1 To test whether increasing the dose of imatinib (STI571, Gleevec®) from 400 mg/day to 800 mg/day increases the rate of molecular response, as measured by the decrease in BCR-ABL transcripts after 12 months of treatment, in patients with previously untreated CML in chronic phase. 1.2 To estimate rates of cytogenetic and hematologic responses to each of the two imatinib dose levels. 1.3 To evaluate in a preliminary manner the prognostic effects of der(9) and der(22) chromosomal deletions for response in CML patients treated with imatinib. 1.4 To investigate in a preliminary manner changes in gene expression at relapse or progression compared to pre-treatment. 1.5 To estimate the frequency and severity of toxicities of the two treatment regimens.

    NCT Registration ID (from clinicaltrials.gov): NCT00070499
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: September 30, 2005 Closing Date: February 28, 2009



    		Permanently Closed
    ALC1 (S0106)

    A Phase III Study Of The Addition Of Mylotarg® During Induction Therapy Verses Standard Induction With Daunomycin & Cytosine Arabinoside Followed By Consolidation & Subsequent Randomization To Post-Consolidation Therapy With Mylotarg® Or No Additional Therapy For Patients Under The Age Of 61 With Previously Untreated De Novo Acute Myeloid Leukemia


    A Phase III Study Of The Addition Of Mylotarg® During Induction Therapy Verses Standard Induction With Daunomycin & Cytosine Arabinoside Followed By Consolidation & Subsequent Randomization To Post-Consolidation Therapy With Mylotarg® Or No Additional Therapy For Patients Under The Age Of 61 With Previously Untreated De Novo Acute Myeloid Leukemia

    Complexity Level: 1

    Eligibility: Patients must have a morphologically confirmed diagnosis of acute myeloid leukemia (AML) with FAB classification other than M3, based on bone marrow aspiration and biopsy performed within 14 days prior to registration.

    Objectives: -Compare DFS of patients under age 56 with previously untreated, de novo, non-M3, AML who receive Mylotarg as post-consolidation therapy versus patients who receive no post-consolidation therapy. -Compare CR rate achieved by the addition of Mylotarg to standard induction chemotherapy in patients under the age of 56 with previously untreated, de novo, non-M3 AML. The durability of complete response will also be measured. -Estimate the frequency and severity of toxicities of the addition of Mylotarg to induction therapy and post-consolidation therapy. -To evaluate the prognostic significance of CD33 expression on the response rate of patients who receive Mylotarg. -To evaluate the prognostic significance of FLT3 mutations and flow through cytometic detection prior to therapy, and of minimal residual disease in remission specimens collected before and after consolidation therapy and after post-consolidation therapy with Mylotarg.

    NCT Registration ID (from clinicaltrials.gov): NCT00085709
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: April 27, 2006 Closing Date: August 20, 2009



    		Permanently Closed
    MY5

    Modified VAD (m-VAD-VINCRISTINE, ADRIAMYCIN, DEXAMETHASONE) in Primary Refractory and Relapsed Plasma Cell Myeloma


    Modified VAD (m-VAD-VINCRISTINE, ADRIAMYCIN, DEXAMETHASONE) in Primary Refractory and Relapsed Plasma Cell Myeloma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 28, 1986 Closing Date: October 17, 1989



    		Permanently Closed
    ALC3 (SWOG S1203)

    A Randomized Phase III Study of Standard Cytarabine plus Daunorubicin (7+3) Therapy or Idarubicin with High Dose Cytarabine (IA) versus IA with Vorinostat (IA+V) in Younger Patients with Previously Untreated Acute Myeloid Leukemia (AML)


    A Randomized Phase III Study of Standard Cytarabine plus Daunorubicin (7+3) Therapy or Idarubicin with High Dose Cytarabine (IA) versus IA with Vorinostat (IA+V) in Younger Patients with Previously Untreated Acute Myeloid Leukemia (AML)

    Complexity Level: 1

    Eligibility: Patients must have morphologically confirmed newly diagnosed acute myelogenous leukemia (AML).

    Objectives: Primary:event-free survival; feasibility of completing an allogeneic hematopoietic cell transplantation in 60% or more of patients in frist complete remission.

    NCT Registration ID (from clinicaltrials.gov): NCT01802333
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: September 10, 2013 Closing Date: November 04, 2015



    		Permanently Closed
    CL3 (CALGB C10404)

    A Genetic, Risk-Stratified Randomized Phase II Study of Four Fludarabine/Antibody Combinations For Patients with Symptomatic Previously Untreated Chronic Lymphocytic Leukemia


    A Genetic, Risk-Stratified Randomized Phase II Study of Four Fludarabine/Antibody Combinations For Patients with Symptomatic Previously Untreated Chronic Lymphocytic Leukemia

    Complexity Level: 2

    Eligibility: B-cell chronic lymphocytic leukemia (CLL); Creatinine less than or equal to 1.5 x ULN; Lymphocytosis > 5,000/uL with less than 55% prolymphocytes; Bone marrow aspirate with > 30% of all nucleated cells being lymphoid or bone marrow core biopsy must show lymphoid infiltrates compatible with marrow involvement by CLL; Overall cellularity must be normocellular or hypercellular; Monoclonal B-cell population that is positive for >/= 1 B-lineage markers (CD19, CD20, CD23) with co-expression of CD5 (bright surface immunoglobulin patients must co-express CD23): Symptomatic and active intermediate risk (lymphadenopathy and/or hepatosplenomegaly) or high risk (Hgb less than 11 g/dL or platelets less than 100,000/uL) category of modified Rai staging system; No prior therapy for CLL; No medical condition requiring chronic use of oral corticosteroids; Age >/= 18 years; Performance Status 0 - 2; HIV patients may be eligible if the criteria are met; Non-pregnant and non-nursing

    Objectives: Progression free survival

    NCT Registration ID (from clinicaltrials.gov): NCT00602459
    Participation: Limited to invited centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: January 13, 2009 Closing Date: August 17, 2012



    		Permanently Closed
    LY7 (EORTC 20981)

    Chimeric Anti-CD20 Monoclonal Antibody (Rituximab)in Remission Induction and Maintenance Treatment of Relapsed Follicular Non-Hodgkins Lymphoma: A Phase III Randomized Clinical Trial


    Chimeric Anti-CD20 Monoclonal Antibody (Rituximab)in Remission Induction and Maintenance Treatment of Relapsed Follicular Non-Hodgkins Lymphoma: A Phase III Randomized Clinical Trial

    Complexity Level: 2

    Eligibility: Patients with stage III or IV follicular non-Hodgkin's lymphoma (at initial diagnosis) who have relapsed after a maximum of two non-anthracycline containing systemic chemotherapy regimens. Patients must have had a complete or partial response to at least one of the previous regimens. Lymphoma must be CD20 positive.

    Objectives: To establish the effect of addition of rituximab to CHOP chemotherapy on the response rate and quality of remission in relapsed low grade non-Hodgkin's lymphoma. To establish the effect of maintenance treatment with rituximab on progression free survival in relapsed low grade non-Hodgkin's lymphoma in remission after CHOP ± rituximab.

    NCT Registration ID (from clinicaltrials.gov): NCT00004179
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: May 15, 2000 Closing Date: February 06, 2004



    		Permanently Closed
    AL3 (CALGB C9710)

    Phase III Randomized Study of Concurrent Tretinoin and Chemotherapy With or Without Arsenic Trioxide (AS2O3) (NSC # 706363) as Initial Consolidation Therapy Followed by Maintenance Therapy with Intermittent Tretinoin vs Intermittent Tretinoin Plus Mercaptopurine and Methotrexate for Patients with Untreated Acute Promyelocytic Leukemia


    Phase III Randomized Study of Concurrent Tretinoin and Chemotherapy With or Without Arsenic Trioxide (AS2O3) (NSC # 706363) as Initial Consolidation Therapy Followed by Maintenance Therapy with Intermittent Tretinoin vs Intermittent Tretinoin Plus Mercaptopurine and Methotrexate for Patients with Untreated Acute Promyelocytic Leukemia

    Complexity Level: 1

    Eligibility: Diagnosis of acute promyelocytic leukemia (APL) with proof of APL morphology (FAB-M3) confirmed by RT-PCR assay. Prior treatment: No systemic definitive treatment for APL, including cytotoxic chemotherapy or retinoids. Prior therapy with corticosteroids, hydroxyurea or leukapheresis will not exclude the patient. Non-pregnant, non-nursing. Treatment under this protocol would expose an unborn child to significant risks. Patients should not become pregnant or plan to become pregnant while on treatment.

    Objectives: To compare the efficacy (event-free survival) and toxicities of two induction/consolidation therapies for patients with untreated APL: ATRA/ara-C/daunorubicin with or without arsenic trioxide (AS2O3). To evaluate the efficacy (disease-free survival) and toxicities of maintenance therapy with intermittent ATRA versus intermittent ATRA plus 6-MP/MTX for patients with APL who achieve a complete response.

    NCT Registration ID (from clinicaltrials.gov): NCT00003934
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: April 18, 2002 Closing Date: March 29, 2005



    		Permanently Closed
    MY11

    A Randomized Phase II Dose Finding Study of Lenalidomide and Melphalan in Patients With Previously Untreated Multiple Myeloma


    A Randomized Phase II Dose Finding Study of Lenalidomide and Melphalan in Patients With Previously Untreated Multiple Myeloma

    Eligibility: Previously untreated patients with histologically confirmed myeloma who are not considered candidates for future peripheral blood stem cell autotransplantation by virtue of advanced age, co-morbid illness or patient preference.

    Objectives: Primary: 1) To evaluate the tolerability of combination therapy with lenalidomide and melphalan in patients with previously untreated multiple myeloma not destined for future autologous stem cell transplant. Two starting doses of lenalidomide (15mg or 10mg days 1-21 each 28 day cycle) will be investigated. 2) To determine an estimate of the efficacy of the combination of melphalan and lenalidomide. The primary measure of efficacy will be the percentage of patients who, after completing six cycles of therapy, achieve a complete remission using European Group for Blood and Marrow Transplantation/International Bone marrow transplant registry criteria for remission assessment.

    NCT Registration ID (from clinicaltrials.gov): NCT00305812
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: December 13, 2005 Closing Date: March 27, 2008



    		Permanently Closed
    LY15

    A Phase I Study of Romidepsin, Gemcitabine, Dexamethasone and Cisplatin Combination Therapy in the Treatment of Peripheral T-Cell and Diffuse Large B-Cell Lymphoma.


    A Phase I Study of Romidepsin, Gemcitabine, Dexamethasone and Cisplatin Combination Therapy in the Treatment of Peripheral T-Cell and Diffuse Large B-Cell Lymphoma.

    Complexity Level: 2

    Eligibility: Patients enrolled in this study must have histologically confirmed peripheral T cell lymphoma (PTCL) or diffuse large B cell lymphoma, and must have received one or two previous treatment regimens (histologic proof of disease by biopsy is mandatory). There must be clinically or radiologically measurable disease at baseline.

    Objectives: - To evaluate the safety and feasibility of the combination of gemcitabine, dexamethasone and cisplatin (GDP) and romidepsin in relapsed/refractory aggressive lymphomas (including PTCL and DLBCL). - To identify the maximum tolerated doses of romidepsin, gemcitabine, dexamethasone and cisplatin used in combination. - To evaluate preliminary evidence of anti-tumour activity. - To establish a recommended phase II dose of romidepsin to be given in combination with GDP in a planned randomized phase II trial in newly diagnosed untreated PTCL.

    NCT Registration ID (from clinicaltrials.gov): NCT01846390
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 30, 2013 Closing Date: April 26, 2016



    		Permanently Closed
    ALC2 (CALGB C10603)

    A Phase III Randomized, Double-Blind Study of Induction (Daunorubicin/Cytarabine) and Consolidation (High-Dose Cytarabine) Chemotherapy + Midostaurin (PK412) (IND # 101261) or Placebo in Newly Diagnosed Patients < 60 Years of Age With FLT3 Mutated Acute Myeloid Leukemia (AML).


    A Phase III Randomized, Double-Blind Study of Induction (Daunorubicin/Cytarabine) and Consolidation (High-Dose Cytarabine) Chemotherapy + Midostaurin (PK412) (IND # 101261) or Placebo in Newly Diagnosed Patients < 60 Years of Age With FLT3 Mutated Acute Myeloid Leukemia (AML).

    Complexity Level: 1

    Eligibility: Unequivocal diagnosis of AML (>20% blasts in the bone marrow based on the WHO classification, excluding M3 (acute promyelocytic leukemia); Documented FLT3 mutation (ITD or point mutation), determined by analysis in a protocol-designated FLT3 screening laboratory; Age 18 and < 60 years; No prior chemotherapy for leukemia or myelodysplasia with the following exceptions: emergency leukapheresis; emergency treatment for hyperleukocytosis with hydroxyurea for 5 days; cranial RT for CNS leukostasis (one dose only); growth factor/cytokine support. AML patients with a history of antecedent myelodysplasia (MDS) remain eligible for treatment on this trial, but must not have had prior cytotoxic (including azacitidine or decitabine) therapy for MDS; Patients who have developed therapy related AML after prior RT or chemotherapy for another disorder or cancer are not eligible; Patients with symptomatic congestive heart failure are not eligible; Bili < 2.5 UNL; Non-pregnant and non-nursing.

    Objectives: Overall Survival Complete response rate in remission induction, event-free survival, disease-free survival and the DRS rate one year after completing maintenance

    NCT Registration ID (from clinicaltrials.gov): NCT00651261
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: April 21, 2009 Closing Date: October 14, 2011



    		Permanently Closed
    LY11 (S9704)

    A Randomized Phase III Trial Comparing Early High Dose Chemoradiotherapy and an Autologous Stem Cell Transplant to Conventional Dose CHOP Chemotherapy Plus Rituximab for CD20+B-Cell Lymphomas (With Possible Late Autologous Stem Cell Transplant)for Patients With Diffuse Aggressive Non-Hodgkin's Lymphoma in the High-Intermediate/High Risk International Classification Prognostic Groups


    A Randomized Phase III Trial Comparing Early High Dose Chemoradiotherapy and an Autologous Stem Cell Transplant to Conventional Dose CHOP Chemotherapy Plus Rituximab for CD20+B-Cell Lymphomas (With Possible Late Autologous Stem Cell Transplant)for Patients With Diffuse Aggressive Non-Hodgkin's Lymphoma in the High-Intermediate/High Risk International Classification Prognostic Groups

    Complexity Level: 1

    Eligibility: Patients must have biopsy proven intermediate or high grade non-Hodgkin's lymphoma (Working Formulation groups D through H and J) except lymphoblastic lymphoma (Working Formulation group I). Transformed lymphomas are not eligible. Mantle cell lymphomas are considered to be Working Formulation group E, but are ineligible for this study.

    Objectives: To compare in a cooperative group setting the overall survival and progression free survival of patients in the age adjusted High-Intermediate and High Risk Prognostic Groups of the International Classification with diffuse aggressive non-Hodgkin¿s lymphomas who are treated on a randomized trial that compares standard conventional chemotherapy to an abbreviated course of induction chemotherapy followed by early transplantation. To compare the toxicity of these treatment strategies.

    NCT Registration ID (from clinicaltrials.gov): NCT00004031
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: November 28, 2001 Closing Date: December 15, 2007



    		Permanently Closed
    MY8 (E1A95)

    A Phase III Study Of PSC-833 In Combination With Vincristine, Doxorubicin And Dexamethasone (PSC-833/VAD) vs VAD Alone In Patients With Relapsing Or Refractory Mutilple Myeloma


    A Phase III Study Of PSC-833 In Combination With Vincristine, Doxorubicin And Dexamethasone (PSC-833/VAD) vs VAD Alone In Patients With Relapsing Or Refractory Mutilple Myeloma

    NCT Registration ID (from clinicaltrials.gov): NCT00002878
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: July 28, 1997 Closing Date: May 10, 2000



    		Permanently Closed
    HD7 (ECOG E2496)

    A Randomized Phase III Trial of ABVD Versus Stanford V with or without Radiation Therapy in Locally Extensive and Advanced Stage Hodgkin's Disease


    A Randomized Phase III Trial of ABVD Versus Stanford V with or without Radiation Therapy in Locally Extensive and Advanced Stage Hodgkin's Disease

    Complexity Level: 2

    Eligibility: Previously untreated patients with histologically proven Hodgkin's disease (HD). The diagnosis should be made by excisional biopsy whenever possible, but fine needle aspirate may suffice if 1) the morphology is unequivocal and 2) immunohistochemical studies are consistent with the diagnosis of HD. ECOG performance status must be 0 - 2.

    Objectives: To compare the failure-free survival in patients with locally extensive and advanced stage Hodgkin's disease treated with standard ABVD chemotherapy versus patients given Stanford V chemotherapy with or without radiotherapy. To assess overall survival and freedom from progression in these patients at 5 and 10 years. To assess secondary endpoints: pulmonary function, incidence of second cancers, reproductive function (baseline and 5 years) and deaths from causes other than Hodgkin's disease.

    NCT Registration ID (from clinicaltrials.gov): NCT00003389
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: June 07, 2000 Closing Date: June 15, 2006



    		Permanently Closed
    HL1 (8691)

    A Randomized Comparison of Deoxycoformycin versus Alpha Interferon in Previously Untreated Patients With Hairy Cell Leukemia


    A Randomized Comparison of Deoxycoformycin versus Alpha Interferon in Previously Untreated Patients With Hairy Cell Leukemia

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: January 05, 1987 Closing Date: October 01, 1991



    		Permanently Closed
    AL2 (INT 0129)

    Phase III Randomized Study of All-Trans Retinoic Acid versus Cytosine Arabinoside and Daunorubicin as Inductive Therapy for Patients with Previously Untreated Acute Promyelocytic Leukemia


    Phase III Randomized Study of All-Trans Retinoic Acid versus Cytosine Arabinoside and Daunorubicin as Inductive Therapy for Patients with Previously Untreated Acute Promyelocytic Leukemia

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: August 01, 1992 Closing Date: February 01, 1995



    		Permanently Closed
    HD5 (8952)

    Treatment of Advanced Hodgkin's Disease a Randomized Phase III Trial Comparing ABVD versus MOPP/ABV Hybrid


    Treatment of Advanced Hodgkin's Disease a Randomized Phase III Trial Comparing ABVD versus MOPP/ABV Hybrid

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: February 01, 1993 Closing Date: November 10, 1995



    		Permanently Closed
    MY1

    A Comparison of the Administration of Melphalan, Cyclophosphamide and BCNU in Sequential Alternating and Concurrent Schedules in the Treatment of Plasma Cell Myeloma


    A Comparison of the Administration of Melphalan, Cyclophosphamide and BCNU in Sequential Alternating and Concurrent Schedules in the Treatment of Plasma Cell Myeloma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 01, 1973 Closing Date: March 01, 1977



    		Permanently Closed
    LY4

    Phase I/II Study of Chemotherapy Intensification for Patients With Poor Prognosis Advanced Stage Aggressive histology Lymphoma: VACOP-B Plus Etoposide and Cyclophosphamide With RhuGM-CSF (VACOP-B/EC/CSF)


    Phase I/II Study of Chemotherapy Intensification for Patients With Poor Prognosis Advanced Stage Aggressive histology Lymphoma: VACOP-B Plus Etoposide and Cyclophosphamide With RhuGM-CSF (VACOP-B/EC/CSF)

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: May 01, 1992 Closing Date: October 25, 1994



    		Permanently Closed
    LY8

    A Phase III Study of Involved Field Radiation Therapy (IFRT) in Patients With Histologically Aggressive Non-Hodgkin's Lymphoma Following High Dose Chemotherapy and Autologous Hematopoietic Stem Cell Transplantation (ASCT)


    A Phase III Study of Involved Field Radiation Therapy (IFRT) in Patients With Histologically Aggressive Non-Hodgkin's Lymphoma Following High Dose Chemotherapy and Autologous Hematopoietic Stem Cell Transplantation (ASCT)

    Eligibility: Patients with relapsed or refractory histologically aggressive non-Hodgkin¿s lymphomas, who showed chemotherapy sensitivity will undergo high-dose therapy and autologous bone marrow/blood stem cell transplantation. Patients with bulky disease (> 5 cm) before initiation of salvage chemotherapy, and those with non-bulky disease not achieving a complete response to salvage chemotherapy are eligible.

    Objectives: To compare overall survival, 3-year progression free survival (within and outside of radiation fields), QOL and toxicities between patients treated with IFRT and those observed.

    NCT Registration ID (from clinicaltrials.gov): NCT0031668
    Participation: Not limited
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 31, 2001 Closing Date: November 11, 2002



    		Permanently Closed
    AL4 (DFCI 01-175)

    A Multi-Center Phase II Study in Adults with Untreated Acute Lymphoblastic Leukemia: Testing Pharmacokinetically Individualized Doses of L-Asparaginase Following the DFCI Pediatric Consortium Protocol


    A Multi-Center Phase II Study in Adults with Untreated Acute Lymphoblastic Leukemia: Testing Pharmacokinetically Individualized Doses of L-Asparaginase Following the DFCI Pediatric Consortium Protocol

    Complexity Level: 1

    Eligibility: Patients must have pathologically documented de novo acute lymphoblastc leukemia, excluding mature B-cell ALL, which is diagnosed by the presence of either surface immunoglogulin, L3 morphology or one of the following cytogentic abnormalities t(8;14)(q24;q32), t(8;22), or t(2;8).

    Objectives: To determine the feasibility, toxicity and efficacy of the high-risk pediatric treatment regimen in adult patients 18 years of age and older. To determine the safety and optimal dosing of L-asparaginase during the intensification period. To determine the pharmacokinetics of weekly E.coli L-asparaginase by evaluating serum asparaginase levels in all patients To determine the toxicity of individualized dosing of E.coli L-asparaginase based upon asparaginase levels To determine the prognostic significance of early response to induction chemotherapy within the context of our treatment program To evaluate the outcome of patients based upon bone marrow status after 15 days of multi-agent induction chemotherapy, comparing the outcome of patients with M3 status (>25% leukemia cells still present) at that time point versus those with M1/M2 status (<25% leukemia cells still present) or hypoplastic marrows. To evaluate the outcome of patients base

    NCT Registration ID (from clinicaltrials.gov): NCT00136435
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: January 24, 2005 Closing Date: February 21, 2008



    		Permanently Closed
    CLC1 (CALGB C10501)

    A Phase III Intergroup CLL Study of Asymptomatic, Untreated Chronic Lymphocytic Leukemia Patients Randomized to Early Intervention versus Observation in the High Risk Genetic Subset with IG VH Un-mutated Disease


    A Phase III Intergroup CLL Study of Asymptomatic, Untreated Chronic Lymphocytic Leukemia Patients Randomized to Early Intervention versus Observation in the High Risk Genetic Subset with IG VH Un-mutated Disease

    Complexity Level: 2

    Eligibility: Patients must be within 6 months of the initial flow cytometric confirmation of b-cell chronic lymphocytic leukemia (CLL). This interval begins with the initial flow cytometric conformation of disease. Clinical and immunophenotypic documentation of CLL including: - Lymphocytosis >5000 uL with <55% prolymphocytes - Monoclonal B-cell population is positive for > 1 B-lineage marker (CD19, CD20, CD23) with co-expression of CD5. Patients with bright surface immunoglobulin levels must have CD23 co-expression and absence of t(11:14)on interphase sytogenetics or have negative tumor protein staining for cyclin D1. Asymptomatic low risk category of modified Rai staging system (Rai stage 0-1). No prior therapy for CLL including corticosteroids; Age > 18yrs; Performance status 0-1; No HIV disease; Non-pregnant and non-nursing.

    Objectives: To determine if early treatment with chemoimmunotherapy extends the time to second treatment (TT2T), and overall survival in genetically high-risk (un-mutated Ig VH), newly diagnosed, asymptomatic CLL patients.

    NCT Registration ID (from clinicaltrials.gov): NCT00513747
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: July 18, 2008 Closing Date: December 24, 2009



    		Permanently Closed
    MY7

    A Comparative Study of Dexamethasone versus Prednisone (Both in Combination With Melphalan) as Induction Therapy in Untreated Symptomatic Myeloma With an Additional Assessment of Dexamethasone versus no Additional Treatment as Maintenance Therapy in Non-Progressing Patients


    A Comparative Study of Dexamethasone versus Prednisone (Both in Combination With Melphalan) as Induction Therapy in Untreated Symptomatic Myeloma With an Additional Assessment of Dexamethasone versus no Additional Treatment as Maintenance Therapy in Non-Progressing Patients

    Eligibility: Patient with newly diagnosed, histologically proven, untreated, symptomatic Stage I or Stage II or III myeloma, with either a measurable serum M-protein or Bence Jones M-protein of >1.0g/24h and an ECOG performance status of <4.

    Objectives: To Compare overall survival between patients receiving M+P versus M+D as induction therapy and patients maintained by dexamethasone versus observation. To compare time progression, response rates, incidences of toxicities and quality of life with the same groups of patients.

    NCT Registration ID (from clinicaltrials.gov): NCT00002678
    Participation: Not limited
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 02, 1995 Closing Date: July 16, 2003



    		Permanently Closed
    MY3

    Pilot Study of Weekly Cyclophosphamide and Prednisone Therapy for Patients Unresponsive to Melphalan and Prednisone Induction Therapy


    Pilot Study of Weekly Cyclophosphamide and Prednisone Therapy for Patients Unresponsive to Melphalan and Prednisone Induction Therapy

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: February 01, 1982 Closing Date: September 01, 1984



    		Permanently Closed
    MYX1 (MCRN-003)

    A Single Arm Phase II Study of High-Dose Weekly Carfilzomib plus Cyclophosphamide and Dexamethasone in the Treatment of Relapsed Multiple Myeloma After 1-3 Prior Therapies


    A Single Arm Phase II Study of High-Dose Weekly Carfilzomib plus Cyclophosphamide and Dexamethasone in the Treatment of Relapsed Multiple Myeloma After 1-3 Prior Therapies

    Complexity Level: 2

    Eligibility: Enrolled patients must meet standard diagnostic criteria for multiple myeloma. They must have relapsed disease according to the International Myeloma Working group criteria. Prior autologous stem cell transplant is allowed but not required. This study will be restricted to patients who have had at least one, but not more than three, prior lines of therapy.

    Objectives: The primary objective of the Phase II portion of the study is to determine the overall response rate of this novel drug combination. The secondary objectives are: 1. To determine the safety and toxicity profile of the combination 2. To determine the progression-free survival 3. To determine the 2-year overall survival

    NCT Registration ID (from clinicaltrials.gov): NCT02597062
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Permanently Closed
    Activation Date: March 29, 2016 Closing Date: January 25, 2018



    		Permanently Closed
    HD6

    A Phase III Study of Radiotherapy or ABVD Plus Radiotherapy versus ABVD Alone in the Treatment of Early Stage Hodgkin's Disease


    A Phase III Study of Radiotherapy or ABVD Plus Radiotherapy versus ABVD Alone in the Treatment of Early Stage Hodgkin's Disease

    Eligibility: Patients with clinical stage I or IIA previously untreated Hodgkin's disease, excluding patients with very favourable or very unfavourable (bulky mediastinum) prognosis.

    Objectives: To compare 12 year survival between groups, to assess freedom from progression at 5 and 10 years, and to assess secondary endpoints: proportion of complete remission, proportion free from 2nd disease progression at 5 and 10 years, cause specific survival, toxicity, and quality of life.

    NCT Registration ID (from clinicaltrials.gov): NCT00002561
    Participation: Limited to centres with current CPA #
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 25, 1994 Closing Date: April 05, 2002



    		Permanently Closed
    HD3

    Protocol For a Second Cooperative Clinical Trial for the Treatment of Patients With Stages IVB and IV Hodgkin's Disease Using Chemotherapy and Irradiation Therapy


    Protocol For a Second Cooperative Clinical Trial for the Treatment of Patients With Stages IVB and IV Hodgkin's Disease Using Chemotherapy and Irradiation Therapy

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 01, 1977 Closing Date: May 01, 1980



    		Permanently Closed
    LY13

    A Multi-centre Phase II Trial Investigating the Efficacy and Tolerability of Bortezomib Added to Cyclophosphamide, Vincristine, Prednisone and Rituximab (BCVP-R) for Patients with Advanced Stage Follicular Non-Hodgkin's Lymphoma Requiring Systemic First-Line Treatment


    A Multi-centre Phase II Trial Investigating the Efficacy and Tolerability of Bortezomib Added to Cyclophosphamide, Vincristine, Prednisone and Rituximab (BCVP-R) for Patients with Advanced Stage Follicular Non-Hodgkin's Lymphoma Requiring Systemic First-Line Treatment

    Eligibility: Patients with histologically confirmed, advanced stage (III or IV) follicular lymphoma requiring systemic first-line treatment will be eligible.

    Objectives: Primary: To assess the efficacy (complete response rate, CR/CRu) of BCVP-R as treatment for patients with advanced stage follicular non-Hodgkin's lymphoma requiring systemic first-line treatment; to assess the incidence of severe neurotoxicity (defined as grade 3 or 4 neuropathy/ neuropathic pain during the first four cycles) of the BCVP-R regimen in this group of patients. Secondary: To assess overall response rate in patients treated with the combination of BCVP-R, and to determine the response duration; to determine progression-free and overall survival in this patient group; to evaluate the tolerability and characterize the toxicity profile of the BCVP-R regimen in this patient population; to assess quality of life with particular focus on neurotoxicity-related changes in this patient population treated with BCVP-R. Correlative Studies. Apoptocic molecule expression, the role of the microenvironment, and Fc receptor polymorphisms.

    NCT Registration ID (from clinicaltrials.gov): NCT00428142
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: December 14, 2006 Closing Date: March 06, 2009



    		Permanently Closed
    MY6

    Clinical Trial of Interferon versus no Additional Treatment in Multiple Myeloma Patients Who Have Responded to Melphalan and Prednisone


    Clinical Trial of Interferon versus no Additional Treatment in Multiple Myeloma Patients Who Have Responded to Melphalan and Prednisone

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: February 04, 1987 Closing Date: June 26, 1992



    		Permanently Closed
    HD1

    Protocol For a Cooperative Clinical Trial Comparing MOPP Alone versus MOPP Followed by Radiation in Stage IIIB and IV Hodgkin's Disease


    Protocol For a Cooperative Clinical Trial Comparing MOPP Alone versus MOPP Followed by Radiation in Stage IIIB and IV Hodgkin's Disease

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: December 01, 1971 Closing Date: September 01, 1976



    		Permanently Closed
    CL1 (9011)

    A Phase III Comparison of Fludarabine Phosphate (NSC #312887) vs Chlorambucil vs Fludarabine Phosphate + Chlorambucil in Previously Untreated B-Cell Chronic Lymphocytic Leukemia


    A Phase III Comparison of Fludarabine Phosphate (NSC #312887) vs Chlorambucil vs Fludarabine Phosphate + Chlorambucil in Previously Untreated B-Cell Chronic Lymphocytic Leukemia

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: March 08, 1991 Closing Date: December 07, 1994



    		Permanently Closed
    HD8 (EORTC 20012)

    BEACOPP (4 cycles escalated + 4 cycles baseline) versus ABVD (8 cycles) in stage III & IV Hodgkin's lymphoma


    BEACOPP (4 cycles escalated + 4 cycles baseline) versus ABVD (8 cycles) in stage III & IV Hodgkin's lymphoma

    Complexity Level: 2

    Eligibility: Patients with histologically documented Hodgkin's lymphoma/disease, except for the subtype lymphocyte predominant, nodular type (nodular paragranuloma). Patients must be clinical stage III or IV and have at least one bi-dimensionally measurable target lesion. Patients with extranodal disease only will be eligible if they have at least one bi-dimensionally measurable extranodal lesion.

    Objectives: The primary end point is Event-Free-Survival (EFS), also called Time to Treatment Failure or Freedom From Treatment Failure (FFTF). For this end-point, an "event" is defined as early discontinuation of protocol treatment, absence of CR after 8 cycles, relapse, progression or death. The secondary endpoints are: complete response (CR), disease free survival (DFS) in CR patients, overall survival (OS), quality of life (QoL), occurrence of second malignancies and cost effectiveness.

    NCT Registration ID (from clinicaltrials.gov): NCT00049595
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: May 13, 2003 Closing Date: January 08, 2010



    		Permanently Closed
    LY3

    A Comparison of Standard BACOP With Escalated BACOP in Patients With Poor Prognosis Non-Hodgkin's Lymphoma


    A Comparison of Standard BACOP With Escalated BACOP in Patients With Poor Prognosis Non-Hodgkin's Lymphoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: March 10, 1982 Closing Date: April 19, 1989



    		Permanently Closed
    AL1

    Reinduction and Maintenance of Second or Third Remissions in Children With Acute Lymphoblastic and Acute Undifferentiated Leukemia


    Reinduction and Maintenance of Second or Third Remissions in Children With Acute Lymphoblastic and Acute Undifferentiated Leukemia

    Eligibility: Histologic or cytologic proof of pancreatic adenocarcinoma or adenosquamous carcinoma TNM Stage: Tx-4, N0-1, M0 Local radiographic reading consistent with resectable disease Measurable disease and/or non-measurable disease Confirmation of resectable disease by real-time central imaging review by the Alliance Imaging Core Lab at IROC Ohio Determined to be appropriate candidate for curative-intent pancreatectomy No prior radiation therapy, chemotherapy, targeted therapy, investigational therapy or surgery for pancreatic cancer Not pregnant and not nursing Age >/= 18 years ECOG Performance Status 0-1 Total Neuropathy Score < 2 No known Gilbert's Syndrome or known homozygosity for UGATA1A1*28 polymorphism No comorbid conditions that would prohibit curative-intent pancreatectomy Chronic concomitant treatment with strong inhibitors and/or inducers of CYP3A4 is not allowed.

    Objectives: Primary Objective is Overall Survival. Secondary Objectives: To evaluate and compare the following in patients with resectable pancreatic adenocarcinoma treated with perioperative mFOLFIRINOX and surgery versus up-front surgery followed by adjuvant mFOLFIRINOX: " disease-free survival (DFS) " time to locoregional recurrence (TLR) " time to distant metastases (TDM " R0 resection rate " rate of unresectability, " mFOLFIRINOX dose intensity delivered and number of cycles received " adverse event profile To evaluate rate of pathologic complete response in patients randomized to the perioperative therapy arm To compare physical functioning, nausea/vomiting, and diarrhea, as measured with the EORTC QLQ-C30 between arms. To prospectively assess the influence of diet,BMI, weight loss, physical activity, and other lifestyle habits on DFS and OD among patients with localized pancreatic cancer.

    NCT Registration ID (from clinicaltrials.gov): no NCT
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: May 07, 1981 Closing Date: June 08, 1982



    		Permanently Closed

    Ind

    IDStudy TitleStatus
    I222

    A Phase I Study of the mTORC1/mTORC2 Kinase Inhibitor AZD2014 in Patients with Previously Treated Glioblastoma Multiforme


    A Phase I Study of the mTORC1/mTORC2 Kinase Inhibitor AZD2014 in Patients with Previously Treated Glioblastoma Multiforme

    Complexity Level: 1

    Eligibility: Histologically confirmed glioblastoma multiforme that is recurrent after primary treatment, phase II must have measurable disease according to RANO criteria. ECOG 0-1. Radiation completed >= 4 weeks prior registration; surgery within 21 days (excluding resection). No clinically significant cardiac disease in last 12 months such as (coronary artery bypass graft, angioplasty, vascular stent, MI, congestive heart failure NYHA Grade 2, ventricular arrhythmias requiring continuous therapy, uncontrolled arrhythmias including atrial fibrillation, hemorrhagic or thrombotic stroke). No hepatitis B, hepatitis C, HIV or a prior history of tuberculosis, or diabetes type I or uncontrolled type II. No interstitial lung disease. No GI disease, meningeal or extracranial GBM involvement. No known QT/QTc-prolonging drugs. Stable or decreasing dose of corticosteroids. No enzyme inducing anticonvulsants. No medications that are metabolized by CYP3A4/5 5 and CYP2C8, Pgp (MDR1) and BCRP

    Objectives: Primary:To determine the recommended phase II dose (RP2D) of AZD2014 in patients receiving standard temozolomide treatment. To estimate the 6 month PFS rate in patients receiving AZD2014 in addition to their standard temozolomide treatment Secondary:To evaluate the plasma levels of AZD2014 alone at the time of resection. To assess the safety and toxicity profile of AZD2014 in patients receiving standard temozolomide treatment. To evaluate potential biomarkers such as PTEN, PI3KCA and other mutations, as well as evidence of pharmacodynamic effects in resected and archival tumour tissue.

    NCT Registration ID (from clinicaltrials.gov): NCT02619864
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Permanently Closed
    Activation Date: January 13, 2016 Closing Date: October 19, 2018



    		Permanently Closed
    I204

    A Phase II Study of PX-866 in Patients with Glioblastoma Multiforme at Time of First Relapse or Progression.


    A Phase II Study of PX-866 in Patients with Glioblastoma Multiforme at Time of First Relapse or Progression.

    Complexity Level: 2

    Eligibility: Patients must have histologically confirmed diagnosis of glioblastoma multiforme (GBM), with recurrent or progressive disease following or during primary treatment not curable with standard therapies. Must have formalin fixed paraffin embedded tissue available for translational studies. Presence of bidimensionally measurable enhancing lesions on CT or MRI, with at least one lesion with a minimum dimension of 1 cm x 1 cm (i.e. both dimensions must be > 1.0 cm). ECOG performance of 0, 1 or 2.Age > 18 years of age. Patients may have received prior adjuvant chemotherapy and/or concurrent chemoradiation as part of primary therapy, but must have received no therapy for recurrent/ progressive GBM

    Objectives: To determine the efficacy of PX-866 given orally daily in patients with glioblastoma at the time of first relapse or progression as assessed by objective response and early progression rates. To determine the safety and tolerability of PX-866 in patients with glioblastoma at first relapse/progression given in a daily oral schedule. To explore the relationship between objective response and molecular markers in archival tissue from glioblastoma patients treated with PX-866 orally daily.

    NCT Registration ID (from clinicaltrials.gov): NCT01259869
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: December 09, 2010 Closing Date: September 24, 2012



    		Permanently Closed
    I48

    NCIC CTG Phase II Study of "Intensive PCV-3" Chemotherapy For Anaplastic Oligodendroglioma


    NCIC CTG Phase II Study of "Intensive PCV-3" Chemotherapy For Anaplastic Oligodendroglioma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: February 06, 1989 Closing Date: September 02, 1992



    		Permanently Closed
    I139

    A Phase II Study of T138067-Sodium in Patients With Malignant Glioma


    A Phase II Study of T138067-Sodium in Patients With Malignant Glioma

    Eligibility: Histologically proven malignant glioma (glioblastoma multiforme or anaplastic astrocytoma). Recurrent or progressive disease following primary surgery and radiation treatment. Up to ONE prior chemotherapy regimen in the adjuvant setting, no chemotherapy for recurrence. Stable dose of steroid for > 14 days prior to registration.

    Objectives: To determine the efficacy and toxicity of T138067-sodium in patients with recurrent malignant glioma when given as a weekly 3-hour infusion. To determine the pharmacokinetics of T138067-sodium in a subset of patients (6) enrolled on this study.

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: November 08, 2000 Closing Date: January 09, 2002



    		Permanently Closed
    I27

    NCIC CTG Phase II Study of Trimetrexate in Glioma


    NCIC CTG Phase II Study of Trimetrexate in Glioma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 28, 1986 Closing Date: March 14, 1988



    		Permanently Closed
    I170

    A Phase I/II Study of GW572016 in Patients With Recurrent Malignant Glioma


    A Phase I/II Study of GW572016 in Patients With Recurrent Malignant Glioma

    Eligibility: Patients with recurrent glioblastoma multiforme (GBM) following primary surgery and radiation. No prior chemotherapy for recurrent disease permitted. Bidimensionally measureable disease. Stable dose of steriods. Paraffin embedded tumour sample available for study.

    Objectives: To determine the toxicity, MAD, and RPII dose of GW572016 when given in patients with GBM taking CYP3A4 enzyme inducing anti-epileptic drugs. To assess the efficacy of GW572016 when administered daily in appropriate recommended doses to patients with recurrent GBM.

    NCT Registration ID (from clinicaltrials.gov): NCT00099060
    Participation: Participation in this study is restricted to invited centres.
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: December 16, 2004 Closing Date: May 08, 2007



    		Permanently Closed
    I142

    A Phase II Study of SarNU (NSC 364432) in Patients With Malignant Glioma


    A Phase II Study of SarNU (NSC 364432) in Patients With Malignant Glioma

    Eligibility: Patients with recurrent histologically proven malignant glioma (anaplastic astrocytoma or glioblastoma multiforme). Patients with anaplastic astrocytoma may have had up to ONE prior chemotherapy regimen in the adjuvant setting, but NO chemotherapy for recurrence. Patients with glioblastoma multiforme must be chemotherapy-naïve. Bidimensionally measurable enhancing lesions on CT or MRI.

    Objectives: To determine the efficacy of SarCNU given orally on days 1, 5 and 9 every 6 weeks in patients with recurrent malignant glioma. To determine time to progression, survival and qualitative and quantitative toxicity of SarCNU in this schedule in this patient population. Laboratory correlative studies will also be done.

    NCT Registration ID (from clinicaltrials.gov): NCT00036660
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 10, 2002 Closing Date: December 17, 2002



    		Permanently Closed
    I54

    NCIC CTG Phase II Study of TCAR in Malignant Glioma


    NCIC CTG Phase II Study of TCAR in Malignant Glioma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 18, 1990 Closing Date: May 28, 1991



    		Permanently Closed
    I162

    A Phase I Study Of Temozolomide And RAD001C In Patients With Malignant Glioma


    A Phase I Study Of Temozolomide And RAD001C In Patients With Malignant Glioma

    Eligibility: Patients with newly diagnosed (no prior chemotherapy permitted) or recurrent (only one prior adjuvant chemo regimen permitted), glioblastoma multiforme (GBM). Bidimensionally measurable disease. Stable dose of steroids. Paraffin embedded tumour sample available for study.

    Objectives: To assess the toxicity, pharmacokinetics, efficacy, MTD, and RPII dose(s) of RAD001C when given in combination with standard dose of Temozolomide in patients with GBM. Patients receiving enzyme inducing anti-epileptic drugs (EIAEDs) and those not receiving EIAEDs will be studied separately.

    NCT Registration ID (from clinicaltrials.gov): NCT00387400
    Participation: Participation in this study is restricted to invited centres.
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 25, 2006 Closing Date: June 01, 2009



    		Permanently Closed
    I109

    NCIC CTG Phase II Study of Topotecan in Patients With Anaplastic Oligodendroglioma or Anaplastic Mixed Oligoastrocytoma


    NCIC CTG Phase II Study of Topotecan in Patients With Anaplastic Oligodendroglioma or Anaplastic Mixed Oligoastrocytoma

    NCT Registration ID (from clinicaltrials.gov): NCT00003372
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: December 08, 1997 Closing Date: April 20, 2000



    		Permanently Closed
    I76

    NCIC CTG Phase II Study of Taxotere in Malignant Glioma


    NCIC CTG Phase II Study of Taxotere in Malignant Glioma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 04, 1994 Closing Date: April 28, 1995



    		Permanently Closed
    I94

    NCIC CTG Phase II Study of Gemcitabine in Patients With Malignant Glioma


    NCIC CTG Phase II Study of Gemcitabine in Patients With Malignant Glioma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: May 06, 1996 Closing Date: April 28, 1997



    		Permanently Closed
    I75

    NCIC CTG Phase II Study of Topotecan in Patients With Malignant Glioma


    NCIC CTG Phase II Study of Topotecan in Patients With Malignant Glioma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: September 08, 1992 Closing Date: January 25, 1994



    		Permanently Closed
    I13

    NCIC CTG Phase II Study of N-methylformamide in Glioma


    NCIC CTG Phase II Study of N-methylformamide in Glioma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: December 01, 1984 Closing Date: April 29, 1985



    		Permanently Closed
    I241D

    A Phase II Study of Lunresertib Plus Camonsertib in Patients With CDK4/6 Inhibitor Treated ER+/HER2- Metastatic Breast Cancer


    A Phase II Study of Lunresertib Plus Camonsertib in Patients With CDK4/6 Inhibitor Treated ER+/HER2- Metastatic Breast Cancer

    Complexity Level: 1

    Eligibility: Patients must meet the following criteria in addition to the eligibility criteria outlined in IND.241. Pts must not be deemed candidates for further standard endocrine therapies. Pts may have recevied a 2nd line endocrine therapy in combination with a targeted therapy, with or without a subsequent line of therapy with fulvestrant. Pts. may not have had prior treatment with a WEE inhibitor, DNA-PK, PKMYT1 inhibitor or ATR inhibitor. Pts. who cannot discontinue the use of proton pump inhibitors, strong CYP3A inhibitors or inducers, or strong P-gp or BCRP inhibitors are not eligible.

    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Planned



    		Planned
    I241

    A Liquid-biopsy Informed Platform Trial to Evaluate Treatment in CDK4/6-inhibitor Resistant ER+/HER2- Metastatic Breast Cancer

    The purpose of the pre-study screening is to test for biomarkers. The testing will be done using a sample of your blood. Patients will be sorted into one of the substudies, depending on eligibility and availability. Each substudy will be looking at what effects a new drug has on the patients and their breast cancer, as well as any side effects of the treatment. The purpose of each substudy is to see if the biomarkers that were identified at screening can be used to determine treatment outcomes, like how the cancer cells respond to treatment.

    A Liquid-biopsy Informed Platform Trial to Evaluate Treatment in CDK4/6-inhibitor Resistant ER+/HER2- Metastatic Breast Cancer

    Complexity Level: 1

    Eligibility: Patients (>=18yrs old, ECOG PS 0-1), life expectancy >=3 mo., must have advanced/metastatic ER+/HER2- breast cancer as per ASCO/CAP criteria that have objective progression on first line CDK4/6i+ET. One subsequent line of endocrine or target therapy is allowed. Pts may have received adjuvant/neoadjuvant systemic therapies; palliative cytotoxic chemotherapy is not permissible. All reversible prior toxicity related to prior therapies must have recovered to grade =<1 and have adequate washout. Measurable disease per RECIST 1.1. Consent to release of tissue block and biopsies. Women/men of childbearing potential must have agreed to use an effective contraceptive method. No history of other malignancies or uncontrolled /serious illnesses which would not permit the patient to be managed per protocol. Hypersensitivity to any of the study drug components. No CNS metastases. No pts who are unable to swallow oral meds/have impairment of GI function. No history of non-compliance.

    Objectives: Primary: Centrally genotype ctDNA from patients with CDK4/6i+ET resistant ER+/HER2- metastatic breast cancer and evaluate whether biomarker selection improves outcomes as assessed by RECIST 1.1 overall response rate (ORR), or for select studies, clinical benefit rate (CBR). Secondary: Evaluate safety and toxicity of each substudy drug and summarize progression free and overall survival. Exploratory: Create and maintain a tissue/data bank for patients undergoing screening for enrollment to a treatment substudy, evaluate changes in liquid biopsy ctDNA and CTCs as surrogates of treatment outcomes, evaluate potential biomarkers of response, resistance and progression through exploratory corelative studies.

    NCT Registration ID (from clinicaltrials.gov): NCT05601440
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Open to Accrual
    Activation Date: January 27, 2023



    		Open to Accrual
    I241C

    A Phase II Study of Niraparib, A PARP Inhibitor, in Patients with CDK4/6-Inhibitor Treated ER+/HER2- Metastatic Breast Cancer

    The purpose of this study is to test the good and bad effects of the drug called niraparib when receiving fulvestrant. The purpose of screening patients for a biomarker is to predict which patients are most likely to be helped by niraparib. To do this, a group of patients with or without a biomarker will be enrolled.

    A Phase II Study of Niraparib, A PARP Inhibitor, in Patients with CDK4/6-Inhibitor Treated ER+/HER2- Metastatic Breast Cancer

    Complexity Level: 1

    Eligibility: Patients must meet the following criteria in addition to the eligibility criteria outlined in IND.241. Patients may have received prior PARPi therapy, but only in the adjuvant setting provided the treatment-free interval is >12 moinths from date of completion of the PARPi. Patients must be eligible for secondline endocrine therapy with fulvestrant as standard of care. Patients must not have had prior history of PRES.

    Objectives: Primary: To centrally genotype ctDNA from patients with CDK4/6i-resistant ER+/HER2- metastatic breast cancer (MBC) and evaluate whether biomarker selection improves outcomes as assessed by RECIST 1.1 ORR.. To evaluate the safety and toxicity profile of Nirapirab with fulvestrant and to summarize progression free and overall survival. Exploratory: To evaluate changes in liquid biopsy ctDNA and CTCs as surrogates of treatment outcomes and to evaluate potential biomarkers of response, resistance and progression through exploratory correlative studies using ctDNA, CTCs, tissue-based analyses and radiomics.

    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Open to Accrual
    Activation Date: January 27, 2023



    		Open to Accrual
    I241A

    Liquid-Biopsy Monitoring for Patients not yet Eligible for Screening and Enrollment

    The purpose of this study is to monitor and follow your progress through your standard treatment. To do this, tumour tissue and blood samples will be tested for biomarkers, and imaging scans will be looked at to see how they are responding to standard treatment. If progression occurs (cancer gets wose) and the patient needs to start other treatment, the patient may be able to take part in the main treatment portion of the IND.241 trial.

    Liquid-Biopsy Monitoring for Patients not yet Eligible for Screening and Enrollment

    Complexity Level: 1

    Eligibility: Patients (>=18yrs old), life expectnacy >=3 mo., must have advanced/metastatic ER+/HER2- breast cancer as per ASCO/CAP criteria that are on or about to initiate active treatment with standard first-line therapy with a CDK4/6 inhibitor combined with an aromatase inhibitor.Pts. who have progressed on, or within 12 mo. of completion of adjuvant therapy with an aromatase inhibitor may be treated with fulvestrant instead of an aromatase inhibitor.. Measurable disease per RECIST 1.1. Consent to release of tissue block and biopsies. Not pregnant or breastfeeding. No history of other malignancies or uncontrolled /serious illnesses which would not permit the patient to be managed per protocol. Hypersensitivity to any of the study drug components. No CNS metastases. No pts who are unable to swallow oral meds/have impairment of GI function. No history of non-compliance.

    Objectives: Primary: To create and maintain a tissue and data bank including tumour and liquid biopsies and clinical data for patients receiving first line endocrine therapy plus CDK4/6i treatment. Exploratory: To evaluate potential biomarkers of response, resistance and progression through exploratorycorrelative studies using ctDNA and CTCs.

    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: CCTG Led Trial
    Status: Open to Accrual
    Activation Date: January 27, 2023



    		Open to Accrual
    I239

    A Phase II Study of CFI-400945 and Durvalumab in Patients with Advanced/Metastatic Triple Negative Breast Cancer (TNBC)


    A Phase II Study of CFI-400945 and Durvalumab in Patients with Advanced/Metastatic Triple Negative Breast Cancer (TNBC)

    Complexity Level: 1

    Eligibility: Histologically and/or cytologically confirmed diagnosis of breast cancer that is advanced/metastatic or unresectable and negative for ER, PR and HER2. FFPE tissue block available; select number of patients must have accessible disease suitable for biopsy. Presence of clinically/radiologically documented disease. ECOG 0 or 1. At least 1 prior line of cytotoxic chemotherapy for breast cancer, in any setting, must have included anthracycline and taxane. No limit to number of prior regimens. May have received other therapies (i.e. endocrine therapy, targeted therapies). Must not have received prior immunotherapy. Not permitted: Active or uncontrolled infections, active or prior autoimmune or inflammatory disorders, primary immunodeficiency or allogenic organ transplant, serious illness, untreated or uncontrolled cardiovascular conditions, history of CNS mets or spinal cord compression; concurrent treatment with other investigational drugs, treated with full dose warfarin or growth factors.

    Objectives: Primary Objectives: To evaluate the objective response rate (RECIST 1.1) of CFI-400945 given with durvalumab. Secondary Objectives: To evaluate Disease Control Rate (DCR, defined as CR or PR or stable disease (SD) > 16 weeks in duration) of CFI-400945 given with durvalumab, to evaluate the immune-related response rate (iRECIST) of CFI-400945 given with durvalumab, to establish the safety and tolerability of CFI-400945 given orally in combination with durvalumab in a q4w schedule and to confirm the recommended phase II dose (RP2D) in patients with metastatic triple negative breast cancer (TNBC), and to assess the pharmacodynamic and immune effects of CFI-400945+durvalumab.

    NCT Registration ID (from clinicaltrials.gov): NCT04176848
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Closed to Accrual
    Activation Date: December 19, 2019 Closing Date: April 26, 2022



    		Closed to Accrual
    I236

    A Phase Ib and Open Label Phase II Study of CFI-402257 in Combination with Weekly Paclitaxel in Patients with Advanced/Metastatic HER2-Negative Breast Cancer


    A Phase Ib and Open Label Phase II Study of CFI-402257 in Combination with Weekly Paclitaxel in Patients with Advanced/Metastatic HER2-Negative Breast Cancer

    Complexity Level: 1

    Eligibility: Histologically and/or cytologically confirmed diagnosis breast cancer that is advanced/metastatic/recurrent or unresectable. Formalin fixed paraffin embedded tissue block available; select number of patients in Phase II must have accessible disease suitable for biopsy. Presence of clinically and/or radiologically documented disease. ECOG 0 or 1. Must have received at least one non-taxane containing chemotherapy regimen for advanced/metastatic disease, unless:relapsed within 6 mos of completion of adjuvant chemo;taxane and/or anthracycline containing adjuvant chemo or;contraindications to chemo other than weekly paclitaxel. Patients may not have had previous TTK/MPS1 inhibitor.Patients with HER2 positive breast cancer not eligible; active or uncontrolled infections, serious illness, significant cardiac or pulmonary disease, history of central nervous system mets or spinal cord compression; concurrent treatment with other investigational drugs; patients treated with full dose warfarin

    Objectives: Primary: Phase I - To establish the safety and tolerability of CFI-402257 given orally in combination with weekly paclitaxel and to identify the recommended Phase II dose (RP2D) in patients with advanced breast cancer. Phase II: To evaluate the anti-tumour activity of the CFI-402257+Paclitaxel combination when administered at the RP2D by determining Overall Response Rate (ORR). Secondary: To estimate the Clinical Benefit Rate (CBR, defined as CR or PR or stable disease (SD) >16 weeks in duration; to evaluate the safety and tolerability; to explore, if indicated, the PK profile of CFI402257 and paclitaxel. Exploratory: in serial tumour biopsies, explore evidence of pharmacodynamic target effect and estimate CFI402257 levels; evaluate the genomic alterations and other molecular features which may be associated with response and/or clinical benefit

    NCT Registration ID (from clinicaltrials.gov): NCT03568422
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Closed to Accrual
    Activation Date: October 17, 2018 Closing Date: April 07, 2022



    		Closed to Accrual
    I237

    A Phase II Study of CFI-400945 in Patients with Advanced/Metastatic Breast Cancer


    A Phase II Study of CFI-400945 in Patients with Advanced/Metastatic Breast Cancer

    Complexity Level: 1

    Eligibility: Histologically and/or cytologically confirmed diagnosis breast cancer that is advanced/metastatic/recurrent or unresectable and either ER-, PR- and HER2- (COHORT 1) or ER+/PR+, HER2- and PTEN-null (COHORT 2) or ER+/PR+, HER2- and not PTEN-null (COHORT 3). FFPE tissue block available; select number of patients per cohort must have accessible disease suitable for biopsy. Presence of clinically/radiologically documented disease. ECOG 0 or 1. At least 1 prior line of cytotoxic chemotherapy for breast cancer, in any setting, must have included anthracycline and taxane (unless contraindicated). No limit to number of prior regimens. May have received other therapies (i.e. endocrine therapy, immunotherapy, targeted therapies). HER2+ breast cancer not eligible; active or uncontrolled infections, serious illness, significant cardiac or pulmonary disease, history of CNS mets or spinal cord compression; concurrent treatment with other investigational drugs; treated with full dose warfarin.

    Objectives: Primary: To evaluate the objective response rate of CFI-400945 in patients with unresectable locally recurrent or metastatic breast cancer. Secondary: To estimate the Disease Control Rate (DCR, defined as CR or PR or stable disease (SD) >16 weeks in duration; to evaluate the safety and tolerability; to evaluate pharmacodynamics and cellular effects on tumour cells through paired tumour biopsies. Tertiary: To evaluate somatic genomic alterations and other molecular features (gene or protein expression levels) associated with response and/prolonged stable disease; to evaluate the association between PTEN status and response; to explore mechanisms of acquired resistance to CFI-400945 and clonal evolution in response to CFI-400945 treatment using cfDNA.

    NCT Registration ID (from clinicaltrials.gov): NCT03624543
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Closed to Accrual
    Activation Date: December 21, 2018 Closing Date: January 17, 2023



    		Closed to Accrual
    I241B

    A Phase II Study of RP-6306 in Patients with CDK4/6-Inhibitor Treated ER+HER2- Metastatic Breast Cancer Receiving Gemcitabine


    A Phase II Study of RP-6306 in Patients with CDK4/6-Inhibitor Treated ER+HER2- Metastatic Breast Cancer Receiving Gemcitabine

    Complexity Level: 1

    Eligibility: Patients must meet the following criteria in addition to the eligibility criteria outlined in IND.241. Pts. must have exhausted all standard endocrine therapies including standard fulvestrant. Must not have had prior treatemt with a WEE1 inhibitor, PKMYT1 inhibitor or gemcitabine. Mean resting QTcF =<450 msec/male and =<470 msec/female. Cannot be receiving treatment with medications that prolong the QT interval and/or strong CYP3A inhibitors or inducers within 14 days prior to first dose of study treatment.

    Objectives: Primary: To centrally genotype ctDNA from patients with CD4/6i-resistant ER+/HER2- metastatic breast cancer (MBC) and evaluate whether biomarker selection improves outcoems as assessed by RECIST 1.1 ORR. Secondary: To evaluate the safety and toxicity profile of RP-6306 with gemcitabine and to summarize progression free and overall survival. Exploratory Objectives: To evlauate changes in liquid bioposy ctDNA and CTCs as surrogates of treatment outcomes and to evaluate potential biomarkers of response, resistance and progression through exploatory correlative studies using ctDNA, CTCs, tissue-based analyses and radiomics.

    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Closed to Accrual
    Activation Date: January 27, 2023 Closing Date: September 10, 2024



    		Closed to Accrual
    I19

    NCIC CTG Phase II Study of Menogaril in Breast


    NCIC CTG Phase II Study of Menogaril in Breast

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: May 30, 1985 Closing Date: March 15, 1986



    		Permanently Closed
    I132

    A Phase II Study of Temozolomide Given in a 7 Days On, 7 Days Off Oral Schedule Every 4 Weeks to Patients with Advanced Breast Cancer


    A Phase II Study of Temozolomide Given in a 7 Days On, 7 Days Off Oral Schedule Every 4 Weeks to Patients with Advanced Breast Cancer

    Eligibility: Women with histologically documented advanced or metastatic breast cancer. Clinically and/or radiologically assessable disease. Unidimensional measurable disease. Prior adjuvant chemotherapy and/or up to two prior chemotherapy regimens for metastatic disease permitted.

    Objectives: To assess the efficacy (measured by objective tumour response) of temozolomide when given in this schedule in this patient population. To determine the duration of response, time to progression and the toxic effects of temozolomide when administered in this fashion.

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 01, 2000 Closing Date: September 26, 2001



    		Permanently Closed
    I35

    NCIC CTG Phase II Study of CMF/Lonidamine in Breast


    NCIC CTG Phase II Study of CMF/Lonidamine in Breast

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: December 08, 1986 Closing Date: January 08, 1988



    		Permanently Closed
    I68

    NCIC CTG Phase II Study of Taxotere in Patients With Metastatic Breast Cancer


    NCIC CTG Phase II Study of Taxotere in Patients With Metastatic Breast Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 01, 1992 Closing Date: June 30, 1993



    		Permanently Closed
    I197

    A Phase II Study of Foretinib in Patients with Estrogen Receptor (ER), Progesterone Receptor (PR), and Human Epidermal Growth Factor Receptor 2 (HER2) Negative, Recurrent/Metastatic Breast Cancer.


    A Phase II Study of Foretinib in Patients with Estrogen Receptor (ER), Progesterone Receptor (PR), and Human Epidermal Growth Factor Receptor 2 (HER2) Negative, Recurrent/Metastatic Breast Cancer.

    Complexity Level: 2

    Eligibility: Advanced or recurrent/metastatic invasive breast cancer, that is ER, PR and HER2 negative.

    Objectives: To determine the anti-tumour activity and toxicity of foretinib in this patient population.

    NCT Registration ID (from clinicaltrials.gov): NCT01147484
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: May 25, 2010 Closing Date: August 02, 2013



    		Permanently Closed
    I18

    NCIC CTG Phase II Study of Flutamide in Breast


    NCIC CTG Phase II Study of Flutamide in Breast

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: March 27, 1985 Closing Date: March 01, 1986



    		Permanently Closed
    I198

    A Phase I/II Study of Foretinib in Combination with Lapatinib in Patients with Human Epidermal Growth Factor Receptor 2(HER2)Over-Expressing Metastatic Breast Cancer


    A Phase I/II Study of Foretinib in Combination with Lapatinib in Patients with Human Epidermal Growth Factor Receptor 2(HER2)Over-Expressing Metastatic Breast Cancer

    Complexity Level: 1

    Eligibility: Histologically confirmed diagnosis of invasive breast cancer, that is HER2 positive as assessed by FISH or ICH 3+ staining (in accordance with ASCO guidelines) on the basis of local evaluation of HER2 status.

    Objectives: To determine the recommended phase II dose (RP2D) of foretinib in combination with lapatinib, administered as a continuous daily oral dose, in patients with recurrent or metastatic HER2+ breast cancer. To evaluate the PK of lapatinib when given in combination with foretiib, preliminary evidence of anti-tumour activity, and to investigate the relationship between biomarkers and response.

    NCT Registration ID (from clinicaltrials.gov): NCT01138384
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 03, 2010 Closing Date: March 05, 2013



    		Permanently Closed
    I213

    A Randomized Phase II Study of Reolysin For Patients Receiving Standard Weekly Paclitaxel Therapy as Therapy For Advanced/Metastatic Breast Cancer


    A Randomized Phase II Study of Reolysin For Patients Receiving Standard Weekly Paclitaxel Therapy as Therapy For Advanced/Metastatic Breast Cancer

    Complexity Level: 2

    Eligibility: Patients with histoligical/cytological diagnosis of metastatic breast cancer, that is advanced and/or metastatic, with no curative therapy and for which systemic therapy is indicated. Tumour block available. Patients must have measurable disease as defined by RECIST 1.1. Patients must have received at least one prior chemotherapy regimen for advanced or metastatic disease, unless they have relapsed within 6 months of completion of adjuvant chemotherapy or they have received taxane and/or anthracycline containing adjuvant chemotherapy. ECOG 0-2. No neuropathy > grade 1.

    Objectives: Primary Objective: To evaluate the effect of reolysin in combination with standard paclitaxel chemotherapy on the progression free survival of patients with advanced or metastatic breast cancer Secondary Objectives: a) to determine the tolerability and toxicity of reolysin and paclitaxel when given in combination. b) to investigate additional potential measures of efficacy including: objective response rate, overall survival, CTC counts c) to explore potential molecular factors predictive of response by assessment of archival tumour tissue and CTCs, including EGFR and KRAS status.

    NCT Registration ID (from clinicaltrials.gov): NCT01656538
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 30, 2012 Closing Date: April 20, 2016



    		Permanently Closed
    I60

    NCIC CTG Phase II Study of 10-EDAM in Patients With Metastatic Breast Cancer


    NCIC CTG Phase II Study of 10-EDAM in Patients With Metastatic Breast Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: October 29, 1990 Closing Date: September 17, 1991



    		Permanently Closed
    I93

    NCIC CTG Randomized Phase II Study of High-Dose Paclitaxel With or Without Amifostine in Patients With Metastatic Breast Cancer


    NCIC CTG Randomized Phase II Study of High-Dose Paclitaxel With or Without Amifostine in Patients With Metastatic Breast Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 24, 1996 Closing Date: September 24, 1998



    		Permanently Closed
    I129

    A Phase II Study of ZD0473 Given as a Short Infusion Every 3 Weeks to Patients With Advanced or Metastatic Breast Cancer


    A Phase II Study of ZD0473 Given as a Short Infusion Every 3 Weeks to Patients With Advanced or Metastatic Breast Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 14, 2000 Closing Date: March 02, 2001



    		Permanently Closed
    I229

    A Phase 1b Pharmacodynamic Study of Durvalumab (MEDI4736) in Patients with HER-2 Positive Metastatic Breast Cancer (MBC) Receiving Trastuzumab


    A Phase 1b Pharmacodynamic Study of Durvalumab (MEDI4736) in Patients with HER-2 Positive Metastatic Breast Cancer (MBC) Receiving Trastuzumab

    Complexity Level: 1

    Eligibility: Patients with histologically and/or cytologically confirmed HER-2 positive metastatic breast cancer. Must have an available formalin fixed paraffin embedded tissue block from primary or metastatic tumour. Patients enrolled to the RP2D / expansion cohort must have accessible disease suitable for biopsy and have consented to biopsy prior to treatment and at the end of cycle 1 (paired biopsies are recommended in all patients). Patients must have measurable disease per RECIST 1.1 and adequate organ function. Age >=18 years. ECOG 0, 1, or 2. Must have had prior exposure to a taxane, trastuzumab and pertuzumab and preferably also prior exposure to TDM-1 (no limit to number of prior regimens). Prior surgery and radiation permitted provided adequate time has elapsed form last dose. No active or prior autoimmune or inflammatory disorders, or history of primary immunodeficiency. No live attenuated vaccination on treatment or within 30 days of either registration or last dose.

    Objectives: PRIMARY - To determine the recommended phase II dose of durvalumab given to patients with advanced/recurrent HER-2 positive metastatic breast cancer (MBC) who are receiving treatment with trastuzumab. SECONDARY - (1) To describe the toxicities of durvalumab in patients receiving trastuzumab; (2) To evaluate the response rate and clinical benefit rate of durvalumab (measured by RECIST 1.1/Immune Response Criteria) in patients receiving trastuzumab; (3) To assess PD-L1 expression in paired biopsies pre and post treatment with durvalumab as a marker of response/benefit. EXPLORATORY - (1) To perform whole exome sequencing and RNAseq in paired biopsies (pre and post treatment) to explore biological correlates relative to PD-1/PD-L1 and trastuzumab and durvalumab exposure (minimum of 6 patients with paired biopsies); (2) To collect ctDNA as an exploratory marker; (3) To assess T cell and other immune cell subsets in paired biopsies pre and post treatment.

    NCT Registration ID (from clinicaltrials.gov): NCT02649686
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Permanently Closed
    Activation Date: April 21, 2016 Closing Date: April 20, 2017



    		Permanently Closed
    I97

    NCIC CTG Phase II Study of DPPE/Doxorubicin Chemotherapy in Metastatic Breast Cancer


    NCIC CTG Phase II Study of DPPE/Doxorubicin Chemotherapy in Metastatic Breast Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: May 10, 1996 Closing Date: January 06, 1998



    		Permanently Closed
    I73

    NCIC CTG Phase II Study of the Progesterone Antagonist Mifepristone (RU486) in Metastatic Breast Cancer


    NCIC CTG Phase II Study of the Progesterone Antagonist Mifepristone (RU486) in Metastatic Breast Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 27, 1992 Closing Date: February 28, 1995



    		Permanently Closed
    I163

    A Randomized Phase II Study of Two Different Schedules of RAD001C in Patients With Recurrent/Metastatic Breast Cancer


    A Randomized Phase II Study of Two Different Schedules of RAD001C in Patients With Recurrent/Metastatic Breast Cancer

    Eligibility: Patients with recurrent or metastatic breast cancer incurable by other means. Prior adjuvant as well as up to one prior regimen for recurrent/metastatic disease is permitted. Measurable disease. Paraffin embedded tumour sample available for study.

    Objectives: To evaluate, in parallel, the anti-tumour efficacy of two oral treatment schedules of RAD001C. To assess the adverse events, time to progression and response duration of RAD001C in patients with recurrent/metastatic breast cancer.

    NCT Registration ID (from clinicaltrials.gov): NCT00255788
    Participation: Participation in this study is restricted to invited centres.
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 19, 2005 Closing Date: January 11, 2007



    		Permanently Closed
    I164

    A Phase II Study of a Second Generation Clusterin Antisense Oligonucleotide (OGX-011) in Combination With Docetaxel in Advanced Breast Cancer


    A Phase II Study of a Second Generation Clusterin Antisense Oligonucleotide (OGX-011) in Combination With Docetaxel in Advanced Breast Cancer

    Eligibility: Women with histologically documented breast cancer with metastatic or locally disease refractory to standard curative therapy. Prior adjuvant chemotherapy permissible; up to one prior chemotherapy regimen for metastatic disease and no prior taxane for metastatic disease. Prior hormonal therapy permitted, prior radiation therapy permitted if radiation involved <30% functioning bone marrow and >4 weeks. HER-2 positive patients may have had prior Herceptin treatment. ECOG 0,1,2. No brain metastases, no pre-existing neuropathy >= grade 2, no therapeutic anti-coagulation.

    Objectives: To determine the efficacy, as measured by objective tumour response rate, of weekly OGX-011 and q 3 weekly docetaxel when given in combination to patients with advanced breast cancer. To assess the adverse events, tolerability, time to progression and overall survival in this population. To measure evidence of OGX-011 effect on serum clusterin levels.

    NCT Registration ID (from clinicaltrials.gov): NCT00258375
    Participation: CAKO, CALM, CAMN, CAMP, CANL, CAVA, CAVF, CAVK
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 27, 2005 Closing Date: September 29, 2006



    		Permanently Closed
    I45

    NCIC CTG Phase II Study of Oral Menogaril in Breast Cancer


    NCIC CTG Phase II Study of Oral Menogaril in Breast Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 27, 1989 Closing Date: April 15, 1990



    		Permanently Closed
    I4B

    NCIC CTG Phase II Study of Lonidamine in Breast Cancer


    NCIC CTG Phase II Study of Lonidamine in Breast Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: October 01, 1983 Closing Date: May 13, 1985



    		Permanently Closed
    I90

    NCIC CTG Phase II Study of LY231514 in Patients With Locally Advanced/Metastatic Colorectal Cancer


    NCIC CTG Phase II Study of LY231514 in Patients With Locally Advanced/Metastatic Colorectal Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: September 12, 1995 Closing Date: June 21, 1996



    		Permanently Closed
    I187

    A Phase I Study Of AZD2281 In Combination With Irinotecan In Patients With Locally Advanced or Metastatic Incurable Colorectal Cancer


    A Phase I Study Of AZD2281 In Combination With Irinotecan In Patients With Locally Advanced or Metastatic Incurable Colorectal Cancer

    Complexity Level: 1

    Eligibility: Patients with histologically or cytologically documented colorectal cancer and must have locally advanced and/or metastatic colorectal cancer that is considered incurable and suitable for treatment with single agent irinotecan as a palliative intervention by the investigator. No anti-cancer treatment <= 21 days. ECOG 0, 1 or 2. Adequate cardiac function and acceptable end-organ function. No GI tract disease resulting in an iability to adsorb oral medication.

    Objectives: 1.1 To determine the recommended phase II dose of irinotecan given on day 1 by 90 minute infusion every 21 days with a biologically active dose of AZD2281 given orally bid continuously, in patients with locally advanced or metastatic incurable colorectal cancer. 1.2 To determine the safety, tolerability, toxicity profile, dose limiting toxicities and pharmacokinetic profile of the combination of AZD2281 and irinotecan in this schedule. The correlation, if any, between the toxicity profile and the pharmacokinetics will be determined. 1.3 To assess preliminary evidence of the anti-tumour activity of AZD2281 in combination with irinotecan in patients with colorectal cancer with measurable disease. 1.4 To demonstrate the pharmacodynamic activity of AZD2281 in combination with irinotecan by establishing its effects in tumour biopsies, cheek swabs and blood samples. 1.5 To assess the correlation, if any, between patients with tumours demonstrating microsatellite instability and anti-tu

    NCT Registration ID (from clinicaltrials.gov): NCT00535353
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 13, 2007 Closing Date: March 08, 2012



    		Permanently Closed
    I98

    NCIC CTG Phase I/II Study of Tomudex and Doxorubicin in Patients With Locally Advanced, Inoperable or Metastatic Gastric Cancer


    NCIC CTG Phase I/II Study of Tomudex and Doxorubicin in Patients With Locally Advanced, Inoperable or Metastatic Gastric Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: October 24, 1996 Closing Date: April 07, 1999



    		Permanently Closed
    I210

    A Randomized Phase II Study of Reolysin in Combination with FOLFOX6 and Bevacizumab or FOLFOX6 and Bevacizumab Alone in Patients with Metastatic Colorectal Cancer.


    A Randomized Phase II Study of Reolysin in Combination with FOLFOX6 and Bevacizumab or FOLFOX6 and Bevacizumab Alone in Patients with Metastatic Colorectal Cancer.

    Complexity Level: 2

    Eligibility: Patients with a histological diagnosis of metastatic colorectal adenocarcinoma. Tumour block available. Patients must have measurable disease as defined by RECIST 1.1. No prior chemotherapy for metastatic disease. Prior adjuvant fluropyrimidine based therapy is permitted >= 12 months prior to enrollment. ECOG 0, 1 or 2. Adequate end-organ function. No neuropathy > grade1

    Objectives: 1. To evaluate the effect of reolysin in combination with standard FOLFOX6 chemotherapy of the progression free survival of patients with advanced or metastatic colorectal cancer. 2a. To determine the tolerability and toxicity of reolysin and FOLFOX6/Bevacizumab when given in combination. 2b. To investigate additional potential measures of efficacy including:change in CEA levels; objective response rate; evaluate the effect of both treatments on overall survival (OS) 2c.To explore potential molecular factors that may be prognostic or predictive of response by assessment of archival tumour tissue and serial blood samples 2d.To explore the Quality of Life (as measured by the EORTC QLQC30)

    NCT Registration ID (from clinicaltrials.gov): NCT01622543
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 11, 2012 Closing Date: February 12, 2015



    		Permanently Closed
    I1C

    NCIC CTG Phase II Study of Acivicin (AT125) in Colorectal Cancer


    NCIC CTG Phase II Study of Acivicin (AT125) in Colorectal Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: November 03, 1981 Closing Date: May 31, 1982



    		Permanently Closed
    I135

    A Phase I/II Study Of CPT-11 (Irinotecan), Oxaliplatin and Raltitrexed (COT) in Patients With Advanced Colorectal Cancer


    A Phase I/II Study Of CPT-11 (Irinotecan), Oxaliplatin and Raltitrexed (COT) in Patients With Advanced Colorectal Cancer

    Eligibility: Histologically documented colon or rectal cancer that is metastatic or locally recurrent.

    Objectives: To determine the maximum tolerated dose (MTD) and recommended phase II dose of COT given as intravenous infusions on day 1 every 3 weeks. To determine the toxic effects of COT. To determine the pharmacokinetics IF the toxicity of the combined regimen is not in keeping with the toxicity expected from single or double agent studies. To assess clinical response rates of the combination.

    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 28, 2000 Closing Date: February 07, 2002



    		Permanently Closed
    I8

    NCIC CTG Phase II Study of N-methylformamide in Colon


    NCIC CTG Phase II Study of N-methylformamide in Colon

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: December 14, 1984 Closing Date: April 29, 1985



    		Permanently Closed
    I168

    A Phase II Study of SB-715992 (NSC 727990) in Patients With Locally Advanced, Recurrent or Metastatic Hepatocellular Carcinoma


    A Phase II Study of SB-715992 (NSC 727990) in Patients With Locally Advanced, Recurrent or Metastatic Hepatocellular Carcinoma

    Eligibility: Patients with histologically or cytologically documented hepatocellular carcinoma with locally advanced, recurrent or metastatic disease. Unidimensionally measurable disease by RECIST criteria. Prior intra-hepatic chemotherapy permitted; no prior systemic chemotherapy permitted. Patients must be > 4 weeks since major surgery, radiation therapy, local ablative therapy or intra-hepatic chemotherapy and must have hepatic reserve of Child-Turcotte-Pugh Class A or better. Patients with histological diagnosis must have archival tumour specimen available for correlative study.

    Objectives: To assess the efficacy (response rate and stable disease rate) of SB-715992 given by 1 hour intravenous infusion once every 3 weeks in patients with locally advanced, recurrent or metastatic hepatocellular carcinoma. To assess the toxicity of SB-715992 in patients with locally advanced, recurrent or metastatic hepatocellular carcinoma, as well as early progression rate, and, if responses are observed, response duration. To characterize the population pharmacokinetic (PK) parameters of SB-715992 including an assessment of significant covariates on SB-715992 PK and an assessment of the potential relationships between the pharmacokinetics of SB-715992 and relevant safety and efficacy endpoints. To describe the relationship between tumour expression of B-tubulin and KSP in archival paraffin fixed tumour tissue with clinical outcome of treatment with SB-715992. In a subset of separately consenting patients, to describe the changes in molecular markers of SB-715992 effect in PBMCs.

    NCT Registration ID (from clinicaltrials.gov): NCT00095992
    Participation: Limited to invited centres only.
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: November 24, 2004 Closing Date: May 04, 2006



    		Permanently Closed
    I171

    A Phase I, Open-Label, Dose-Seeking Study of AZD2171 Given Daily Orally in Combination with Standard Chemotherapy Regimens (CT) in Patients with Advanced Incurable Non-Small Cell Lung Cancer (NSCLC) or Colorectal Cancer or Other Tumour Types Suitable for Treatment with Capecitabine


    A Phase I, Open-Label, Dose-Seeking Study of AZD2171 Given Daily Orally in Combination with Standard Chemotherapy Regimens (CT) in Patients with Advanced Incurable Non-Small Cell Lung Cancer (NSCLC) or Colorectal Cancer or Other Tumour Types Suitable for Treatment with Capecitabine

    Eligibility: Histologically/cytologically documented advanced and/or metastatic NSCLC or colorectal cancer or other tumour types with clinically/radiologically documented disease. At least 6 months since prior adjuvant or neoadjuvant chemotherapy; prior adjuvant radiotherapy provided it was completed at least 6 months prior to registration; 14 days since major surgery; no prior therapy with angiogenesis inhibitor. For NSCLC: maximum of 1 prior single agent non-platinum chemotherapy for metastatic disease; no prior taxane therapy; no peripheral neuropathy > grade 1. For colorectal: suitable for first line therapy with capecitabine; not eligible with DPD deficiency or severe hand-foot syndrome from fluoropyrimidines. For other tumour types: suitable for treatment with capecitabine; patients with no more than 2 prior chemotherapy; LVEF >50% if prior anthracyclines/trastuzumab/cardiotoxic agents; not eligible with DPD deficiency or severe hand-foot syndrome from fluoropyrimidines.

    Objectives: To determine the recommended phase II dose of AZD2171 when given orally daily in combination with standard chemotherapy in patients with advanced NSCLC or colon cancer or other tumour types suitable for treatment with capecitabine and to determine the safety, tolerability, toxicity profile, dose limiting toxicities and pharmacokinetic profile of AZD2171 and standard chemotherapy given in these combinations. Also to assess the anti-tumour activity of AZD2171 in patients with measurable disease and to correlate patient outcomes (response) with baseline (tumour) and serial (urine and plasma) biomarkers.

    NCT Registration ID (from clinicaltrials.gov): NCT00107250
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 13, 2005 Closing Date: February 17, 2009



    		Permanently Closed
    I23

    NCIC CTG Phase II Study of Acivicin in Colon


    NCIC CTG Phase II Study of Acivicin in Colon

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: September 17, 1985 Closing Date: April 28, 1986



    		Permanently Closed
    I175

    A Phase I, Open-Label, Dose-Seeking Study of AZD2171 Given Daily Orally in Combination With Selected Standard Chemotherapy Regimens (CT) in Patients With Advanced Incurable Non-Small Cell Lung Cancer (NSCLC) or Colorectal Cancer


    A Phase I, Open-Label, Dose-Seeking Study of AZD2171 Given Daily Orally in Combination With Selected Standard Chemotherapy Regimens (CT) in Patients With Advanced Incurable Non-Small Cell Lung Cancer (NSCLC) or Colorectal Cancer

    Eligibility: Histologically/cytologically documented advanced and/or metastatic NSCLC or colorectal cancer with clinically/radiologically documented disease. At least 6 months since prior adjuvant or neoadjuvant chemotherapy; prior adjuvant radiotherapy provided it was completed at least 6 months prior to registration; at least 14 days since major surgery; no prior therapy with angiogenesis inhibitor. ECOG PS of 0,1 OR 2. No uncontrolled hypertension or CVD. No peripheral neuropathy > grade 1. Adequate bone marrow reserve and renal and liver function. For NSCLC: maximum of one prior single agent non-platinum chemotherapy for metastatic disease; no prior gemcitabine therapy. For colorectal: suitable for first line therapy with FOLFOX-6; no prior oxaliplatin patients with DPD deficiency or history of severe hand- foot syndrome from fluoropyrimidines are not eligible.

    Objectives: To determine the recommended phase II dose of AZD2171 when given orally daily in combination with standard chemotherapy in patients with advanced NSCLC or colorectal cancer. To determine the safety, tolerability, toxicity profile, dose limiting toxicities and pharmacokinetic profile of AZD2171 and standard chemotherapy given in these combinations. The correlation, if any, between the toxicity profile and the pharmacokinetics will be determined. To assess the anti-tumour activity of AZD2171 in combination with standard chemotherapy regimens in patients with measurable disease.

    NCT Registration ID (from clinicaltrials.gov): NCT00343408
    Participation: Limited to invited centres.
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 08, 2005 Closing Date: March 30, 2007



    		Permanently Closed
    I146

    A Phase II Study of Second-Line SarCNU (NSC 364432) in Patients With Recurrent/Metastatic Colorectal Cancer


    A Phase II Study of Second-Line SarCNU (NSC 364432) in Patients With Recurrent/Metastatic Colorectal Cancer

    Eligibility: Histologically proven colorectal cancer, either locally recurrent or metastatic following first-line chemotherapy for recurrent/metastatic disease. Clinically or radiological documented unidimensional measurable disease (RECIST criteria). Must have received one previous chemotherapy regimen for recurrent/metastatic disease. Prior nitrosourea not permitted.

    Objectives: To determine the efficacy of SarCNU given orally on days 1, 5 and 9 every 6 weeks in patients with recurrent/metastatic colorectal cancer. To determine time to progression, survival and qualitative and quantitative toxicity of SarCNU in this schedule in this patient population. Laboratory correlative studies will also be done.

    NCT Registration ID (from clinicaltrials.gov): NCT00028015
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: October 30, 2001 Closing Date: August 14, 2003



    		Permanently Closed
    I58

    NCIC CTG Phase II Study of DuP 937 in Patients With Colorectal Cancer


    NCIC CTG Phase II Study of DuP 937 in Patients With Colorectal Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 04, 1991 Closing Date: November 10, 1991



    		Permanently Closed
    I173

    A Phase I/II Study Of AZD0530 In Combination With Gemcitabine In Patients With Advanced Pancreatic Cancer


    A Phase I/II Study Of AZD0530 In Combination With Gemcitabine In Patients With Advanced Pancreatic Cancer

    Eligibility: Patients with unresectable, locally advanced or metastatic pancreatic cancer. No prior chemo therapy permitted except for 5FU(+/-folinic acid) or gemcitabine given concurrently with radiation.

    Objectives: To determine the toxicity and RPII dose of AZD0530 when given in combination with Gemcitabine in patients with pancreatic cancer. To assess the efficacy of AZD0530 in combination with Gemcitabine in patients with pancreatic cancer.

    NCT Registration ID (from clinicaltrials.gov): NCT00265876
    Participation: Participation is limited to invited centres only.
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 19, 2005 Closing Date: May 29, 2008



    		Permanently Closed
    I9

    NCIC CTG Phase II Study of TCAR in Colon


    NCIC CTG Phase II Study of TCAR in Colon

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: May 01, 1985 Closing Date: March 05, 1986



    		Permanently Closed
    I208

    Phase I/II Study of the P13Kinase Inhibitor BKM120 Given in Combination with Panitumumab in Patients with Metastatic or Advanced RAS-Wild Type Colorectal Cancer.


    Phase I/II Study of the P13Kinase Inhibitor BKM120 Given in Combination with Panitumumab in Patients with Metastatic or Advanced RAS-Wild Type Colorectal Cancer.

    Complexity Level: 1

    Eligibility: Patients with histologic proof of a primary colorectal cancer which is recurrent or metastatic. Tumour must be K-Ras wild type by means of mutation analysis and patient must have a representative sample of tumour tissue available. Patient must have failed, or have been unable to receive prior irinotecan, oxaliplatin and thymidylate synthase inhibitor therapy. Phase I-patients may have measureable or non-measurable disease. Phase II-patients must have measureable disease. At least 4 weeks since major surgery, chemotherapy, investigational agent or radiation therapy. ECOG 0-2. Age > 18 years.

    Objectives: Phase I-To determine the recommended phase II dose of BKM120 in combination with standard panitumumab therapy and determine the safety, tolerability, toxicity profile and dose limiting toxicities. Phase II-To assess the anti-tumour activity as evidenced by response rates and early progression and investigate the correlation, if any, between response and molecular biomarkers in archival FFPE tumour.

    NCT Registration ID (from clinicaltrials.gov): NCT01591421
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: May 01, 2012 Closing Date: July 14, 2015



    		Permanently Closed
    I112

    NCIC CTG Randomized Phase II Study of CGP 64128A (ISIS 3521) and CGP 69846A (ISIS 5132) in Locally Advanced or Metastatic Colorectal Cancer


    NCIC CTG Randomized Phase II Study of CGP 64128A (ISIS 3521) and CGP 69846A (ISIS 5132) in Locally Advanced or Metastatic Colorectal Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: March 11, 1998 Closing Date: September 29, 1999



    		Permanently Closed
    I234D

    A Phase II Study of CFI-400945 Fumarate in Metastatic Castration-Resistant Prostate Cancer (mCRPC)


    A Phase II Study of CFI-400945 Fumarate in Metastatic Castration-Resistant Prostate Cancer (mCRPC)

    Complexity Level: 1

    Eligibility: Patients must meet the following criteria in addition to the eligibility criteria outlined in IND.234. All patients must have a formalin fixed paraffin embedded tissue block (from primary or metastatic tumour) available and must have provided informed consent for the release of the block.

    Objectives: Primary Objectives To determine the effect of CFI-400945 on PSA decline and time to PSA progression. To determine objective response as determined by RECIST 1.1 criteria. Tertiary Objectives To obtain cfDNA and non-malignant DNA from peripheral blood clinically annotated with patient disease characteristics and follow-up data to identify potential predictive and prognostic factors and relationship between cfDNA results with clinical presentation. To evaluate the safety and toxicity profile of CFI-400945 in mCRPC patients.

    NCT Registration ID (from clinicaltrials.gov): NCT03385655
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: CCTG Led Trial
    Status: Closed to Accrual
    Activation Date: March 18, 2019 Closing Date: December 20, 2022



    		Closed to Accrual
    I234G

    A Phase II Study of Carboplatin in Patients with Metastatic Castration-Resistant Prostate Cancer


    A Phase II Study of Carboplatin in Patients with Metastatic Castration-Resistant Prostate Cancer

    Complexity Level: 1

    Eligibility: Patients must fulfill all of the criteria set out in Section 4.0 of the main protocol AND the following eligibility/ineligibility criteria and timings specific to carboplatin to be eligible for enrollment to the substudy. Renal function defined by serum creatinine < 1.25 x ULN and creatinine clearance >/= 50 mL/min. Patients who have a severe allergic reaction to platinum-containing compounds, who had live attenuated vaccination administered within 30 days prior to enrollment or within 30 days of receiving carboplatin, or need for concomitant treatment with nephrotoxic drugs are not eligible.

    Objectives: To determine the effect of carboplatin on PSA decline and time to PSA progression. To determine objective response as determined by RECIST 1.1 criteria. To summarize progression free and overall survival. To evaluate the safety and toxicity profile of carboplatin in mCRPC patients. To obtain cfDNA and non-malignant DNA from peripheral blood clinically annotated with patient disease characteristics and follow-up data to identify potential predictive and prognostic factors and relationship between cfDNA results with clinical presentation.

    NCT Registration ID (from clinicaltrials.gov): NCT03385655
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: CCTG Led Trial
    Status: Closed to Accrual
    Activation Date: June 10, 2020 Closing Date: February 27, 2024



    		Closed to Accrual
    I234F

    A Phase II Study of Durvalumab and Tremelimumab in Metastatic Castration-Resistant Prostate Cancer


    A Phase II Study of Durvalumab and Tremelimumab in Metastatic Castration-Resistant Prostate Cancer

    Complexity Level: 1

    Eligibility: Patients must meet the following criteria in addition to the eligiblity criteria outlined in IND.234. Patients must not have received prior immune checkpoint inhibitors (anti-PD-(L)1 and/or anti CTLA-4). Patients may not have active or prior documented autoimmune or inflammatory disorders, systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome, rheumatoid arthritis, hypophysitis, uveitis, etc. within the past 3 years except alopecia, Grave's disease vitiligo or psoriasis not requiring systemic treatment within the last 2 years, or hypothyroidism stable on hormone replacement. Patients must not have live attenuated vaccination administered within 30 days prior to enrollment or within 30 days of receiving durvalumab.

    Objectives: To determine the effect of durvalumab and tremelimumab on PSA decline and time to PSA progression. To determine objective response as determined by iRECIST criteria. To evaluate the safety and toxicity profile of durvalumab and tremelimumab in mCRPC patients. To obtain cfDNA and non-malignant DNA from peripheral blood clinically annotated with patient disease characteristics and follow-up data to identify potential predictive and prognostic factors and relationship between cfDNA results with clinical presentation.

    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Closed to Accrual
    Activation Date: December 27, 2019 Closing Date: February 27, 2024



    		Closed to Accrual
    I234E

    A Phase II Study of Ipatasertib in Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients with PI3K Pathway Alterations in Circulating Tumour DNA (ctDNA)


    A Phase II Study of Ipatasertib in Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients with PI3K Pathway Alterations in Circulating Tumour DNA (ctDNA)

    Complexity Level: 1

    Eligibility: Patients must meet the following criteria in addition to the eligiblity criteria outlined in IND.234. Patients must have adequate hematologic and organ function (AST <= 1.5 x ULN, fasting glucose <= 8.3 mmol/L, glycated hemoglobin <= 7.5%, serum albumin >= 3.0 g/L). Patients with Type 1 or Type 2 diabetes mellitus requiring insulin at study entry must be on a stable dose of diabetes medication for >=4 weeks. Patients must not have uncontrolled/untreated hypercholesterolemia or hypertriglyceridemia, require chronic therapy or use of food supplements that are strong CYP3A4/5 inducers or inhibitors or sensitive substrates of CYL3A or CYP2D6 with a narrow therapeutic window, or prior treatment with therapeutics with known inhibition of the PI3K pathway (including PI3K inhibitors, AKT inhibitors, and mTOR inhibitors).

    Objectives: To determine the effect of ipatasertib on PSA decline and time to PSA progression. To determine objective response as determined by RECIST 1.1 criteria. To evaluate the safety and toxicity profile of ipatasertib in mCRPC patients.

    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: CCTG Led Trial
    Status: Closed to Accrual
    Activation Date: December 27, 2019 Closing Date: February 27, 2024



    		Closed to Accrual
    I223

    A Phase II Study of Palbociclib, A CDK4/6 Inhibitor, in Patients with Metastatic Castration-Resistant Prostate Cancer


    A Phase II Study of Palbociclib, A CDK4/6 Inhibitor, in Patients with Metastatic Castration-Resistant Prostate Cancer

    Complexity Level: 1

    Eligibility: Patients (>=18 years old, ECOG PS 0-1) must have histologically confirmed mCRPC with no evidence of small cell/neuroendocrine differentiation. Patients will be pre-screened for CCDN1 amplification and RB1 status. Clinically/radiologically documented disease (measurable or non-measurable). Evidence of biochemical and/or radiological disease progression in the setting of surgical or medical castration. Patients must have received prior hormonal treatment with at least one of abiraterone acetate, enzalutamide, ARN-509 TAK-700 and TOK-001. Prior anti-androgen therapy must have been discontinued >=28 days (>=42 days for bicalutamide) prior to registration. Maximum of one prior regimen of cytotoxic chemotherapy permitted. Prior immunotherapy, vaccines and oncolytic viruses permitted. Prior/concurrent CDK or mTOR inhibitors, strontium-89, systemic corticosteriods equivalent to prednisone >10 mg daily not allowed. Potent/strong CYP3A inhibitors/inducers not allowed.

    Objectives: PRIMARY - To assess the clinical benefit rate (CBR) of palbociclib in patients with metastatic, castration-resistant prostate cancer (mCRPC). SECONDARY - (1) To determine the effect of palbociclib on PSA decline and time to PSA progression; (2) To determine objective response as determined by RECIST 1.1 criteria; (3) To evaluate the safety and toxicity profile of palbociclib in mCRPC patients. EXPLORATORY - (1) To determine whether CCND1 gain/amplification in plasma cell-free DNA (cfDNA) (+/-RB1 wild type) is predictive of CBR to palbociclib; (2) To evaluate gene copy number variation and mutation profile of cfDNA in patients with mCRPC before and after treatment with palbociclib; (3) To identify potential predictive and prognostic blood-based RNA markers.

    NCT Registration ID (from clinicaltrials.gov): NCT02905318
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Closed to Accrual
    Activation Date: February 09, 2017 Closing Date: December 13, 2021



    		Closed to Accrual
    I234B

    A Phase II Study of Savolitinib, A CMET Inhibitor, in Patients with Metastatic Castration-Resistant Prostate Cancer - A Sub-Study of IND.234


    A Phase II Study of Savolitinib, A CMET Inhibitor, in Patients with Metastatic Castration-Resistant Prostate Cancer - A Sub-Study of IND.234

    Complexity Level: 1

    Eligibility: Patients must meet the following criteria in addition to the eligibility criteria outlined in IND.234.Men of childbearing potential must have agreed to use a highly effective contraceptive method during Study Drug treatment and for 6 months after stopping treatment and should not father a child or donate sperm during this period. Patients with significantly abnormal liver diseases including viral/other hepatitis, current alcohol abuse or cirrhosis are not eligible. Patients in whom strong inducers or inhibitors of CYP3A4 and strong inhibitors of CYP1A2 cannot be discontinued within 2 weeks before the first dose of savolitinib (3 weeks for St John's Wort) are not eligible..

    Objectives: To determine the effect of savolitinib on PSA decline and time to PSA progression. To determine objective response as determined by RECIST 1.1 criteria. To evaluate the safety and toxicity profile of savolitinib in mCRPC patients. Tertiary Objectives To obtain cfDNA and non-malignant DNA from peripheral blood clinically annotated with patient disease characteristics and follow-up data to identify potential predictive and prognostic factors and relationship between cfDNA results with clinical presentation.

    NCT Registration ID (from clinicaltrials.gov): NCT03385655
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: CCTG Led Trial
    Status: Closed to Accrual
    Activation Date: December 12, 2017 Closing Date: February 27, 2024



    		Closed to Accrual
    I234A

    A Phase II Study of AZD1775, A WEE1 Inhibitor, in Patients with Metastatic Castration-Resistant Prostate Cancer - A Sub-Study of IND.234


    A Phase II Study of AZD1775, A WEE1 Inhibitor, in Patients with Metastatic Castration-Resistant Prostate Cancer - A Sub-Study of IND.234

    Complexity Level: 1

    Eligibility: Patients must meet the following criteria in addition to the eligiblity criteria outlined in IND.234. Patients without history of hypersensitivity to AZD1775 or any of its excipients or who have not received treatment with drugs with a similar mechanism of action. Patients witout any factors that increase the risk of QTc prolongation or risk of arrhythmic events or mean resting corrected QT interval (QTc) <= 470 msec. Patients on drugs with a narrow therapeutic index which are substrates of BRCP, PGP, CYP2C19 or CYP1A2, inhibitors of PGP, and which cannot be discontinued or changed to alternative drugs are not eligible.

    Objectives: To determine the effect of AZD1775 on PSA decline and time to PSA progression. To determine objective response as determined by RECIST 1.1 criteria. To evaluate the safety and toxicity profile of AZD1775 in mCRPC patients. Tertiary Objectives To obtain cfDNA and non-malignant DNA from peripheral blood clinically annotated with patient disease characteristics and follow-up data to identify potential predictive and prognostic factors and relationship between cfDNA results with clinical presentation.

    NCT Registration ID (from clinicaltrials.gov): NCT03385655
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: CCTG Led Trial
    Status: Closed to Accrual
    Activation Date: December 12, 2017 Closing Date: December 08, 2021



    		Closed to Accrual
    I234

    Prostate Cancer Biomarker Enrichment and Treatment Selection (PC_BETS) Study - Master Screening Protocol


    Prostate Cancer Biomarker Enrichment and Treatment Selection (PC_BETS) Study - Master Screening Protocol

    Complexity Level: 1

    Eligibility: Patients (>=18 years old, ECOG PS 0-1) must have histologically confirmed mCRPC with no evidence of small cell/neuroendocrine differentiation. Patients must consent to undergo genomic screening. Clinically/radiologically documented disease (measurable or non-measurable). Evidence of biochemical and/or radiological disease progression in the setting of surgical or medical castration. Patients must have received prior hormonal treatment with at least one of abiraterone acetate, enzalutamide, ARN-509 TAK-700 and TOK-001. Prior anti-androgen therapy must have been discontinued >=28 days (>=42 days for bicalutamide) prior to registration. Maximum of one prior regimen of cytotoxic chemotherapy permitted. Prior immunotherapy, vaccines and oncolytic viruses permitted. Prior/concurrent CDK or mTOR inhibitors, strontium-89, systemic corticosteriods equivalent to prednisone >10 mg daily not allowed.

    Objectives: Primary Objective - To centrally genotype cfDNA from patients with mCRPC progressing after a "next-generation" AR-pathway inhibitor in order to facilitate accrual to targeted therapy trials and then to assess the clinical benefit rate (CBR), of each Study Drug. Secondary Objectives - To determine the effect of each Study Drug on PSA decline and time to PSA progression. To determine objective response as determined by RECIST 1.1 criteria. To evaluate the safety and toxicity profile of each Study Drug in mCRPC patients. Tertiary Objectives - To obtain cfDNA and non-malignant DNA from peripheral blood clinically annotated with patient disease characteristics and follow-up data to identify potential predictive and prognostic factors and relationship between cfDNA results with clinical presentation.

    NCT Registration ID (from clinicaltrials.gov): NCT03385655
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Closed to Accrual
    Activation Date: December 12, 2017 Closing Date: February 27, 2024



    		Closed to Accrual
    I232

    A Phase II Study of Durvalumab (MEDI4736) With or Without Tremelimumab in Patients With Metastatic Castration Resistant Prostate Cancer


    A Phase II Study of Durvalumab (MEDI4736) With or Without Tremelimumab in Patients With Metastatic Castration Resistant Prostate Cancer

    Complexity Level: 2

    Eligibility: Patients with histologically confirmed adenocarcinoma of the prostate that is castrate resistant. Must have disease progression either PSA, objective or both as well as surgical or medical castration with testosterone levels <50mg/dL. An available tissue block from primary or metastatic tumour as well as accessible disease suitable for fresh biopsy and consent to biopsy prior to treatment is required. Patients must have measurable disease per RECIST 1.1. Patients may have received prior treatment with docetaxel chemotherapy, tyrosine kinase or other targeted agents. Failure/progression on abiraterone and/or enzalutamide is required. Antiandrogens must have been discontinued for < 4 weeks prior to study entry (6 weeks for bicalutamide). No prior immunotherapy or vaccines, treatment with oncolytics viruses is permissible. No prior history of immunodeficiency, or use or immunosuppressive agents within 28 days of randomization.

    Objectives: Primary - To determine the objective response rate (RECIST 1.1 and irRECIST) in patients with metastatic castration resistant prostate cancer (mCRPC) treated with durvalumab alone or in combination with tremelimumab. Secondary - To determine the prostate-specific antigen (PSA) response rate as time to PSA progression; To evaluate time to objective disease progression; To evaluate the toxicity and tolerability of durvalumab alone or in combination with tremelimumab. Exploratory - To explore the utility of tissue and blood based biomarkers to select patients for treatment with durvalumab alone or in combination with tremelimumab.

    NCT Registration ID (from clinicaltrials.gov): NCT02788773
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Closed to Accrual
    Activation Date: August 18, 2016 Closing Date: October 01, 2019



    		Closed to Accrual
    I234C

    A Phase II Study of Darolutamide (ODM-201) in Patients with Metastatic Castration-Resistant Prostate Cancer Previously Treated with Abiraterone Acetate or Enzalutamide - A Sub-Study of IND.234


    A Phase II Study of Darolutamide (ODM-201) in Patients with Metastatic Castration-Resistant Prostate Cancer Previously Treated with Abiraterone Acetate or Enzalutamide - A Sub-Study of IND.234

    Complexity Level: 1

    Eligibility: Patients must meet the following criteria in addition to the eligiblity criteria outlined in IND.234. Serum potassium within normal limits. Prior abiraterone acetate or enzalutamide but not both. No prior cytotoxic systemic chemotherapy in the CRPC setting.

    Objectives: To determine the effect of darolutamide on PSA decline and time to PSA progression. To determine objective response as determined by RECIST 1.1 criteria. To evaluate the safety and toxicity profile of darolutamide in mCRPC patients. Tertiary Objectives To obtain cfDNA and non-malignant DNA from peripheral blood clinically annotated with patient disease characteristics and follow-up data to identify potential predictive and prognostic factors and relationship between cfDNA results with clinical presentation.

    NCT Registration ID (from clinicaltrials.gov): NCT03385655
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: CCTG Led Trial
    Status: Closed to Accrual
    Activation Date: December 12, 2017 Closing Date: February 27, 2024



    		Closed to Accrual
    I195

    A Phase II Study of SB939 in Patients with Recurrent or Metastatic Castration Resistant Prostate Cancer


    A Phase II Study of SB939 in Patients with Recurrent or Metastatic Castration Resistant Prostate Cancer

    Complexity Level: 2

    Eligibility: Patients with a histological diagnosis of metastatic and/or locally recurrent castration resistant adenocarcinoma of the prostate. Patients must be hormone refractory and have discontinued anti-androgens for at least 4 weeks prior to study entry. PSA >= 5 ng/mL at study entry. Up to 1 prior chemotherapy regimen is permitted. ECOG 0 or 1. Adequate cardiac function and acceptable end-organ function.

    Objectives: 1.1 The primary objective of this study is to determine the efficacy (as measured by PSA response and progression free survival) of SB939 when given orally every other day 3 times a week, in patients with castration resistant prostate cancer, who have received 0-1 prior chemotherapy regimens. 1.2 To determine objective response and response duration in patients with measurable disease at baseline. 1.3 To determine the tolerability and toxicity of SB939 in this population. 1.4 Enumeration of Circulating Tumour Cells (CTC) at baseline and after 6 weeks (and 12 weeks if patient is still on study treatment) using two methodologies. 1.5 To explore potential molecular factors predictive of response by assessment of archival prostate tumour tissue. 1.6 To explore the utility of ERG and PTEN expression on circulating tumour cells as a potential prognostic and predictive marker for response to SB939. 1.7 To describe time to PSA and time to objective progression in patients treated with SB939.

    NCT Registration ID (from clinicaltrials.gov): NCT01075308
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: February 10, 2010 Closing Date: November 04, 2011



    		Permanently Closed
    I111

    A Randomized Phase II Study of CGP 64128A (ISIS 3521) and CGP 69846A (ISIS 5132) in Hormone Refractory Prostate Cancer


    A Randomized Phase II Study of CGP 64128A (ISIS 3521) and CGP 69846A (ISIS 5132) in Hormone Refractory Prostate Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: February 12, 1998 Closing Date: January 22, 1999



    		Permanently Closed
    I49

    NCIC CTG Phase II Study of Gemcitabine in Renal Cell Carcinoma


    NCIC CTG Phase II Study of Gemcitabine in Renal Cell Carcinoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: March 19, 1990 Closing Date: November 30, 1990



    		Permanently Closed
    I143

    A Phase II Study Of MG98 Given as a 2-Hour Twice Weekly Infusion in Patients With Advanced and/or Metastatic Renal Cell Carcinoma


    A Phase II Study Of MG98 Given as a 2-Hour Twice Weekly Infusion in Patients With Advanced and/or Metastatic Renal Cell Carcinoma

    Eligibility: Patients with recurrent or metastatic renal cell carcinoma. No prior chemotherapy or immunotherapy for advanced/recurrent disease. Clinically and/or radiologically documented unidimensionally measurable disease.

    Objectives: To evaluate the efficacy and safety of MG98 when given as a 2-hour IV infusion twice weekly for 3 out or every 4 weeks in patients with advanced and/or metastatic renal cell carcinoma.

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: May 01, 2001 Closing Date: May 10, 2002



    		Permanently Closed
    I4

    NCIC CTG Phase II Study of Lonidamine in Hypernephroma


    NCIC CTG Phase II Study of Lonidamine in Hypernephroma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 01, 1982 Closing Date: May 05, 1984



    		Permanently Closed
    I209

    A Randomized Phase II Study of Reolysin in Combination With Docetaxel and Prednisone or Docetaxel and Prednisone Alone in Patients With Metastatic Castration Resistant Prostate Cancer


    A Randomized Phase II Study of Reolysin in Combination With Docetaxel and Prednisone or Docetaxel and Prednisone Alone in Patients With Metastatic Castration Resistant Prostate Cancer

    Complexity Level: 2

    Eligibility: Patients with a histological diagnosis of metastatic and/or locally recurrent castration resistant adenocarcinoma of the prostate. Tumour block available. Patients must be hormone refractory and have discontinued anti-androgens for at least 4 weeks prior to study entry. PSA >= 5 ng/mL at study entry. No prior chemotherapy for recurrent/metastatic disease. No prior docetaxel unless given adjuvantly and >= 12 months prior to enrollment. ECOG 0, 1 or 2. Adequate end-organ function.

    Objectives: 1. To evaluate efficacy which will be based on the lack of disease progression measured at 12 weeks. 2a. To determine the tolerability and toxicity of Reolysin and docetaxel when given in combination. 2b. To investigate additional potential measures of efficacy including CTC status, CTC conversion rate, change in PSA levels, Objective response rate and effect of both treatments on overall survival. 2c. Explore potential molecular factors predictive of response in archival tumour and baseline CTCs.

    NCT Registration ID (from clinicaltrials.gov): NCT01619813
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 11, 2012 Closing Date: September 25, 2015



    		Permanently Closed
    I46

    NCIC CTG Phase II Study of LY186641 in Patients With Renal Cell Carcinoma


    NCIC CTG Phase II Study of LY186641 in Patients With Renal Cell Carcinoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: October 25, 1989 Closing Date: May 11, 1990



    		Permanently Closed
    I205

    A Phase II Study of PX-866 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer (CRPC).


    A Phase II Study of PX-866 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer (CRPC).

    Complexity Level: 2

    Eligibility: Androgen ablation must include either medical or surgical castration. If the patient is receiving medical androgen ablation, a castrate level of testosterone (< 1.7 nmol/L) must be present. Patients must have metastatic or locally recurrent disease, for which no curative therapy exists and for which systemic therapy is indicated due to progression following castration. Either:PSA Progression: A rising PSA, while receiving androgen ablative therapy, with 2 subsequent rises over a reference value (not necessarily consecutively), measured a minimum of one week apart. The PSA that confirms progression must have a value of >= 5 ng/ml and must be performed no longer than 7 days prior to trial registration.OR Radiological Progression. The PSA must be >=5 ng/ml at the time of study entry. ECOG performance of 0, 1 or 2; Age > 18 years of age. All patients must have formalin fixed paraffin embedded tissue. Presence of clinically and/or radiologically documented disease.

    Objectives: To determine the efficacy of PX-866 when given orally daily in patients with castration resistant prostate cancer, who have received no prior chemotherapy regimens for recurrent disease.To determine the tolerability and toxicity. of PX-866 in this population. To investigate additional potential measures of efficacy including: PSA response rate, Objective response rate, Change in circulating tumour cell number during treatment. To explore potential molecular factors predictive of response by assessment of archival prostate tumour tissue and baseline circulating tumour cells. In selected participating centres, to determine evidence of effect on PI3K activation pre- and post administration of PX-866 in platelets

    NCT Registration ID (from clinicaltrials.gov): NCT01331083
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 04, 2011 Closing Date: January 10, 2014



    		Permanently Closed
    I167

    Phase II Study of BAY 43-9006 (NSC 724772) in Patients With Hormone Refractory Prostate Cancer


    Phase II Study of BAY 43-9006 (NSC 724772) in Patients With Hormone Refractory Prostate Cancer

    Eligibility: Patients with histologically or cytologically diagnosed prostate cancer that is advanced and non-curable with standard therapy. PSA progression with PSA>10 ng/mL at study entry. Primary tumour available for immunohistochemistry. No prior chemotherapy. Minimally symptomatic disease.

    Objectives: To determine PSA response rate. To determine objective response rate and duration of response as measured by RECIST. To determine the tolerability and toxicity of BAY 43-9006 given to this patient population. To describe time to treatment failure and overall patient survival. To correlate the relationship between tumour markers and patients with response and with non-progression.

    NCT Registration ID (from clinicaltrials.gov): NCT00093457
    Participation: Limited to invited centres only.
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 21, 2004 Closing Date: December 20, 2005



    		Permanently Closed
    I165

    A Randomized Phase II Study Of OGX-011 In Combination With Docetaxel And Prednisone Or Docetaxel And Prednisone Alone In Patients With Metastatic Hormone Refractory Prostate Cancer.


    A Randomized Phase II Study Of OGX-011 In Combination With Docetaxel And Prednisone Or Docetaxel And Prednisone Alone In Patients With Metastatic Hormone Refractory Prostate Cancer.

    Eligibility: Histologically or cytologically diagnosed prostate cancer with documented evidence of progression by rising PSA (>5 ng/mL at baseline). Patients must have metastatic or locally recurrent disease for which no curative therapy exists and for which systemic chemotherapy is indicated due to progression while receiving androgen ablative therapy. No prior chemotherapy except estramustine. Prior hormone therapy permitted but must be refractory and discontinued > 4 weeks (6 wks for bicalutamide). Prior radiation permitted if > 4 weeks. ECOG 0, 1, 2. Adequate organ function. No pre-existing neuropathy >= grade 2 or therapeutic anti-coagulation.

    Objectives: To determine the efficacy, as measured by PSA response and duration of response, of weekly OGX-011 administered intravenously in combination with q 3 weekly docetaxel and prednisone, or docetaxel and prednisone in patients with HRPC. To determine objective response and duration in those with measurable disease at baseline. To determine tolerability and toxicity when given in this schedule. To measure evidence of OGX-011 and docetaxel or docetaxel effect on serum clusterin levels. To describe time to progression and overall patient survival for both cohorts.

    NCT Registration ID (from clinicaltrials.gov): NCT00258388
    Participation: Limited to selected centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 27, 2005 Closing Date: December 21, 2006



    		Permanently Closed
    I161

    A Phase II Study of Triapine (NSC 663249) in Previously Untreated Patients With Recurrent Renal Cell Carcinoma


    A Phase II Study of Triapine (NSC 663249) in Previously Untreated Patients With Recurrent Renal Cell Carcinoma

    Eligibility: Patients with histologically or cytologically documented renal cell cancer that is locally recurrent or metastatic. Clinically and/or radiologically documented disease. Unidimensionally measurable disease. No prior systemic chemotherapy regimens. Previous interferon permitted > 3 months prior to study entry. No immunotherapy for advanced/recurrent disease. No gene therapy. Known HIV-positive patients are not permitted nor patients with known glucose-6 phosphate dehydrogenase deficiency.

    Objectives: To assess the efficacy (objective response rate) of Triapine given as a 2-hour IV infusion for 4 consecutive days every other week to patients with recurrent/ metastatic renal cell cancer who have received no prior systemic therapy for recurrence. To determine adverse events and tolerability of Triapine in this patient population. To describe time to disease progression and overall patient survival.

    NCT Registration ID (from clinicaltrials.gov): NCT00075660
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 16, 2004 Closing Date: April 05, 2005



    		Permanently Closed
    I153

    A Phase I Study of Combination Neoadjuvant Hormone Therapy and Weekly OGX-011 (Clusterin Antisense Oligonucleotide) Prior to Radical Prostatectomy in Patients With Localized Prostate Cancer


    A Phase I Study of Combination Neoadjuvant Hormone Therapy and Weekly OGX-011 (Clusterin Antisense Oligonucleotide) Prior to Radical Prostatectomy in Patients With Localized Prostate Cancer

    Eligibility: Histologically confirmed adenocarcinoma of the prostate. No prior treatment. Must be a potential candidate for radical prostatectomy. Minimum 2 positive biopsies and at least one of the following: clinical stage T3; serum PSA > 10 ng/ml; Gleason score 7-10 or Gleason score 6 and >= 3 positive biopsies

    Objectives: To determine the toxicity and define the recommended phase II dose of OGX-011 administered days 1, 3, 5, 8, 15, 22 and 29 intravenously with neoadjuvant hormone therapy prior to radical prostatectomy. To determine the plasma pharmacokinetic profile To determine the tissue concentration of OGX-011 in radical prostatectomy specimens. To measure evidence of effect on clusterin expression in peripheral blood mononuclear cells and clusterin serum levels. To assess the effect of the combined hormone and OGX-011 therapy on com[plete response rates. To attempt to establish correlations between palsma and or prostate concentrations of OGX-011 with patient response or toxicity.

    NCT Registration ID (from clinicaltrials.gov): NCT00054106
    Participation: Limited to one centre: BCCA-Vancouver
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: December 06, 2002 Closing Date: May 05, 2004



    		Permanently Closed
    I6

    NCIC CTG Phase II Study of Interferon in Renal Cell Cancer


    NCIC CTG Phase II Study of Interferon in Renal Cell Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: November 01, 1983 Closing Date: September 20, 1984



    		Permanently Closed
    I70

    NCIC CTG Phase II Study of Taxotere in Patients With Metastatic Renal Cell Carcinoma


    NCIC CTG Phase II Study of Taxotere in Patients With Metastatic Renal Cell Carcinoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 24, 1992 Closing Date: February 03, 1993



    		Permanently Closed
    I95

    NCIC CTG Phase II Study of Gemcitabine/Cisplatin in Patients With Inoperable, Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelial Tract


    NCIC CTG Phase II Study of Gemcitabine/Cisplatin in Patients With Inoperable, Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelial Tract

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 06, 1996 Closing Date: October 03, 1997



    		Permanently Closed
    I88

    A Phase I/II Study of 9-Cis-Retinoic Acid (LGD1057) and Interferon a-2b (INTRON A) in Patients With Recurrent or Metastatic Renal Cell Carcinoma


    A Phase I/II Study of 9-Cis-Retinoic Acid (LGD1057) and Interferon a-2b (INTRON A) in Patients With Recurrent or Metastatic Renal Cell Carcinoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 03, 1995 Closing Date: April 29, 1997



    		Permanently Closed
    I24

    NCIC CTG Phase II Study of Deoxycoformycin in Renal Cell


    NCIC CTG Phase II Study of Deoxycoformycin in Renal Cell

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: September 06, 1985 Closing Date: November 26, 1986



    		Permanently Closed
    I38

    NCIC CTG Phase II Study of TNF in Renal Cell


    NCIC CTG Phase II Study of TNF in Renal Cell

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 01, 1988 Closing Date: September 01, 1989



    		Permanently Closed
    I140

    A Randomized Phase II Study Of ZD1839 (Iressa) in Patients With Hormone Refractory Prostate Cancer


    A Randomized Phase II Study Of ZD1839 (Iressa) in Patients With Hormone Refractory Prostate Cancer

    Eligibility: Prostate cancer patients with evidence of progression by rising PSA or progressive measurable disease on androgen ablative therapy; PSA > 20 ng/mL; chemo-naive; minimally symptomatic disease.

    Objectives: To determine the efficacy, and toxicity of two different doses of ZD1839 (250 mg or 500 mg) in patients with hormone refractory prostate cancer. Objective response where applicable, PSA response and duration of these responses, will be measured.

    NCT Registration ID (from clinicaltrials.gov): NCT00025116
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 24, 2001 Closing Date: April 25, 2002



    		Permanently Closed
    I119

    A Phase II Study of Troxacitabine in Patients With Advanced and/or Metastatic Renal Cell Carcinoma


    A Phase II Study of Troxacitabine in Patients With Advanced and/or Metastatic Renal Cell Carcinoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 16, 1999 Closing Date: March 21, 2000



    		Permanently Closed
    I128

    NCIC CTG Phase II Study of SCH66336 in Patients With Inoperable, Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelial Tract Who Have Received Prior Chemotherapy


    NCIC CTG Phase II Study of SCH66336 in Patients With Inoperable, Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelial Tract Who Have Received Prior Chemotherapy

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: December 03, 1999 Closing Date: May 01, 2001



    		Permanently Closed
    I240C

    A PHASE II STUDY OF TORIPALIMAB-TPZI (LOQTORZI ®) AND ENB-003, AN ENDOTHELIN B RECEPTOR (ETBR) INHIBITOR IN PATIENTS WITH PLATINUM RESISTANT OR REFRACTORY HIGH GRADE SEROUS OVARIAN CANCER OR CLEAR CELL OVARIAN CARCINOMA


    A PHASE II STUDY OF TORIPALIMAB-TPZI (LOQTORZI ®) AND ENB-003, AN ENDOTHELIN B RECEPTOR (ETBR) INHIBITOR IN PATIENTS WITH PLATINUM RESISTANT OR REFRACTORY HIGH GRADE SEROUS OVARIAN CANCER OR CLEAR CELL OVARIAN CARCINOMA

    Complexity Level: 1

    Eligibility: Patients must have platinum resistant or platinum refractory high grade serous or clear cell carcinoma of ovarian, fallopian tube or peritoneal origin. Platinum resistant disease defined as progression within 6 months of last platinum containing chemotherapy. Platinum refractory disease defined as progression during the administration of the first or second line of platinum containing chemotherapy. Histological confirmation of the original primary tumour. No limit to the number of prior regimens for platinum sensitive disease. But, patients may not have received more than one cytotoxic chemotherapy regimen for platinum resistant or refractory disease. If applicable, the use effective contraception defined as post-menopausal, surgically sterile (hysterectomy or ovariectomy) or on two forms of birth control while on study and 6 months after last treatment. of ENB-003 and toripalimab.

    Objectives: For complete list of objectives please refer to the main protocol. For this substudy imRECIST will be explored as a secondary objective.

    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: CCTG Led Trial
    Status: Planned



    		Planned
    I240

    An Immunotherapy Platform Study in Platinum Resistant High Grade Serous Ovarian Cancer (IPROC)

    The purpose of the pre-study screening is to test for biomarkers. This testing will be done on a sample of tissue removed from a previous surgery or biopsy. If a previous tissue sample is not available, a fresh tissue biopsy is required. Each substudy will be looking at what effects a new drug or drugs has on patients and their ovarian cancer and as well as side effects of treatment. The purpose of each substudy is to see if the biomarkers that were identified the screening sample can help predict which patients are most likely to be helped by that drug or drugs and to see how the cancer cells respond to treatment.

    An Immunotherapy Platform Study in Platinum Resistant High Grade Serous Ovarian Cancer (IPROC)

    Complexity Level: 1

    Eligibility: Patients (>=18 yrs old, ECOG PS 0-1), life expectancy >= 3 mo., must have platinum resistant high-grade serous carcinoma of ovarian, fallopian tube or peritoneal origin defined as progression within the last 6 mo. of last platinum containing chemo. Histological confirmation of original primary tumour. Measurable disease per RECIST 1.1. No limit on prior regimens for platinum sensitive disease but may not have received more than 1 cytotoxic chemotherapy regimen for platinum-resistant disease. Prior treatment with immune checkpoint inhibitors is allowed provided it was not discontinued due to severe/recurrent severe toxicity. May have received non-cytotoxic therapies excluding the agents targeted by the planned substudy. Consent to pre/on treatment tumour biopsies. No uncontrolled/serious illnesses or medical conditions which would not permit the patient to be managed per protocol. No central nervous system metastases. No prior autoimmune or inflammatory disorders within the past 3 yrs.

    Objectives: Primary: identify based on objective response rate (ORR) (complete and partial response) using RECIST 1.1, promising immunotherapy combinations for the treatment of high grade serious ovarian cancer for later validation in clinical trials. Secondary: evaluate ORR using iRECIST, determine progression free survival and overall survival of immunotherapy regimens (RECIST 1.1 and iRECIST), examine safety and tolerability of each regimen. Tertiary: explore utility of CA125 as a surrogate of response in patients receiving immunotherapies, identify potential predictive biomarkers/markers of response, generate biomarker and clinical data to identify new immunotherapy strategies/combinations for subsequent evaluation.

    NCT Registration ID (from clinicaltrials.gov): NCT04918186
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Open to Accrual
    Activation Date: October 12, 2021



    		Open to Accrual
    I240B

    A Phase II Study of Durvalumab and BA3021, A CAB-ROR2-ADC in Patients with Platinum Resistant High Grade Serous Ovarian Cancer

    The purpose of this study is to test the safety of the new drugs, durvalumab and BA3021, to see what effects they have on you and your cancer. This study will also look at the side effects of these two drugs. The researchers are also looking for ways to help predict who is most likely to be helped by these drugs by testing for other gene changes in tumour and blood samples.

    A Phase II Study of Durvalumab and BA3021, A CAB-ROR2-ADC in Patients with Platinum Resistant High Grade Serous Ovarian Cancer

    Complexity Level: 1

    Eligibility: Females of childbearing/reproductive potential must agree to use effective contraception while on the study and for 6 months after last dose of BA3021. ROR2-postive tumour in Stage 2. No prior therapy with agents targeting ROR2, or with a conjugated or unconjugated auristatin derivative / vinca targeting payload. No prior receipt of G-CSF or granulocyte/macrophage colony stimulating factor support 2 week prior to first BA3021 dose. No history of ? 3 Grade allergic reactions to monoclonal antibody therapy or known/suspected allergy/ intolerance to any agent given during study. No serious medical conditions i.e; intracerebral arteriovenous malformation, cerebral aneurysm or stroke, history of hepatic encephalopathy; clinically significant ascites, as measured by physical examination; active drug or alcohol abuse. No use of moderate or strong CYP3A inducers or inhibitors, including cannabidiol P-glycoprotein (P-gp) inhibitors or immunosupressants.

    Objectives: See main protocol

    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: CCTG Led Trial
    Status: Open to Accrual
    Activation Date: October 12, 2021



    		Open to Accrual
    I240A

    A Phase II Study of Durvalumab and BA3011, A CAB-AXL-ADCin Patients with Platinum Resistant High Grade Serous Ovarian Cancer

    The purpose of this study is to test the safety of the new drugs, durvalumab and BA3011, to see what effects they have on you and your cancer. This study will also look at the side effects of these two drugs. The researchers are also looking for ways to help predict who is most likely to be helped by these drugs by testing for other gene changes in tumour and blood samples.

    A Phase II Study of Durvalumab and BA3011, A CAB-AXL-ADCin Patients with Platinum Resistant High Grade Serous Ovarian Cancer

    Complexity Level: 1

    Eligibility: Females of childbearing/reproductive potential must agree to use effective contraception on study and 6 months after last dose of BA3011. AXL-positive tumour in Stage 1. No prior therapy with agents targeting AXL or with a conjugated or unconjugated auristatin derivative / vinca targeting payload. No prior receipt of G-CSF or granulocyte/macrophage colony stimulating factor support 2 week prior to first BA3011 dose. No history of greater than or equal to 3 Grade allergic reactions to monoclonal antibody therapy or known/suspected allergy/ intolerance to any agent given during study. No serious medical conditions i.e; intracerebral arteriovenous malformation, cerebral aneurysm or stroke, history of hepatic encephalopathy; clinically significant ascites, measured by physical examination; active drug or alcohol abuse. Patients must not be using moderate or strong CYP3A inducers or inhibitors, including cannabidiol P-glycoprotein (P-gp) inhibitors or immunosupressants.

    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: CCTG Led Trial
    Status: Open to Accrual
    Activation Date: October 12, 2021



    		Open to Accrual
    I106B

    Phase II Study of Topotecan/Cisplatin Followed by Paclitaxel/Carboplatin as First-Line Chemotherapy for Patients With Advanced Ovarian Cancer


    Phase II Study of Topotecan/Cisplatin Followed by Paclitaxel/Carboplatin as First-Line Chemotherapy for Patients With Advanced Ovarian Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 27, 1999 Closing Date: December 16, 1999



    		Permanently Closed
    I74

    NCIC CTG Phase I Study of Biweekly Taxol/Cisplatin as Initial Chemotherapy for Ovarian Cancer


    NCIC CTG Phase I Study of Biweekly Taxol/Cisplatin as Initial Chemotherapy for Ovarian Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: November 02, 1992 Closing Date: October 07, 1994



    		Permanently Closed
    I116

    NCIC CTG Phase II Study of CGP 69846A (ISIS 5132) in Recurrent Epithelial Ovarian Cancer


    NCIC CTG Phase II Study of CGP 69846A (ISIS 5132) in Recurrent Epithelial Ovarian Cancer

    NCT Registration ID (from clinicaltrials.gov): NCT00003892
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: February 01, 1999 Closing Date: May 05, 2000



    		Permanently Closed
    I51

    NCIC CTG Phase I Study of GM-CSF + Carboplatin/Cyclophosphamide in Ovary


    NCIC CTG Phase I Study of GM-CSF + Carboplatin/Cyclophosphamide in Ovary

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: May 29, 1989 Closing Date: February 10, 1990



    		Permanently Closed
    I12

    NCIC CTG Phase II Study of CBDCA in Ovary


    NCIC CTG Phase II Study of CBDCA in Ovary

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 01, 1984 Closing Date: February 21, 1985



    		Permanently Closed
    I160

    A Phase II Study Of CCI-779 In Patients With Metastatic and/or Locally Advanced Recurrent Endometrial Cancer


    A Phase II Study Of CCI-779 In Patients With Metastatic and/or Locally Advanced Recurrent Endometrial Cancer

    Complexity Level: 2

    Eligibility: Patients with histologically documented endometrial cancer. Clinically and/or radiologically documented disease. Unidimensionally measurable disease. Tumour tissue available from primary tumour to assess molecular markers of CCI-779 activation. Group A patients may have had up to one prior hormonal treatment (adjuvant or metastatic) with no prior chemotherapy permitted. Group B patients may have had an unlimited number of prior hormonal treatments (adjuvant or metastatic) and must have had one cycle of cytotoxic chemotherapy.

    Objectives: To assess the efficacy (response rate and duration of stable disease) of CCI-779 given IV weekly in patients with metastatic and/or locally advanced recurrent carcinoma of the endometrium. To assess the adverse events, time to progression and response duration of CCI-779 given IV weekly in patients with metastatic and/or locally advanced recurrent carcinoma of the endometrium. To correlate objective tumour response with PTEN expression in the tumour tissue obtained at diagnosis (primary tumour). To explore the relatinoship between objective tumour response with other molecular measures in diagnostic tumour tissue.

    NCT Registration ID (from clinicaltrials.gov): NCT00072176
    Participation: Limited to invited centres only.
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 14, 2004 Closing Date: June 15, 2007



    		Permanently Closed
    I82

    NCIC CTG Randomized Phase II Study of Topotecan in Previously Treated Patients With Ovarian Cancer


    NCIC CTG Randomized Phase II Study of Topotecan in Previously Treated Patients With Ovarian Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 08, 1994 Closing Date: April 22, 1997



    		Permanently Closed
    I59

    NCIC CTG Phase I Study of IL-3 in Patients With Relapsed Ovarian Cancer Receiving Carboplatin


    NCIC CTG Phase I Study of IL-3 in Patients With Relapsed Ovarian Cancer Receiving Carboplatin

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: December 10, 1990 Closing Date: March 27, 1992



    		Permanently Closed
    I199

    A Phase II Study of Temsirolimus (NSC 683864), an mTOR Inhibitor, in Patients with Recurrent, Unresectable, Locally Advanced or Metastatic Carcinoma of the Cervix.


    A Phase II Study of Temsirolimus (NSC 683864), an mTOR Inhibitor, in Patients with Recurrent, Unresectable, Locally Advanced or Metastatic Carcinoma of the Cervix.

    Complexity Level: 2

    Eligibility: Patients with histologically or cytologically confirmed squamous cell carcinoma or adenosquamous carcinoma of the cervix, or adenocarcinoma of the cervix. Clinically and/or radiologically documented disease. Only one prior chemotherapy regimen allowed. Patient must be > 4 weeks since chemotherapy, radiation therapy and surgery. No prior treatment with an mTOR inhibitor. Patient must have tumour tissue from their primary tumour available.

    Objectives: 1.1 To assess the efficacy (objective response rate) of temsirolimus given IV weekly in patients with metastatic and/or locally advanced recurrent carcinoma of the cervix. 1.2 To assess the adverse events, time to progression and response duration of temsirolimus given IV weekly in patients with metastatic and/or locally advanced recurrent carcinoma of the cervix. 1.3 To explore the relationship between expression of proteins in the mTOR pathway in archival tissue samples from patients on this trial and their objective response to therapy.

    NCT Registration ID (from clinicaltrials.gov): NCT01026792
    Participation: Limited to invited centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: December 17, 2009 Closing Date: October 27, 2011



    		Permanently Closed
    I51A

    NCIC CTG Phase I Study of GM-CSF Plus Carboplatin in Ovary


    NCIC CTG Phase I Study of GM-CSF Plus Carboplatin in Ovary

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: February 10, 1990 Closing Date: September 28, 1990



    		Permanently Closed
    I138

    NCIC CTG Randomized Phase II Study of NX211 Given by Two Different Intravenous Schedules in Advanced and/or Recurrent Epithelial Ovarian Cancer


    NCIC CTG Randomized Phase II Study of NX211 Given by Two Different Intravenous Schedules in Advanced and/or Recurrent Epithelial Ovarian Cancer

    Eligibility: Histologically documented advanced and/or recurrent epithelial ovarian cancer (primary fallopian or peritoneal cancer also eligible). One or two prior regimens of chemotherapy required with at least one regimen containing cisplatin or carboplatin. At least one site unidimensional disease.

    Objectives: To evaluate, in parallel, the efficacy of two treatment schedules of NX211 as determined by objective response and tumour marker (CA125) in patients with advanced and/or recurrent ovarian cancer. To evaluate the safety, time to progression, and pharmacokinetics of both treatment schedules.

    NCT Registration ID (from clinicaltrials.gov): NCT00010179
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: October 31, 2000 Closing Date: September 21, 2001



    		Permanently Closed
    I106

    NCIC CTG Phase II Study of Topotecan/Cisplatin/Paclitaxel as First-Line Chemotherapy for Patients With Advanced Ovarian Cancer


    NCIC CTG Phase II Study of Topotecan/Cisplatin/Paclitaxel as First-Line Chemotherapy for Patients With Advanced Ovarian Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 10, 1997 Closing Date: May 07, 1998



    		Permanently Closed
    I185

    A Phase II Study Of Sunitinib (SU11248; NSC 736511) In Patients With Recurrent Epithelial Ovarian, Fallopian Tube Or Primary Peritoneal Carcinoma


    A Phase II Study Of Sunitinib (SU11248; NSC 736511) In Patients With Recurrent Epithelial Ovarian, Fallopian Tube Or Primary Peritoneal Carcinoma

    Eligibility: Patients with histological documented epithelial ovarian, fallopian tube carcinoma or primary peritoneal cancer (advanced or metastatic disease). Minimum of 1 and maximum of 2 prior chemotherapy regimens, one of which must be platinum containing.

    Objectives: To assess the efficacy (response rate) of sunitinib given orally daily for 4 out of every 6 weeks in patients with advanced or metastatic previously treated epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. To assess the toxicity of sunitinib in patients with advanced or metastatic previously treated epithelial ovarian, fallopian tube or primary peritoneal carcinoma. To document CA125 response rate, early objective progression rate, and, if objective responses are observed, response duration.

    NCT Registration ID (from clinicaltrials.gov): NCT00388037
    Participation: Limited to invited centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: November 10, 2006 Closing Date: April 17, 2008



    		Permanently Closed
    I25

    NCIC CTG Phase II Study of Trimetrexate in Ovary


    NCIC CTG Phase II Study of Trimetrexate in Ovary

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 28, 1986 Closing Date: May 02, 1988



    		Permanently Closed
    I184

    A Phase II Study of Sunitinib, an Oral Multi-Targeted Tyrosine Kinase Inhibitor, in Patients with Unresectable, Locally Advanced or Metastatic Cervical Carcinoma


    A Phase II Study of Sunitinib, an Oral Multi-Targeted Tyrosine Kinase Inhibitor, in Patients with Unresectable, Locally Advanced or Metastatic Cervical Carcinoma

    Eligibility: Patients with histological/cytological documented squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma of the cervix (advanced, recurrent or persistent disease). Maximum of 1 prior chemotherapy regimen for metastatic disease. Prior neoadjuvant, adjuvant or concurrent chemoradiartion is permitted.

    Objectives: To assess the efficacy (objective response rate) of sunitinib given orally daily for 4 out of every 6 weeks in patients with unresectable, locally advanced or metastatic carcinoma of the cervix. To assess the toxicity of sunitinib in patients with unresectable, locally advanced or metastatic carcinoma of the cervix. To document time to progression, early objective progression rate, and, if objective responses are observed, response duration.

    NCT Registration ID (from clinicaltrials.gov): NCT00389974
    Participation: Limited to invited centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: November 09, 2006 Closing Date: May 12, 2008



    		Permanently Closed
    I102

    NCIC CTG Phase II Study of BMS-182751 (JM-216) in Patients With Advanced and/or Recurrent Squamous Cell Carcinoma of the Cervix


    NCIC CTG Phase II Study of BMS-182751 (JM-216) in Patients With Advanced and/or Recurrent Squamous Cell Carcinoma of the Cervix

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 27, 1997 Closing Date: February 16, 1999



    		Permanently Closed
    I192

    A Phase II Study of Ridaforolimus in Patients with Metastatic and/or Locally Advanced Recurrent Endometrial Cancer


    A Phase II Study of Ridaforolimus in Patients with Metastatic and/or Locally Advanced Recurrent Endometrial Cancer

    Complexity Level: 2

    Eligibility: Patients with histologically documented endometrial cancer. Clinically and/or radiologically documented disease. Unidimensionally measurable disease. Tumour tissue available from primary tumour to assess molecular markers of deforolimus activation. Prior hormonal treatment (adjuvant or metastatic), but no prior chemotherapy permitted.

    Objectives: To assess the efficacy (response rate and duration of stable disease) of ridaforolimus given orally, once daily, 5 days/week continuously in patients with metastatic and/or locally advanced recurrent carcinoma of the endometrium. To assess the adverse events, time to progression and response duration of ridaforolimus in patients with metastatic and/or locally advanced recurrent carcinoma of the endometrium. To correlate objective tumour response with PTEN expression in the tumour tissue obtained at diagnosis (primary tumour).

    NCT Registration ID (from clinicaltrials.gov): NCT00770185
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 26, 2008 Closing Date: August 11, 2010



    		Permanently Closed
    I149

    A Phase II Study Of OSI-774 (NSC 718781) Given In Combination With Carboplatin In Patients With Recurrent Epithelial Ovarian Cancer


    A Phase II Study Of OSI-774 (NSC 718781) Given In Combination With Carboplatin In Patients With Recurrent Epithelial Ovarian Cancer

    Eligibility: Patients with histologically documented epithelial ovarian cancer. Clinically and/or radiologically documented disease. Unidimensionally measurable disease. Tumour tissue available from primary tumour to assess EGFR status. Up to 2 prior chemotherapy regimens with the first regimen containing carboplatin or cisplatin. Patients MUST have responded to platinum based first-line chemotherapy. No prior EGFR targeting therapy permitted.

    Objectives: To assess the efficacy (response rate and duration of stable disease) of OSI-774 given daily to patients with advanced ovarian carcinoma who are reveiving carboplatin. To assess toxicity, time to progression and response duration of OSI-774 in this patient population. To correlate objective tumour response with EGFR status from primary tumour in these patients. To explore patterns of change in EGFR markers in patients that have biopsies and/or ascitic taps (additional investigations). To assess CA 125 response in patients with elevated CA 125 levels at study entry.

    NCT Registration ID (from clinicaltrials.gov): NCT00030446
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 10, 2002 Closing Date: June 01, 2004



    		Permanently Closed
    I148

    A Phase II Study of OSI-774 (NSC 718781) in Patients With Locally Advanced and/or Metastatic Carcinoma of the Endometrium


    A Phase II Study of OSI-774 (NSC 718781) in Patients With Locally Advanced and/or Metastatic Carcinoma of the Endometrium

    Eligibility: Patients with histologically documented endometrial cancer. Clinically and/or radiologically documented disease. Unidimensionally measurable disease. Tumour tissue available from primary tumour to assess EGFR status. Patients may have had up to one prior hormonal treatment (adjuvant or metastatic). No prior chemotherapy permitted. No prior EGFR targeting therapy permitted.

    Objectives: To assess the efficacy (response rate and duration of stable disease) of OSI-774 given daily to patients with advanced/metastatic carcinoma of the endometrium. To assess toxicity, time to progression and response duration of OSI-774 in this patient population. To correlate objective tumour response with EGFR expression from primary tumour in these patients. To explore patterns of change in markers of EGFR activation in patients that have biopsies (additional investigations).

    NCT Registration ID (from clinicaltrials.gov): NCT00030485
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 10, 2002 Closing Date: March 16, 2004



    		Permanently Closed
    I126

    A Phase II Study of Letrozole in Patients With Advanced or Recurrent Endometrial Cancer


    A Phase II Study of Letrozole in Patients With Advanced or Recurrent Endometrial Cancer

    NCT Registration ID (from clinicaltrials.gov): NCT00004251
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 19, 2000 Closing Date: May 16, 2001



    		Permanently Closed
    I105

    NCIC CTG Phase II Study of 776C85 Plus 5FU in Head and Neck Cancer


    NCIC CTG Phase II Study of 776C85 Plus 5FU in Head and Neck Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: February 10, 1997 Closing Date: February 22, 1999



    		Permanently Closed
    I157 (PHL002)

    A Phase I/II Study of OSI-774 in Combination With Cisplatin in Patients With Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck (Princess Margaret Hospital Phase II Consortium - PHL 002)


    A Phase I/II Study of OSI-774 in Combination With Cisplatin in Patients With Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck (Princess Margaret Hospital Phase II Consortium - PHL 002)

    Eligibility: Recurrent, unresectable and/or metastatic squamous cell cancer of the head and neck; no prior chemotherapy for recurrent/metastatic disease; unidimensionally measurable disease; patients must have completed any prior radiotherapy > 4 weeks before study entry

    Objectives: To determine the objective response rate of OSI-774 in combination with cisplatin in patients with recurrent or metastatic squamous cell cancer of the head and neck.

    NCT Registration ID (from clinicaltrials.gov): NCT00030576
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: February 10, 2003 Closing Date: September 22, 2004



    		Permanently Closed
    I244

    A Phase 2 Study of Ibrutinib Combination Therapy in Transplant Ineligible Individuals with Newly Diagnosed Primary Central Nervous System Lymphoma

    The purpose of this study is to test the good and bad effects of the drug called ibrutinib in patients with newly diagnosed primary central nervous system lymphoma. Each of the first 6 cycles of treatment will be 14 days long, and patients will receive methotrexate and rituximab (where available) on the first day of each cycle and ibrutinib on days 6-14 of each cycle. In cycle 7 onwards each cycle of treatment will be 28 days, and patients will take ibrutinib every day. Treatment will continue for two years from the first drug administration or until the patient’s disease progresses, whichever comes first. The study doctors hope to learn if adding ibrutinib to the usual treatment of methotrexate and rituximab will increase the number of patients whose cancer does not worsen after one year.

    A Phase 2 Study of Ibrutinib Combination Therapy in Transplant Ineligible Individuals with Newly Diagnosed Primary Central Nervous System Lymphoma

    Complexity Level: 1

    Eligibility: Patients (≥18 y/o, ECOG PS 0-2, 3 if due to PCNSL & expected to reverse with treatment) must have histological/cytological evidence of PCNSL; vitreo-retinal/CSF disease eligible with CNS involvement on MRI. No 2° CNS non Hodgkin lymphoma or significant 3rd space fluid which can’t be drained. Must be ineligible for high-dose chemo & ASCT, fit to receive protocol Tx. Consent to release tumour block. No prior radiation/systemic Tx except corticosteroids for PCNSL. ≤ 8mg/day of dexamethasone (or equivalent) at enrolment & wean within 7 days of starting Tx. Major surgery ≥28 days before enrolment (unless for PCNSL) & wounds healed. Able to swallow oral meds, no known GI impairment. No active Tx for other advanced/metastatic malignancy. No serious illnesses/medical conditions precluding management per protocol, no clinically significant cardiac disease (pts with history of cardiac disease: LVEF ≥50%). No anticoagulation with warfarin/equivalent or strong CYP3A inhibitor/inducer.

    Objectives: Primary: One year progression-free survival (PFS). Secondary: Overall Response Rate (ORR = CR+CRu+PR) and complete response (CR) rate; 1-year event-free survival (EFS); 2-year PFS; Overall survival (OS); To determine the safety and tolerability of ibrutinib, methotrexate, and rituximab treatment in patients with primary central nervous system lymphoma (PCNSL); To determine the impact on patient related outcomes of ibrutinib, methotrexate, and rituximab treatment in patients with PCNSL - Cognitive functioning, Health-related quality of life (FACT-BR) and cognitive symptoms (FACT-Cog). Tertiary: Baseline and serial plasma and cerebrospinal fluid circulating tumour DNA, correlated with outcomes; Radiomic evaluation of predictors of disease response and relapse

    NCT Registration ID (from clinicaltrials.gov): NCT05998642
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Open to Accrual
    Activation Date: October 24, 2023



    		Open to Accrual
    I150

    A Phase II Study of PS-341 (NSC 681239) in Patients With Untreated or Relapsed Mantle Cell Lymphoma


    A Phase II Study of PS-341 (NSC 681239) in Patients With Untreated or Relapsed Mantle Cell Lymphoma

    Eligibility: Histologically documented mantle cell lymphoma (at initial diagnosis) non-refractory to prior therapy or no prior therapy. Pathology will be reviewed by the Central Reference Pathologist at BCCA to confirm eligibility. Bidimensionally measurabe disease. O-2 prior chemotherapy regimens; not permitted: radioactive MoAb therapy, high dose chemotherapy with stem cell transplant or prior investigational therapy. Prior radiation permitted if < 25% functioning bone marrow; prior surgery permitted.

    Objectives: To assess efficacy of PS-341 given as a bolus IV injection twice weekly for two out of three weeks. To assess the toxicity of PS-341 when administered on this schedule in this patient group. To determine 20S proteasome levels in whole blood and correlate suppression of this marker with toxicity and response to PS-341.

    NCT Registration ID (from clinicaltrials.gov): NCT00030875
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 04, 2002 Closing Date: July 28, 2004



    		Permanently Closed
    I78

    NCIC CTG Phase II Study of Didemnin-B in Previously Untreated Patients With Favourable Histology Lymphoma


    NCIC CTG Phase II Study of Didemnin-B in Previously Untreated Patients With Favourable Histology Lymphoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: September 01, 1993 Closing Date: October 25, 1994



    		Permanently Closed
    I191

    A Phase II Study of AT9283 in Patients with Relapsed or Refractory Multiple Myeloma


    A Phase II Study of AT9283 in Patients with Relapsed or Refractory Multiple Myeloma

    Complexity Level: 2

    Eligibility: Patients must have a confirmed diagnosis of multiple myeloma and measurable disease, according to internationally accepted criteria for myeloma. Patients must have received prior treatment for multiple myeloma, and have relapsed or progressed on prior therapy. No more than three prior regimens; prior treatment must be completed at least 4 weeks prior to registration. ECOG performance status must be 0, 1 or 2; adequate hematologic and organ function.

    Objectives: To assess the efficacy of AT9283 when given as a 24 hour infusion on Days 1 and 8 every three weeks to patients with relapsed or refractory multiple myeloma; to determine the adverse effects of AT9283; to evaluate potential predictive and prognostic biomarkers (marrow, blood); and to evaluate disease-related symptoms including pain, fatigue and mucositis.

    NCT Registration ID (from clinicaltrials.gov): NCT01145989
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 15, 2010 Closing Date: July 26, 2012



    		Permanently Closed
    I193

    A Phase II Study of AT7519M, A CDK Inhibitor in Patients with Relapsed and/or Refractory Chronic Lymphocytic Leukemia.


    A Phase II Study of AT7519M, A CDK Inhibitor in Patients with Relapsed and/or Refractory Chronic Lymphocytic Leukemia.

    Complexity Level: 2

    Eligibility: Patients with documented chronic lymphocytic leukemia with at least one and up to 3 prior systemic treatment regimens. Patients must have either lymphocyte count >= 10 x 109/L or at least one measurable lymph node >= 2 cm x 2 cm to be eligible. No pre-existing cardiovascular conditions or symptomatic cardiac dysfunction. Acceptable end-organ function. ECOG 0, 1 or 2.

    Objectives: To assess the efficacy of AT7519M when given as a 1 hour intravenous infusion twice weekly for two out of three weeks in patients with relapsed and/or refractory chronic lymphocytic leukemia. To assess the toxicity, time to progression and response duration of AT7519M in patients with relapsed/refractory CLL. To demonstrate the pharmacodynamic activity of AT7519M in patients with relapsed and/or refractory CLL by establishing its effects on relevant biological endpoints (markers of CDK inhibition, apoptotic markers and cell cycle suppressors) in circulating lymphocytes. To investigate the relationship between baseline cytogenetics and other molecular markers in response to AT7519M.

    NCT Registration ID (from clinicaltrials.gov): NCT01627054
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 21, 2012 Closing Date: November 22, 2013



    		Permanently Closed
    I84

    NCIC CTG Phase I Study of Topotecan and Etoposide in Patients With Refractory or Relapsed Acute Leukemia


    NCIC CTG Phase I Study of Topotecan and Etoposide in Patients With Refractory or Relapsed Acute Leukemia

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: December 07, 1994 Closing Date: November 23, 1995



    		Permanently Closed
    I20

    NCIC CTG Phase II Study of Menogaril in Lymphoma


    NCIC CTG Phase II Study of Menogaril in Lymphoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: May 30, 1985 Closing Date: November 14, 1988



    		Permanently Closed
    I16

    NCIC CTG Phase II Study of Acivicin in Lymphoma


    NCIC CTG Phase II Study of Acivicin in Lymphoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: November 12, 1984 Closing Date: October 30, 1987



    		Permanently Closed
    I100

    NCIC CTG Phase II Combination Trial of Topotecan and Etoposide in Patients with AML


    NCIC CTG Phase II Combination Trial of Topotecan and Etoposide in Patients with AML

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: October 09, 1996 Closing Date: May 13, 1998



    		Permanently Closed
    I172

    Phase II Study Of Bortezomib And Gemcitabine In Patients With Relapsed Mantle Cell Lymphoma.


    Phase II Study Of Bortezomib And Gemcitabine In Patients With Relapsed Mantle Cell Lymphoma.

    Eligibility: Histologically documented mantle cell lymphoma non-refractory to prior therapy. Pathology will be reviewed by the Central Reference Pathologist at BCCA to confirm eligibility. Bidimensionally measurabe disease. 1-2 prior chemotherapy regimens; not permitted: radioactive MoAb therapy, high dose chemotherapy with stem cell transplant or prior PS-341/bortezomib or other investigational therapy (excluding flavopiridol). Prior radiation permitted if < 25% functioning bone marrow; prior surgery permitted. Adequate organ function; no pre-existing edema, neuropathy or dyspnea >= gr 2 or ascites or pleural effusions. No serious cardiovascular disease and adequate cardiac function - LVEF >= 45%.

    Objectives: To determine the efficacy (response rate) of bortezomib given as a bolus intravenous injection twice weekly for 2 out of 3 weeks in combination with gemcitabine given as a 30 min. intravenous infusion once weekly for two consecutive weeks in patients with relapsed mantle cell lymphoma. To assess the toxicity of this combination as well as time to progression and response duration.

    NCT Registration ID (from clinicaltrials.gov): NCT00377052
    Participation: Limited to selected centres.
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 14, 2006 Closing Date: September 19, 2008



    		Permanently Closed
    I62

    NCIC CTG Phase II Study of Subcutaneous R-Interleukin-2 Plus Interferon Alfa-2a in Previously Treated Patients With Multiple Myeloma


    NCIC CTG Phase II Study of Subcutaneous R-Interleukin-2 Plus Interferon Alfa-2a in Previously Treated Patients With Multiple Myeloma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: October 07, 1991 Closing Date: February 17, 1993



    		Permanently Closed
    I182

    A Phase II Study Of Sunitinib (SU11248; NSC 736511; IND 74019), An Oral Multi-Targeted Tyrosine Kinase Inhibitor, In Patients With Relapsed Or Refractory Diffuse Large B-Cell Lymphoma


    A Phase II Study Of Sunitinib (SU11248; NSC 736511; IND 74019), An Oral Multi-Targeted Tyrosine Kinase Inhibitor, In Patients With Relapsed Or Refractory Diffuse Large B-Cell Lymphoma

    Eligibility: - Histologically documented diffuse large B-cell or mediastinal (thymic) large B-cell lymphoma, advanced or metastatic disease. - Patients must have received at least one, and up to two prior chemotherapy regimens, one of which must have been doxorubicin-based. - Patients may be relapsed post stem cell transplant as the preparative regimen and high dose chemotherapy will be considered as one regimen. Patients may have received one other non-chemotherapy regimen in the form of radiation. - No prior therapy with angiogenesis inhibitors or multi-targeted tyrosine kinase inhibitors - > 28 days since prior chemotherapy, hormonal therapy, radiation therapy or major surgery - Bidimensionally measurable disease; no known brain metastases - ECOG performance status: 0 or 1 - No serious medical conditions or cardiac disease (as specified in protocol); no uncontrolled hypertension

    Objectives: 1. To assess the efficacy (response rate) of sunitinib given orally daily in patients with relapsed or refractory diffuse or thymic (mediastinal) large B-cell lymphoma. 2. To assess the toxicity of sunitinib in patients with relapsed or refractory diffuse or thymic (mediastinal) large B-cell lymphoma. 3. To assess the effects of sunitinib on the peripheral blood biomarkers circulating endothelial cells (CECs) and their precursors (CEPs) in patients with relapsed or refractory diffuse or thymic (mediastinal) large B-cell lymphoma.

    NCT Registration ID (from clinicaltrials.gov): NCT00392496
    Participation: Limited to invited centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: November 08, 2006 Closing Date: March 24, 2009



    		Permanently Closed
    I127

    A Phase II Study of Flavopiridol (HMR 1275; NSC 649890) in Patients With Untreated or Relapsed Mantle Cell Lymphoma


    A Phase II Study of Flavopiridol (HMR 1275; NSC 649890) in Patients With Untreated or Relapsed Mantle Cell Lymphoma

    Eligibility: Histologically or cytologically documented mantle cell lymphoma (at initial diagnosis) non-refractory to prior therapy or with no prior therapy. Pathology must be reviewed by the Central Reference Pathologist at BCCA to confirm eligibility BEFORE patient registration if questionable. Presence of clinically and/or radiologically documented disease. 0-2 prior chemotherapy regimens permitted. Prior radiation permitted if < 25% functioning bone marrow; prior surgery permitted.

    Objectives: To assess the efficacy of flavopiridol, given as a 3 day bolus every 21 days. To assess the toxicity of flavopiridol when administered on this schedule in the patient group.

    NCT Registration ID (from clinicaltrials.gov): NCT00005074
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 24, 2000 Closing Date: October 10, 2001



    		Permanently Closed
    I216

    Phase II Study of Buparlisib in Patients with Relapsed and Refractory Chronic Lymphocytic Leukemia


    Phase II Study of Buparlisib in Patients with Relapsed and Refractory Chronic Lymphocytic Leukemia

    Complexity Level: 2

    Eligibility: Patients with previously documented CLL that is recurrent or relapsed after previous therapy and that requires treatment. Patient must have at least one of the following: lymphocyte count >or= 10 x 10/9/L OR at least one pathologically enlarged lymph node (>or= 2 x 2 cm) by CT scan. Patients must have received at least 1 prior systemic treatment regimen (single agent or combination therapy) and recovered from all reversible toxicity related to prior chemotherapy and have adequate washout period. ECOG 0-2. At least 14 days since major surgery and 21 days since prior radiation therapy.

    Objectives: To determine the overall response rate (complete + partial response). To evaluate the safety and tolerability of buparlisib. To evaluate additional measures of efficacy including duration of response rate and progression free survival. To explore potential molecular factors which may be prognostic or predictive of response or of relapse including: correlation between clinical response and MTT assay in B-CLL exposed ex-vivo to buparlisib; correlation between response to buparlisib and western blot and flow cytometry analysis of key proteins involved in the PI3K pathway; identification of mechanisms of resistance among patients who relapse after therapy with buparlisib; to prospectively validate a survival prediction scale.

    NCT Registration ID (from clinicaltrials.gov): NCT02340780
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Permanently Closed
    Activation Date: January 30, 2015 Closing Date: January 24, 2017



    		Permanently Closed
    I145

    A Phase II Study of ZD6474 in Patients With Relapsed Multiple Myeloma


    A Phase II Study of ZD6474 in Patients With Relapsed Multiple Myeloma

    Eligibility: Patients with confirmed diagnosis of multiple myeloma with a measurable serum or urine M-component at initial diagnosis. Patients must have relapsed following first or second line oral alkylating therapy or high dose chemotherapy and stem cell transplant. Patients are not eligible if they relapsed during prior treatment, have had > 2 prior chemotherapy regimens or relapsed within 3 months after last treatment.

    Objectives: To assess the efficacy of ZD6474 when given orally to patients with relapsed previously treated multiple myeloma. To determine the toxic effects, duration of response, time to progression, and pharmacokinetics profile and characteristics, as well as to examine bone marrow samples in patients with multiple myeloma given ZD6474.

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: October 02, 2002 Closing Date: April 08, 2004



    		Permanently Closed
    I186

    A Phase I/II Study of Sorafenib (BAY 43-9006) In Combination With Low Dose ARA-C (Cytarabine) In Elderly Patients With AML Or High-Risk MDS


    A Phase I/II Study of Sorafenib (BAY 43-9006) In Combination With Low Dose ARA-C (Cytarabine) In Elderly Patients With AML Or High-Risk MDS

    Complexity Level: 1

    Eligibility: Patients age > 60 years and not suitable for intensive chemotherapy regimens with pathologically confirmed AML or high-risk MDS. o ECOG performance status 0, 1, or 2 o Prior Chemotherapy: None except hydroxyurea permitted provided discontinued > 48 hours prior to start of protocol therapy o Biochemistry: bilirubin and creatinine within normal limits, AST/ALT < 2 x UNL o No documented CNS involvement o No serious medical condition including: significant neurologic or psychiatric disorder, active uncontrolled infection

    Objectives: Phase I Portion: To determine the recommended dose of sorafenib and Ara-C given in combination in elderly patients with AML or high-risk MDS who are not suitable for intensive chemotherapy. To determine the safety, tolerability, toxicity profile and dose limiting toxicities of the combination sorafenib and Ara-C in this patient population. Phase II Portion: To estimate the efficacy (as measured by complete response rate) of the recommended dose of sorafenib given orally in combination with Ara-C in elderly patients with AML or high-risk MDS. To describe the toxic effects and overall response rate (complete plus partial) in this population. To evaluate potential correlates of response in translational research studies including FLT-3 ITD's and point mutations in blasts.

    NCT Registration ID (from clinicaltrials.gov): NCT00516828
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 24, 2007 Closing Date: December 10, 2009



    		Permanently Closed
    I108

    A Phase II Study of Topotecan and Etoposide in Patients With Intermediate Grade Non-Hodgkin's Lymphoma


    A Phase II Study of Topotecan and Etoposide in Patients With Intermediate Grade Non-Hodgkin's Lymphoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 05, 1997 Closing Date: May 07, 1998



    		Permanently Closed
    I152 (IND.152)

    A Phase II Study of PS-341 (NSC 681239) in Patients With Untreated or Relapsed Waldenstrom's Macroglobulinemia


    A Phase II Study of PS-341 (NSC 681239) in Patients With Untreated or Relapsed Waldenstrom's Macroglobulinemia

    Eligibility: Confirmed diagnosis of Waldenstrom's Macroglobulinemia. If newly diagnosed or untreated must have IgM > 20 g/L, if previously treated IgM must be > 5g/L at time of registration. Must be symptomatic. O-2 prior chemotherapy regimens, non-refractory to prior therapy; not permitted: radioactive MoAb therapy, high dose chemotherapy with stem cell transplant. Prior radiation permitted if < 25% functioning bone marrow; prior surgery permitted.

    Objectives: To assess efficacy of PS-341 given as a bolus IV injection twice weekly for two out of three weeks. To assess the toxicity of PS-341 when administered on this schedule in this patient group. To assess bone marrow and peripheral blood for cytogenetics and genome profiling by microarray.

    NCT Registration ID (from clinicaltrials.gov): NCT00045695
    Participation: Limited to invited centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 27, 2002 Closing Date: March 23, 2005



    		Permanently Closed
    I194

    A Phase II Study of AT7519M, a CDK Inhibitor, in Patients with Relapsed Mantle Cell Lymphoma


    A Phase II Study of AT7519M, a CDK Inhibitor, in Patients with Relapsed Mantle Cell Lymphoma

    Complexity Level: 2

    Eligibility: Patients with documented mantle cell lymphoma non-refractory to prior therapy. Patients must have received at least one and up to 3 prior systemic treatment regimens. Patients must have at least one site of bidimensional disease to be eligible. No pre-existing cardiovascular conditions or symptomatic cardiac dysfunction. Acceptable end-organ function. ECOG 0, 1 or 2.

    Objectives: Primary: To assess the efficacy (as assessed by objective response rate) of AT7519M when given as a 1 hour intravenous infusion twice weekly for two out of three weeks in patients with relapsed mantle cell lymphoma (MCL). Secondary: - To assess the toxicity, time to progression and response duration of AT7519M in patients with relapsed mantle cell lymphoma. - To explore potential proteomic and metabolic serum markers of clinical response to AT7519M in MCL by assessment of peripheral blood collected at baseline and on study.

    NCT Registration ID (from clinicaltrials.gov): NCT01652144
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 24, 2012 Closing Date: May 07, 2014



    		Permanently Closed
    I3

    NCIC CTG Phase II Study of Spirogermanium in Poor Prognosis Non-Hodgkin's Lymphoma


    NCIC CTG Phase II Study of Spirogermanium in Poor Prognosis Non-Hodgkin's Lymphoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: February 09, 1983 Closing Date: May 14, 1984



    		Permanently Closed
    I22

    NCIC CTG Phase II Study of Deoxycoformycin in Hairy Cell


    NCIC CTG Phase II Study of Deoxycoformycin in Hairy Cell

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 26, 1985 Closing Date: July 15, 1986



    		Permanently Closed
    I141

    A Randomized Phase I Study of Two Different Schedules of BAY 43-9006 in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome


    A Randomized Phase I Study of Two Different Schedules of BAY 43-9006 in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome

    Eligibility: Acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS), not requiring urgent cytoreductive therapy. One prior chemotherapy regimen permitted.

    Objectives: To determine the maximum tolerated doses (MTD) and the recommended doses (RD) of two different schedules of BAY 43-9006 in patients with AML or MDS. To determine toxic effects, pharmacokinetics, gene expression, target effects and clinical response rates of BAY-43-9006 in this patient population.

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: October 01, 2001 Closing Date: April 01, 2004



    		Permanently Closed
    I242

    Neoadjuvant Platform Trial in Patients with Surgically Resectable Non-Small Cell Lung Cancer (NSCLC)

    The purpose of the pre-study screening is to test for biomarkers. The testing will be done using a sample of your tumor tissue. . Each substudy will be looking at what effects a new drug has on the patients and their lung cancer, as well as any side effects of the treatment. The purpose of each substudy is to see if the biomarkers that were identified at screening can be used to determine treatment outcomes, like how the cancer cells respond to treatment and whether the study drug will shrink the tumour before surgery and prevent it from returning after surgery.

    Neoadjuvant Platform Trial in Patients with Surgically Resectable Non-Small Cell Lung Cancer (NSCLC)

    Complexity Level: 1

    Eligibility: Histologically confirmed diagnosis of primary NSCLC within 90 days of enrollment to a substudy, according to WHO/ classified as Stage IA2 to IIIA according to the AJCC 8th edition TNM classification with disease that is amenable to anatomical surgical resection. Patients with multistation N2.; must be ≥ 18 years of age. No prior anticancer therapy for treatment of NSCLC. Patients with a history of NSCLC treated in the curative setting may be eligible but must be discussed with CCTG prior to enrollment, ECOG performance status of 0 or 1; synchronous primary tumours may be eligible if all of the following conditions are met:, surgery must be performed between 2 to 4 weeks following the last dose of neoadjuvant therapy, adequate organ and marrow function.

    Objectives: To identify promising neoadjuvant treatment regimens for NSCLC for later validation in randomized clinical trials, by evaluating major pathological response rates (MPR). Secondary, to summarize the safety and tolerability of each regimen and to evaluate other indicators of activity such as: Overall response rate (ORR) using RECIST 1.1 (and other criteria such as iRECIST as applicable) for neoadjuvant treatment period; Complete pathological response (cPR) rate; Event-free survival rate at 2 years; and Surgical outcomes, including completeness of surgical resection, extent and access to surgery, extent of perihilar/lobar fibrosis or mediastinal adhesions and tumour downstaging. Exploratory include: To identify potential predictive biomarkers of response and mechanisms of resistance, and explore patient related outcomes (PRO).

    NCT Registration ID (from clinicaltrials.gov): NCT05714891
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Open to Accrual
    Activation Date: May 26, 2023



    		Open to Accrual
    I242A

    A Phase II Pre-operative Trial of JDQ433 in Patients with Surgically Resectable Non-Small Cell Lung Cancer (NSCLC)


    A Phase II Pre-operative Trial of JDQ433 in Patients with Surgically Resectable Non-Small Cell Lung Cancer (NSCLC)

    Complexity Level: 1

    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: CCTG Led Trial
    Status: Closed to Accrual
    Activation Date: May 26, 2023 Closing Date: May 08, 2024



    		Closed to Accrual
    I215

    A Phase Ib Study of Selumetinib in Patients with Previously Treated or Untreated Advanced/Metastatic NSCLC Who are Receiving Standard Chemotherapy Regimens.


    A Phase Ib Study of Selumetinib in Patients with Previously Treated or Untreated Advanced/Metastatic NSCLC Who are Receiving Standard Chemotherapy Regimens.

    Complexity Level: 1

    Eligibility: Patients with histologic and/or cytologic confirmed non-small cell lung cancer that is metastatic or unresectable and for which standard curative measures do not exist. Patients accrued to the pemetrexed single agent cohort as well as those accrued to the RP2D expansion cohorts must have documented KRAS mutation, as well as at least one site of disease which is unidimensionally measurable. Patient must have a formalin fixed paraffin embedded tissue block (from their primary or metastatic tumour). At least 14 days since major surgery, 4 weeks since radiation therapy. ECOG 0-1. Age > 18 years. No prior MEK inhibitors or any other tyrosine kinase inhibitor.

    Objectives: Primary Objective: To determine the recommended phase II dose (RP2D) and safety profile of selumetinib in patients with advanced/metastatic NSCLC in combination with: pemetrexed; pemetrexed and cisplatin; paclitaxel and carboplatin. Secondary Objectives: 1) to obtain pharmacokinetic (PK) profiles of selumetinib when given daily continuously in combination with chemotherapy; 2) to explore gene expression signatures/profiles and/or KRAS codon subtypes in tumour and/or tumour derived material that may influence response; the use of plasma as a potential source of circulating free tumour DNA (cfDNA) for the analysis of KRAS mutation status; and serum exploratory markers that may predict response to selumetinib; 3) preliminary assessment of efficacy in all patients and in an expansion cohort of up to 10 patients with KRAS positive NSCLC.

    NCT Registration ID (from clinicaltrials.gov): NCT01783197
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 30, 2013 Closing Date: October 16, 2015



    		Permanently Closed
    I30

    NCIC CTG Phase II Study of VP-16/Cisplatin in Mesothelioma


    NCIC CTG Phase II Study of VP-16/Cisplatin in Mesothelioma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 09, 1986 Closing Date: April 01, 1987



    		Permanently Closed
    I207

    A Phase II Study of PF-03446962 in Patients with Advanced Malignant Pleural Mesothelioma


    A Phase II Study of PF-03446962 in Patients with Advanced Malignant Pleural Mesothelioma

    Complexity Level: 2

    Eligibility: histologically or cytologically confirmed malignant pleural mesothelioma; advanced and/or metastatic disease; at least one site of disease must be unidimensionally measurable; patients are eligible after first line cytotoxic chemotherapy has failed; patients must have received one, but no more than one, combination chemotherapy regimen for advanced disease, which must have contained platinum based chemotherapy

    Objectives: To assess the efficacy of PF-03446962 given by IV day 1 of a 2 week cycle in patients with advanced malignant pleural mesothelioma; to assess the toxicity, safety and tolerability of PF-03446962; to assess the duration of response or stable disease, stable disease rate, progression free, median and overall survival rates; to collect tissue and blood for banking and correlative science evaluation.

    NCT Registration ID (from clinicaltrials.gov): NCT01486368
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Permanently Closed
    Activation Date: November 30, 2011 Closing Date: January 09, 2014



    		Permanently Closed
    I42

    NCIC CTG Phase II Study of Amonafide in Small Cell Lung Cancer


    NCIC CTG Phase II Study of Amonafide in Small Cell Lung Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: October 23, 1987 Closing Date: April 25, 1988



    		Permanently Closed
    I183

    A Phase II Study Of Sunitinib In Patients With Advanced Malignant Pleural Mesothelioma


    A Phase II Study Of Sunitinib In Patients With Advanced Malignant Pleural Mesothelioma

    Eligibility: Patients with histological or cytological documented malignant pleural mesothelioma (advanced or metastatic disease). There will be two groups: Cohort 1 - previously treated patients: minimum of one prior platinum based chemotherapy, and Cohort 2 - previously untreated patients: No prior cytotoxic therapy permitted.

    Objectives: To assess the efficacy (response rate, complete and partial) of sunitinib given orally daily for 4 out of every 6 weeks in patients with malignant pleural mesothelioma in two cohorts: in patients previously treated with cytotoxic therapy (cohort 1) and in patients who have not received previous cytotoxic therapy (cohort 2). To assess the toxicity safety and tolerability of sunitinib. To assess the duration of response or stable disease, stable disease rate, progression-free, median and overall survival rates

    NCT Registration ID (from clinicaltrials.gov): NCT00392444
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: November 10, 2006 Closing Date: September 10, 2010



    		Permanently Closed
    I69

    NCIC CTG Phase II Study of Taxotere in Patients With Extensive Small Cell Lung Cancer


    NCIC CTG Phase II Study of Taxotere in Patients With Extensive Small Cell Lung Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: February 08, 1993 Closing Date: October 18, 1993



    		Permanently Closed
    I17

    NCIC CTG Phase I Study of Acivicin/Cisplatin in Non-Small Cell Lung Cancer


    NCIC CTG Phase I Study of Acivicin/Cisplatin in Non-Small Cell Lung Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: March 01, 1985 Closing Date: April 25, 1988



    		Permanently Closed
    I50

    NCIC CTG Phase II Study of Gemcitabine in Small Cell Lung Cancer


    NCIC CTG Phase II Study of Gemcitabine in Small Cell Lung Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: February 04, 1991 Closing Date: September 29, 1992



    		Permanently Closed
    I52

    NCIC CTG Phase I Study of GMCSF in Small Cell Lung Cancer


    NCIC CTG Phase I Study of GMCSF in Small Cell Lung Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: November 06, 1989 Closing Date: September 19, 1990



    		Permanently Closed
    I31

    NCIC CTG Phase II Study of VP-16/Carboplatin in Extensive Small Cell Lung Cancer


    NCIC CTG Phase II Study of VP-16/Carboplatin in Extensive Small Cell Lung Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: December 18, 1985 Closing Date: October 09, 1986



    		Permanently Closed
    I57

    NCIC CTG Phase II Study of DUP937 in Non-Small Cell Lung Cancer


    NCIC CTG Phase II Study of DUP937 in Non-Small Cell Lung Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 04, 1991 Closing Date: April 02, 1992



    		Permanently Closed
    I120

    A Phase II Study of Troxacitabine in Patients With Advanced Non-Small Cell Lung Cancer


    A Phase II Study of Troxacitabine in Patients With Advanced Non-Small Cell Lung Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 16, 1999 Closing Date: May 30, 2000



    		Permanently Closed
    I219

    A Randomized Phase II Trial of Selumetinib in Patients Receiving Standard Pemetrexed and Platinum-Based Chemotherapy for the Treatment of Advanced or Metastatic KRAS Wildtype or Unknown Non-Squamous Non-Small Cell Lung Cancer


    A Randomized Phase II Trial of Selumetinib in Patients Receiving Standard Pemetrexed and Platinum-Based Chemotherapy for the Treatment of Advanced or Metastatic KRAS Wildtype or Unknown Non-Squamous Non-Small Cell Lung Cancer

    Complexity Level: 2

    Eligibility: Patients with histologically and/or cytologically confirmed stage IIIB/IV non-squamous, KRAS wildtype or unknown, NSCLC that is metastatic or unresectable and for which standard curative measures do not exist. All patients must have formalin fixed paraffin embedded tissue block available for correlative studies. Must have at least one site of disease that is unidimensionally measurable. ECOG 0-1. No prior MEK inhibitors or tyrosine kinase inhibitor (including EGFR inhibitors of any kind). Prior adjuvant platinum-based chemotherapy or combined chemoradiation with curative intent is permissible if completed > 1 yr prior to enrolment. No prior cytotoxic chemotherapy for advanced/metastatic disease. No significant cardiac disease or gastrointestinal disease. No untreated brain or meningeal metastases (untreated or treated). No potent inhibitors/inducers of CYP3A4/5,CYP2C19/CYP1A2. No central serous retinopathy, retinal vein occlusion, high intraocular pressure or uncontrolled glaucoma.

    Objectives: Primary Objective: To determine the efficacy, as determined by objective response rate, of selumetinib (intermittent or continuous) in patients with NSCLC not known to have KRAS mutation receiving standard pemetrexed and cisplatin chemotherapy compared to chemotherapy alone. Secondary Objectives: To assess the tolerability of selumetinib in patients receiving pemetrexed and cisplatin, to explore the progression free survival of patients receiving selumetinib with pemetrexed and cisplatin to those receiving pemetrexed and cisplatin or carboplatin alone and to explore whether KRAS mutation, other common mutations, or tumour based molecular signatures are predictive of selumetinib effect.

    NCT Registration ID (from clinicaltrials.gov): NCT02337530
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Permanently Closed
    Activation Date: February 05, 2015 Closing Date: May 08, 2017



    		Permanently Closed
    I114

    NCIC CTG Phase II Study of Vasopression Receptor Type 1-A Antagonist SR49059 in Patients With Previously Treated Small Cell Lung Cancer


    NCIC CTG Phase II Study of Vasopression Receptor Type 1-A Antagonist SR49059 in Patients With Previously Treated Small Cell Lung Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 05, 1999 Closing Date: October 20, 2000



    		Permanently Closed
    I7

    NCIC CTG Phase II Study of Mitoxantrone in Mesothelioma


    NCIC CTG Phase II Study of Mitoxantrone in Mesothelioma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 12, 1983 Closing Date: February 15, 1985



    		Permanently Closed
    I190

    A Phase I-II Trial of MK-0646, a Monoclonal Antibody Against Insulin-Like Growth Factor-1 Receptor, in Combination with Etoposide and Cisplatin in Extensive Stage Small Cell Lung Cancer.


    A Phase I-II Trial of MK-0646, a Monoclonal Antibody Against Insulin-Like Growth Factor-1 Receptor, in Combination with Etoposide and Cisplatin in Extensive Stage Small Cell Lung Cancer.

    Eligibility: Patients with histologically confirmed, extensive stage small cell lung cancer. No prior chemotherapy for SCLC. Prior radiation permitted to brain but not to lung. No uncontrolled diabetes or cardiac conditions and acceptable end-organ function. ECOG 0, 1 or 2. Unidimensionally measurable disease.

    Objectives: 1.1 Phase I Objectives 1.1.1 To determine the recommended phase II dose of MK-0646 in combination with a standard etoposide and cisplatin (EP) chemotherapy regimen. 1.1.2 Evaluate the toxicity and preliminary efficacy of the combination. 1.2 Phase II Objectives 1.2.1 To assess the efficacy, as determined by objective response rate; including complete response rate, progression-free survival and overall survival. 1.2.2 To assess the toxicity and tolerability. 1.2.3 Explore the predictive and prognostic impact of biomarkers.

    NCT Registration ID (from clinicaltrials.gov): NCT00869752
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 30, 2009 Closing Date: March 10, 2011



    		Permanently Closed
    I80

    NCIC CTG Phase I Study of Taxol and Concurrent Radiotherapy in Non-Small Cell Lung Cancer


    NCIC CTG Phase I Study of Taxol and Concurrent Radiotherapy in Non-Small Cell Lung Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: March 14, 1994 Closing Date: June 14, 1996



    		Permanently Closed
    I33

    NCIC CTG Phase II Study of Epirubicin in Small Cell Lung Cancer


    NCIC CTG Phase II Study of Epirubicin in Small Cell Lung Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 29, 1986 Closing Date: July 31, 1987



    		Permanently Closed
    I11

    NCIC CTG Phase II Study of TCAR in Lung


    NCIC CTG Phase II Study of TCAR in Lung

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: May 01, 1985 Closing Date: March 01, 1987



    		Permanently Closed
    I2L

    NCIC CTG Phase II Study of Acivicin (AT125) in Patients With Metastatic Non-Small Cell Lung Cancer


    NCIC CTG Phase II Study of Acivicin (AT125) in Patients With Metastatic Non-Small Cell Lung Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: November 03, 1981 Closing Date: March 09, 1984



    		Permanently Closed
    I66

    Phase II Study of Interferon Alfa-2a and 13-cis-retinoic Acid in Patients With Non-Small Cell Lung Cancer


    Phase II Study of Interferon Alfa-2a and 13-cis-retinoic Acid in Patients With Non-Small Cell Lung Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 15, 1992 Closing Date: May 28, 1993



    		Permanently Closed
    I47

    NCIC CTG Phase II Study of LY186641 in Small Cell Lung Cancer


    NCIC CTG Phase II Study of LY186641 in Small Cell Lung Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: October 25, 1989 Closing Date: November 30, 1990



    		Permanently Closed
    I89

    NCIC CTG Phase II Study of LY231514 in Patients With Non-Small Cell Lung Cancer


    NCIC CTG Phase II Study of LY231514 in Patients With Non-Small Cell Lung Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: September 12, 1995 Closing Date: February 04, 1997



    		Permanently Closed
    I211

    A Randomized Phase II Study of Reolysin in Patients With Previously Treated Advanced or Metastatic, Non Small Cell Lung Cancer Receiving Standard Salvage Therapy.


    A Randomized Phase II Study of Reolysin in Patients With Previously Treated Advanced or Metastatic, Non Small Cell Lung Cancer Receiving Standard Salvage Therapy.

    Complexity Level: 2

    Eligibility: Patients with a histological or cytological diagnosis of non small cell lung cancer, that is advanced and/or metastatic, for which systemic treatment with docetaxel or pemetrexed is indicated. Tumour block available. Patients must have measurable disease as defined by RECIST 1.1. Must have received one prior regimen of pallative first line chemotherapy (must be platinum containing combination unless patient >70 years), which may not have contained docetaxel. Patients who have had concurrent platinum based chemoradiotherapy for stage 3 disease and have relapsed within 1 year of treatment may be considered to have had one prior platinum containing regimen. Prior pemetrexed first line but not maintenance therapy is permissible and prior adjuvant chemotherapy is permitted if completed at least one year prior to relapse/recurrence. ECOG 0 or 1. No neuropathy >=2.

    Objectives: Primary Objective: To evaluate the effect of reolysin in combination with either docetaxel or pemetrexed on the progression free survival of patients with advanced or metastatic non small cell lung cancer. Secondary Objectives: a) To determine the tolerability and toxicity of reolysin and docetaxel or pemetrexed when given in combination. b) To investigate additional potential measures of efficacy including: progression at 3 months, objective response rate and overall survival. c) To explore potential molecular factors predictive of response by assessment of archival tumour tissue and serial blood samples, including KRAS and EGFR status.

    NCT Registration ID (from clinicaltrials.gov): NCT01708993
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: October 15, 2012 Closing Date: August 06, 2015



    		Permanently Closed
    I110

    NCIC CTG Phase II Study of Multi-Targeted Anti-Folate (MTA) LY231514 in Combination With Cisplatin in Patients With Advanced Non-Small Cell Lung Cancer


    NCIC CTG Phase II Study of Multi-Targeted Anti-Folate (MTA) LY231514 in Combination With Cisplatin in Patients With Advanced Non-Small Cell Lung Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 15, 1998 Closing Date: June 07, 1999



    		Permanently Closed
    I196

    A Phase I/II Study of Foretinib in Patients with Previously Treated Non-Small Cell Lung Cancer Receiving Standard Erlotinib Therapy (IND.196)


    A Phase I/II Study of Foretinib in Patients with Previously Treated Non-Small Cell Lung Cancer Receiving Standard Erlotinib Therapy (IND.196)

    Complexity Level: 1

    Eligibility: Patients with locally advanced or metastatic non-small cell lung cancer who have failed at least one prior chemotherapy regimen for advanced or metastatic disease. No more than 2 prior chemotherapy regimens for advanced or metastatic disease. EGFR status positive or unknown. Unidimensionally measurable disease. Archival tissue or fresh biopsy/FNA required at study entry.

    Objectives: To determine the safety, tolerability, toxicity profile, dose limiting toxicities, pharmacokinetic profile and the recommended phase II dose of Foretinib in combination with standard erlotinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen, and whose EGFR expression status is positive or unknown. To assess the anti-tumour activity of Foretinib in combination with erlotinib as evidenced by response rates, clinical benefit (complete or partial response or stable disease > 8 weeks duration), survival and an exploratory endpoint of early assessment of tumour size as a continuous variable, when compared to erlotinib alone. To correlate response with various biomarkers.

    NCT Registration ID (from clinicaltrials.gov): NCT01068587
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: December 17, 2009 Closing Date: January 24, 2013



    		Permanently Closed
    I65

    NCIC CTG Phase II Study of Elsamitrucin in Patients With Non-Small Cell Lung Cancer


    NCIC CTG Phase II Study of Elsamitrucin in Patients With Non-Small Cell Lung Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 01, 1992 Closing Date: December 04, 1992



    		Permanently Closed
    I81

    NCIC CTG Phase II Study of Tallimustine in Patients With Previously Treated Small Cell Lung Cancer


    NCIC CTG Phase II Study of Tallimustine in Patients With Previously Treated Small Cell Lung Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 16, 1994 Closing Date: June 14, 1995



    		Permanently Closed
    I227

    A Phase II/III Randomized Study of Pembrolizumab in Patients with Advanced Malignant Pleural Mesothelioma


    A Phase II/III Randomized Study of Pembrolizumab in Patients with Advanced Malignant Pleural Mesothelioma

    Complexity Level: 2

    Eligibility: Patients must have histologically confirmed unresectable advanced and/or metastatic malignant pleural mesothelioma with available tumour block. No prior chemotherapy for advanced/metastatic disease. Prior (neo) adjuvant cisplatin-based systemic chemotherapy allowed if last dose > 12 months before registration. No prior targeted small molecule therapy, immunotherapies and viral therapies, biologic therapies and angiogenesis inhibitors for advanced/metastatic disease, or any prior immunotherapy for any stage of disease. Prior radiation therapy is permitted (< 30% BM), measurable disease outside the previously irradiated area is required. No diagnosis of immunodeficiency or is receiving systemic steroid therapy (doses > 10 mg prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to first dose of trial treatment. No active autoimmune disease requiring systemic treatment < 3 years. No live attenuated vaccines within 30 days.

    Objectives: rimary - To evaluate whether pembrolizumab, alone or given to patients receiving standard chemotherapy, improves progression free survival in malignant pleural mesothelioma (MPM) compared to standard chemotherapy. Secondary To evaluate whether pembrolizumab improves overall survival when added to standard chemotherapy; To evaluate the tolerability of pembrolizumab, alone or given to patients receiving standard chemotherapy; To assess antitumour activity of pembrolizumab, alone or given to patients receiving standard chemotherapy including response rate and overall survival; To evaluate quality of life effects of pembrolizumab, alone or given to patients receiving standard chemotherapy. Exploratory - To explore the predictive and prognostic value of PD-L1 expression and presence of T cell subsets within the tumour microenvironment and other exploratory blood based biomarkers.

    NCT Registration ID (from clinicaltrials.gov): NCT02784171
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Permanently Closed
    Activation Date: October 07, 2016 Closing Date: September 04, 2020



    		Permanently Closed
    I79

    NCIC CTG Phase I/II Study of Taxol and Ifosfamide in Advanced Non-Small Cell Lung Cancer


    NCIC CTG Phase I/II Study of Taxol and Ifosfamide in Advanced Non-Small Cell Lung Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: September 13, 1993 Closing Date: February 08, 1996



    		Permanently Closed
    I169

    A Phase II Study of SB-715992 (NSC 727990) in Previously Untreated Patients with Metastatic or Recurrent Malignant Melanoma


    A Phase II Study of SB-715992 (NSC 727990) in Previously Untreated Patients with Metastatic or Recurrent Malignant Melanoma

    Eligibility: Patients with histologically documented malignant melanoma with metastatic or recurrent disease. Unidimensionally measurable disease by RECIST criteria. Prior adjuvant immunotherapy permitted; no prior chemotherapy. Patients must be > 4 weeks since major surgery or radiation therapy, and > 3 months since prior adjuvant immunotherapy. Patients must have archival tumour specimen available for correlative study

    Objectives: To assess the efficacy and toxicity of SB-715992 given by 1 hour intravenous infusion once every 3 weeks in previously untreated patients with metastatic or recurrent malignant melanoma.

    NCT Registration ID (from clinicaltrials.gov): NCT00095953
    Participation: Participation in this phase II study is restricted to invited centres.
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: November 22, 2004 Closing Date: May 01, 2006



    		Permanently Closed
    I202

    A Randomized Phase II Study of Interleukin-21 (rIL-21) versus Dacarbazine (DTIC) in Patients with Metastatic or Recurrent Melanoma


    A Randomized Phase II Study of Interleukin-21 (rIL-21) versus Dacarbazine (DTIC) in Patients with Metastatic or Recurrent Melanoma

    Complexity Level: 2

    Eligibility: Patients with histologically documented malignant melanoma which is recurrent or metastatic and is not curable by surgical or other means. Unidimensionally measurable disease. Prior adjuvant immunotherapy permitted; no other prior immunotherapy or chemotherapy permitted, except for RAF and MEK-Inhibitors. Patients must be >4 weeks since major surgery or radiation therapy, and >1 month since prior adjuvant immunotherapy. Patients must have archival tumour tissue from their primary and/or metastatic tumour available for correlative study.

    Objectives: To compare efficacy of rIL-21 by IV bolus injection daily x 5 in weeks 1,3,and 5 every 8 weeka(Arm 1) & dacarbazine by IV injection Day 1 every 3 weeks(Arm 2)in previously untreated patients with metastatic or recurrent incurable malignant melanoma. The primary efficacy measure for this study is progression free survival. To compare the effect of rIL-21 and dacarbazine on response rate, duration of response, and overall survival. To determine the safety & toxicity profile of rIL-21 & dacarbazine. To characterize the effects of rIL-21 on lymphocyte sub-populations cell-count, dendritic cells sub-population cell counts, circulating miR-155 and soluble CD25 in blood before & after treatment as potential biomarkers for drug activity. To evaluate pre-existing & treatment induced immunogenicity of rIL-21 by measuring antibodies to rIL-21. To assess for pharmacogenomic markers of activity and toxicity. To assess pre-therapeutic markers for response & non-progression on archival specimens.

    NCT Registration ID (from clinicaltrials.gov): NCT01152788
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 28, 2010 Closing Date: February 29, 2012



    		Permanently Closed
    I137

    A Phase II Study of Flavopiridol (HMR 1275; NSC 649890) in Patients With Previously Untreated Metastatic Malignant Melanoma


    A Phase II Study of Flavopiridol (HMR 1275; NSC 649890) in Patients With Previously Untreated Metastatic Malignant Melanoma

    Eligibility: Patients with malignant melanoma, recurrent and non-curable by surgical or other means. Prior adjuvant immunotherapy permitted. No systemic therapy for relapsed disease (ie, chemotherapy naïve).

    Objectives: To determine the efficacy and toxicity of flavopiridol given as a one hour IV infusion daily x three days every three weeks in patients with recurrent/metastatic malignant melanoma.

    NCT Registration ID (from clinicaltrials.gov): NCT00005971
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 04, 2000 Closing Date: July 13, 2001



    		Permanently Closed
    I104

    NCIC CTG Randomized Phase II Study of Two Schedules of Bryostatin 1 (NSC 339555) in Patients With Advanced Malignant Melanoma


    NCIC CTG Randomized Phase II Study of Two Schedules of Bryostatin 1 (NSC 339555) in Patients With Advanced Malignant Melanoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 05, 1997 Closing Date: October 26, 1998



    		Permanently Closed
    I5

    NCIC CTG Phase II Study of Spirogermanium in Melanoma


    NCIC CTG Phase II Study of Spirogermanium in Melanoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 01, 1983 Closing Date: May 14, 1984



    		Permanently Closed
    I189

    A Phase II Study of Interleukin-21 (rIL-21) in Patients with Metastatic or Recurrent Malignant Melanoma


    A Phase II Study of Interleukin-21 (rIL-21) in Patients with Metastatic or Recurrent Malignant Melanoma

    Eligibility: Patients with histologically documented malignant melanoma with metastatic or recurrent disease. Unidimensionally measurable disease by RECIST criteria. Prior adjuvant immunotherapy permitted; no prior chemotherapy. Patients must be > 4 weeks since major surgery or radiation therapy, and > 3 months since prior adjuvant immunotherapy. Patients must have archival tumour specimen available for correlative study.

    Objectives: To assess the efficacy and toxicity of rIL-21 given by IV push for the first 5 days weeks 1, 3 and 5 at 50ug/kg/day in the first 6 previously untreated patients with metastatic or recurrent malignant melanoma. To characterize the pharmacokinetics of rIL-21 when dosed at 50 µg/kg/day. To characterize the effects of rIL-21 on lymphocyte cell-count and soluble CD25 in serum as a potential biomarkers for drug activity. To evaluate the immunogenicity of rIL-21, specifically preexisting immunogenicity to the drug and antibody induction during treatment. To assess melanoma antigenic markers for response and non progression on archival tissue from patients enrolled on the study.

    NCT Registration ID (from clinicaltrials.gov): NCT00514085
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 10, 2007 Closing Date: August 17, 2009



    		Permanently Closed
    I61

    NCIC CTG Phase II Study of 10-EDAM in Patients With Metastatic Malignant Melanoma


    NCIC CTG Phase II Study of 10-EDAM in Patients With Metastatic Malignant Melanoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 08, 1991 Closing Date: January 21, 1992



    		Permanently Closed
    I225

    A Phase II Study of the Assessment of Response to Pembrolizumab in Metastatic Melanoma: CT Texture Analysis as a Predictive Biomarker


    A Phase II Study of the Assessment of Response to Pembrolizumab in Metastatic Melanoma: CT Texture Analysis as a Predictive Biomarker

    Complexity Level: 2

    Eligibility: Histologically confirmed melanoma that is recurrent/metastatic and not amenable to potentially curative surgery. Clinically and/or radiologically documented disease. ECOG 0-1. No prior systemic therapy for metatatic melanoma. No known history of HIV. Patients with active autoimmune disease that requires systemic steroids or immunosuppressive agents are not eligible. Patients with a history of malignancy within 5 years prior to first study drug administration are not eligible. Patients with an allergy to iodinated contrast media used for CT and patients with known history of active TB are not eligible.

    Objectives: Primary Objective: to determine if tumour texture measures derived from CT correlates with response. Secondary Objectives: to determine if tumour texture measures derived from CT correlated with time to disease progression; to assess duration of response; to assess overall response rate; to assess overall survival; to compare QALY between pembrolizumab and dacarbazine; to compare QALY between pembrolizumab and ipilimumab; toxicity using CTCAE v4.

    NCT Registration ID (from clinicaltrials.gov): NCT02740920
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Permanently Closed
    Activation Date: May 12, 2016 Closing Date: March 12, 2018



    		Permanently Closed
    I91

    NCIC CTG Phase I/II Study of BB2516 in Patients with Malignant Melanoma and Cutaneous Metastases


    NCIC CTG Phase I/II Study of BB2516 in Patients with Malignant Melanoma and Cutaneous Metastases

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 01, 1995 Closing Date: March 31, 1997



    		Permanently Closed
    I21

    NCIC CTG Phase II Study of Menogaril in Melanoma


    NCIC CTG Phase II Study of Menogaril in Melanoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: May 30, 1985 Closing Date: March 15, 1986



    		Permanently Closed
    I14

    NCIC CTG Phase II Study of N-methylformamide in Melanoma


    NCIC CTG Phase II Study of N-methylformamide in Melanoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: December 01, 1984 Closing Date: April 29, 1985



    		Permanently Closed
    I224

    A Phase II Study of Concurrent Dabrafenib and Trametinib with Stereotactic Radiation in the Management of Patients with BRAF Mutation-Positive Malignant Melanoma and Brain Metastases


    A Phase II Study of Concurrent Dabrafenib and Trametinib with Stereotactic Radiation in the Management of Patients with BRAF Mutation-Positive Malignant Melanoma and Brain Metastases

    Complexity Level: 2

    Eligibility: Histologically confirmed melanoma metastatic to brain and determined to be BRAF V600 mutation-positive. Presence of measurable disease (with at least one measurable CNS lesion per RECIST 1.1). Presence of 1-10 brain metastases as confirmed on a thin slice axial T1 post-gadolinium MRI sequence. Maximum diameter of a single brain lesion should be <=4 cm. All CNS metastases amenable to single fraction SRS and/or fractionated SRS. ECOG 0-1. No prior treatment with a BRAF inhibitor or MEK inhibitor. No history of malignancy with confirmed activating RAS mutation at any time. No history of HEP B or HEP C virus and no history of interstitial lung disease or active pneumonitis. No prior whole brain radiation or brainstem metastases. No contraindications to MRI and/or Gadolinium contrast or stereotactic brain radiation therapy. No history or current evidence/risk of retinal vein occlusion or central serous retinopathy.

    Objectives: Primary Objective: To determine intracranial objective response rate; Secondary objectives: extra-cranial objective response rate and overall ORR; duration of response; intracranial and overall progression free survival; overall survival and to evaluate the safety and tolerability of the regimen using CTCAE v. 4.

    NCT Registration ID (from clinicaltrials.gov): NCT02974803
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: CCTG Led Trial
    Status: Permanently Closed
    Activation Date: November 23, 2016 Closing Date: April 24, 2019



    		Permanently Closed
    I156

    A Phase II Study of Perifosine in Previously Untreated Patients With Metastatic or Recurrent Malignant Melanoma


    A Phase II Study of Perifosine in Previously Untreated Patients With Metastatic or Recurrent Malignant Melanoma

    Eligibility: Patients with histologically documented malignant melanoma, with metastatic or recurrent disease not curable by other means. Patients may have had prior adjuvant immunotherapy but must NOT have received ANY prior chemotherapy. Disease must be clinically and/or radiologically documented and at least one site of disease must be unidimensionally measurable.

    Objectives: To assess the efficacy and toxicity of Perifosine given by mouth for 3 weeks every 4 weeks in previously untreated patients with metastatic or recurrent malignant melanoma.

    NCT Registration ID (from clinicaltrials.gov): NCT00053781
    Participation: Limited to invited centres only.
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: May 16, 2003 Closing Date: April 26, 2004



    		Permanently Closed
    I56

    NCIC CTG Phase II Study of DuP937 in Patients With Melanoma


    NCIC CTG Phase II Study of DuP937 in Patients With Melanoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: March 07, 1991 Closing Date: April 23, 1992



    		Permanently Closed
    I34

    NCIC CTG Phase I Study of Levamisole/Interferon in Melanoma


    NCIC CTG Phase I Study of Levamisole/Interferon in Melanoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: November 13, 1986 Closing Date: May 07, 1987



    		Permanently Closed
    I87

    A Phase IB Biomodulation Study of Increasing Doses of Weekly Levamisole in the Adjuvant Treatment of Patients With Moderate/High Risk, Localized, Resected Cutaneous Malignant Melanoma


    A Phase IB Biomodulation Study of Increasing Doses of Weekly Levamisole in the Adjuvant Treatment of Patients With Moderate/High Risk, Localized, Resected Cutaneous Malignant Melanoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 26, 1995 Closing Date: May 01, 1997



    		Permanently Closed
    I26

    NCIC CTG Phase II Study of Trimetrexate in Melanoma


    NCIC CTG Phase II Study of Trimetrexate in Melanoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 28, 1986 Closing Date: November 06, 1987



    		Permanently Closed
    I243

    A Phase II Study of RP-6306 in Patients with Advanced Cancer

    The purpose of this study is to test the effects of RP-3606 when given with standard treatment in different types of cancer and to determine if specific biomarkers have an improved response to treatment comparted to those with the biomarker.

    A Phase II Study of RP-6306 in Patients with Advanced Cancer

    Complexity Level: 1

    Eligibility: Patients (>=18yrs old, ECOG PS0-1), life expectancy >=3 mo., must have advanced/metastatic/recurrent or unresectable cancer, with no curable therapy. All reversible prior toxicity related to prior therapies must have recovered to grade =<1 and have adequate washout. Measurable disease per RECIST 1.1. Consent to release of tissue block and biopsies. Women/men of childbearing potential must have agreed to use an effective contraceptive method. No history of other malignancies or uncontrolled /serious illnesses which would not permit the patient to be managed per protocol. Hypersensitivity to any of the study drug components. No CNS metastases. No pts who are unable to swallow oral meds/have impairment of GI function. No history of non-compliance. Met additional cohort specific eligibility criteria.

    Objectives: Primary: To determine the response rate of RP-6306 in patients with selected cancers receiving standard agents. Secondary: To determine the safety and tolerability of RP-6306 in patients with selected cancers receiving standard agents; To explore the recommended dose of RP-6306, if indicated. Tertiary: To assess potential biomarkers of response, including but not limited to such as PP2R1A, FBXW7 mutations or CCNE1 amplification / overexpression; To assess efficacy of RP-6306 + FOLFIRI in patients harboring KRAS/TP53/FBXW7 triple mutation; To correlate changes in ctDNA with response.clinical outcomes; To summarize progression-free survival.

    NCT Registration ID (from clinicaltrials.gov): NCT05605509
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Open to Accrual
    Activation Date: April 17, 2023



    		Open to Accrual
    I238B

    A Phase II Study of Durvalumab Substudy B: For Continued Treatment (+/-) Tremelimumab) of Patients Previously Enrolled to Completed CCTG Studies

    The purpose of this substudy is to allow continued treatmet on IO (durvalumab (+/- tremelimumab) or any other anti PD-1/PD-L1 agents +/- anti CTLA agents on CCTG trials that are closed. Also monitor side effects.

    A Phase II Study of Durvalumab Substudy B: For Continued Treatment (+/-) Tremelimumab) of Patients Previously Enrolled to Completed CCTG Studies

    Complexity Level: 1

    Eligibility: Patients must be currently enrolled and receiving active treatment on a treatment arm containing durvalumab +/- tremelimumab with or without maintenance pemetrexed with no contraindications to continue receiving their current study regimen. Must also meet criteria for continued treatment based on the current product monograph in Canada for the applicable agent(s) being received. For BR.34 ONLY: patients who have disease progression (iUPD) on durvalumab may receive one dose of tremelimumab (75 mg) along with their next durvalumab infusion as long as all the following criteria are met: • Patient is clinically stable • According to the judgement of the treating physician, the patient had clinical benefit while receiving tremelimumab in the induction phase on BR.34 • ECOG performance status of 0 or 1 and specified lab values per B2.1.3 section of protocol.

    Objectives: To facilitate continued treatment with durvalumab (+/- tremelimumab) for patients currently enrolled on completed CCTG trials. • To monitor safety and tolerability.

    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Open to Accrual
    Activation Date: April 14, 2022



    		Open to Accrual
    I238

    A Phase II Study of Durvalumab Substudy A: In Patients who Discontinued Prior Checkpoint Therapy Due to Immune Related Toxicity Substudy B: For Continued Treatment (+/-) Tremelimumab) of Patients Previously Enrolled to Completed CCTG Studies

    The purpose of this study is to determine if patients who discontinued immunotherapy due to severe side effects related to treatment can be safely retreated with durvalumab and to investigate whether prophylactic steroid use can prevent or reduce new or recurrent side effects. This study will also examine response, progression free survival and explore the relationship between certain biomarkers and outcomes of treatment.

    A Phase II Study of Durvalumab Substudy A: In Patients who Discontinued Prior Checkpoint Therapy Due to Immune Related Toxicity Substudy B: For Continued Treatment (+/-) Tremelimumab) of Patients Previously Enrolled to Completed CCTG Studies

    Complexity Level: 1

    Eligibility: Must live in Canada & received durvalumab +/- tremelimumab, with or without chemo/targeted therapy. Patients who received other PD-1/PD-L1 agents +/- anti-CTLA agents may be eligible, contact CCTG. Had a G3 irAEs that required study drug discontinuation per protocol, selected G4 irAEs, & prolonged G1-2 irAEs where physician/patient wanted to discontinue therapy due to poor tolerability. irAE must have resolved to <= grade 1 or baseline. Completed steroid therapy & have documented CR, PR, or prolonged SD to initial IO therapy. Prior adjuvant/neoadjuvant/consolidation IO is eligible provided a >= 6 mo. treatment free interval prior to enrollment and >= 1 standard of care chemo in the palliative setting (discuss with CCTG if chemo is not SOC or indicated or patient refusal/not eligible). Ineligible if prior G4 non-hematological, non-endocrine irAE, or if required biologic agents to manage irAE, had PD as best response to initial IO, or symptomatic or uncontrolled brain mets.

    Objectives: Primary: To determine the safety and toxicity profile of rechallenging with durvalumab in patients who previously discontinued immunotherapy due to irAE. Secondary: To determine the objective response rate (RECIST 1.1 and iRECIST); To evaluate the efficacy of corticosteroids in preventing recurrent or new grade 2 or higher irAEs. Tertiary: To explore PFS and iPFS on rechallenge with durvalumab after progression on initial immunotherapy; To explore blood-based and stool-based biomarkers for irAEs; PD-L1 expression.

    NCT Registration ID (from clinicaltrials.gov): NCT03847649
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Open to Accrual
    Activation Date: June 07, 2019



    		Open to Accrual
    I228

    A Phase II Study of Durvalumab and Tremelimumab in Patients with Advanced Rare Tumours


    A Phase II Study of Durvalumab and Tremelimumab in Patients with Advanced Rare Tumours

    Complexity Level: 2

    Eligibility: Clinically and/or radiologically documented disease, with at least one measurable lesion as defined by RECIST 1.1; >=16 years of age; ECOG 0 or 1; no limit on number of prior chemo; No therapy with PD-1/PD-L1 or CTLA-4 inhibitors. No prior autoimmune or inflammatory disorders ie inflammatory bowel disease, diverticulitis with the exception of diverticulosis, celiac disease or other serious gastrointestinal chronic conditions associated with diarrhea), systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome , etc., within the past 3 years prior to the start of treatment. No history of primary immunodeficiency, allogenic organ transplant that requires therapeutic use of IO agents within 28 days. No attenuated vaccination administered within 30 days. No untreated symptomatic brain mets or in whom radiation or surgery is indicated. NO pts with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol.

    Objectives: To evaluate the objective response rate of the combination of durvalumab and tremelimumab given by IV every 4 weeks in patients with rare tumours. To explore the correlation between anti-tumour activity and PD-L1 expression, presence of tumour infiltrating lymphocytes (TILs) and T cell subsets within the tumour. To explore the correlation between anti-tumour activity and genomic alterations in tumour. To assess the consistency of histopathological diagnosis of rare tumours through central review of pathology specimens. To explore the correlation between anti-tumour activity and toxicity with blood based biomarkers. To evaluate the tolerability and safety of durvalumab and tremelimumab combination. To evaluate the effect of durvalumab and tremelimumab combination including time to progression, progression free survival and response duration.

    NCT Registration ID (from clinicaltrials.gov): NCT02879162
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Closed to Accrual
    Activation Date: October 19, 2016 Closing Date: January 21, 2020



    		Closed to Accrual
    I226

    A Phase IB Study of Durvalumab (MEDI4736) With or Without Tremelimumab in Patients With Advanced Incurable Solid Malignancies Given with or without Standard Chemotherapy Regimens


    A Phase IB Study of Durvalumab (MEDI4736) With or Without Tremelimumab in Patients With Advanced Incurable Solid Malignancies Given with or without Standard Chemotherapy Regimens

    Complexity Level: 1

    NCT Registration ID (from clinicaltrials.gov): NCT02537418
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Closed to Accrual
    Activation Date: October 01, 2015 Closing Date: September 06, 2017



    		Closed to Accrual
    I206

    A Phase II Study of Sunitinib or Temsirolimus in Patients with Advanced Rare Tumours.


    A Phase II Study of Sunitinib or Temsirolimus in Patients with Advanced Rare Tumours.

    Complexity Level: 2

    Eligibility: Patients with recurrent, unresectable, locally advanced or metastatic rare tumours: vascular sarcomas (non-pediatric); clear cell carcinomas of ovary, endometrium; medullary thyroid carcinoma; non-pancreatic neuroendocrine tumours: pheochromocytoma, paragangliomas; adrenocortical carcinoma; thymic carcinoma; fibrolamellar hepatocellular carcinoma; rare tumours with somatic mutations in VEGFR, PDGFR, KIT, RET; rare tumours arising from known/suspected germline mutations in PTEN, TS, LKB1, NF1/2. Unidimensionally measurable disease. Archival tissue or fresh biopsy required at study entry. No limit on prior chemotherapy or radiation therapy, although no prior treatment with mTOR inhibitor (for temsirolimus) or VEGFR, PDGFR, RET or KIT inhibitor (for sunitinib) permitted. No uncontrolled hypertension, therapeutic doses of coumadin-derivative anticoagulants, or certain CYP3A4 inhibitors/inducers permitted on sunitinib arm.

    Objectives: To assess the efficacy (objective response rate) of sunitinib given orally daily for 4 weeks every 6 weeks and temsirolimus given IV weekly in patients with metastatic and/or locally advanced recurrent rare tumours. To assess the adverse events, time to progression and response duration of sunitinib orally and temsirolimus given IV weekly in patients with rare tumours. To assess time to first and second progression for patients who receive sunitinib and temsirolimus in sequence. To explore the relationship between genetic alterations in the genome in archival and/or fresh tumour tissue and blood samples from patients on this trial and their objective response to therapy. To assess the consistency of diagnosis of rare tumours through central review of pathology specimens.

    NCT Registration ID (from clinicaltrials.gov): NCT01396408
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Closed to Accrual
    Activation Date: July 14, 2011 Closing Date: February 05, 2015



    		Closed to Accrual
    I214

    A Phase I/II Study of MG1 Maraba/MAGE-A3 (MG1MA3), With and Without Adenovirus Vaccine, With Transgenic MAGE-A3 Insertion (AdMA3) in Patients with Incurable Advanced/Metastatic MAGE-A3-Expressing Solid Tumours


    A Phase I/II Study of MG1 Maraba/MAGE-A3 (MG1MA3), With and Without Adenovirus Vaccine, With Transgenic MAGE-A3 Insertion (AdMA3) in Patients with Incurable Advanced/Metastatic MAGE-A3-Expressing Solid Tumours

    Complexity Level: 1

    Eligibility: Patients with histologically confirmed, unresectable locally advanced/metastatic solid tumour (Phase I - Esophogeal/GEJ/gastric, NSCLC and breast, fallopian tube, bladder, adenocystic, anal, melanoma, periampullary, renal, liver, vulvar and ovarian). Tumour must be MAGE-A3 positive. Patient must have have at least one additional tumour mass amenable to core or excisional biopsy and must consent and be willing to undergo at least 2 core biopsies. Patients must have had a least one prior standard first line therapy for advanced/metastatic disease with adequate wash-out period since last dose. Patients must have measurable disease per RECIST 1.1 and adequate organ function. At least 4 weeks since major surgery or radiation therapy. ECOG 0-1. Age >= 18 years.

    Objectives: Phase I-To determine the recommended phase II dose/schedule and maximum tolerated dose of MG1MA3 alone, AdMA3 alone and in combination. To determine the safety, tolerability, pharmacokinetics (PK) including viral shedding, viral delivery and replication in the tumour cells and anti-tumour activity. Phase II-To assess the anti-tumour activity as evidenced by response rates and further explore the safety profile, PK, cellular and immune response, changes in tumour biomarkers and evaluate overall survival, time to progression by tumour type.

    NCT Registration ID (from clinicaltrials.gov): NCT02285816
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Closed to Accrual
    Activation Date: October 31, 2014 Closing Date: April 11, 2019



    		Closed to Accrual
    I181

    NCIC CTG Phase I Study Of AT9283 Given As A 24 Hour Infusion On Days 1 And 8 Every Three Weeks In Patients With Advanced Incurable Malignancy


    NCIC CTG Phase I Study Of AT9283 Given As A 24 Hour Infusion On Days 1 And 8 Every Three Weeks In Patients With Advanced Incurable Malignancy

    Eligibility: Advanced and/or metastatic solid tumours; non-Hodgkin's lymphoma judged to be refractory to standard therapies. Up to two prior chemotherapy regimens for metastatic disease permitted in patients with solid tumours; no chemotherapy limitations for non-Hodgkin's lymphoma patients.

    Objectives: To determine the maximum tolerated dose (MTD) and define a recommended phase II dose of AT9283 when given as a 24 hour infusion on Days 1 and 8 every three weeks in patients with advanced incurable malignancy.

    NCT Registration ID (from clinicaltrials.gov): NCT00443976
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 04, 2007 Closing Date: November 24, 2009



    		Permanently Closed
    I144

    A Phase I Study of Oral LY293111 Given Daily in Combination With Irinotecan in Patients With Solid Tumours


    A Phase I Study of Oral LY293111 Given Daily in Combination With Irinotecan in Patients With Solid Tumours

    Eligibility: Histologically or cytologically documented evidence of advanced and/or metastatic solid tumours with up to two prior chemotherapy regimens.

    Objectives: To determine the maximum tolerated dose (MTD) and recommended phase II dose of the combination of irinotecan and LY293111 when IV irinotecan is given on day 1 every 3 weeks and LY293111 is given orally twice daily from the evening of day 2 onward. To determine the toxic effects of this combination and define the duration and reversibility of these effects. To determine the pharmacokinetics of drug-drug interaction of this combination and to assess the clinical response rates in patients with measurable disease treated with this combination.

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: March 23, 2001 Closing Date: June 29, 2004



    		Permanently Closed
    I235 (CRI-CCTG-0001)

    A Phase II Open Label, Randomized Non-Comparative Trial of Nivolumab Alone or in Combination with Ipilimumab for the Treatment of Patients with Advanced Hypermutated Solid Tumors Detected by a Blood Based Assay


    A Phase II Open Label, Randomized Non-Comparative Trial of Nivolumab Alone or in Combination with Ipilimumab for the Treatment of Patients with Advanced Hypermutated Solid Tumors Detected by a Blood Based Assay

    Complexity Level: 2

    Eligibility: Histologically confirmed advanced metastatic or unresectable solid tumors with POLE/POLD1 mutations. Available tissue block from primary or metastatic tumor. Measurable disease per RECIST 1.1. Received at least 1 standard cancer therapy for their tumour type and progressed on most recent regimen. Adjuvant/neoadjuvant therapy is considered a prior therapy if recurrence within 1 year. Can be treatment naiive if patient has refused standard treatment or there is no standard treatment for their cancer. No prior immunotherapy. No primary CNS tumors. No prior autoimmune or inflammatory disorders within the past 3 years. No history of primary immunodeficiency, allogeneic organ transplant that requires therapeutic use of IO agents within 14 days. No hypersensitivity to nivolumab or ipilimumab or any excipient. No active brain metastases or leptomeningeal metastases. No serious illnesses or medical conditions which would not permit the patient to be managed per protocol.

    Objectives: Primary - Objective response rate by RECIST 1.1 of nivolumab alone and of nivolumab combined with ipilimumab in randomized patients with advanced solid tumors with detectable POLE or POLD1 mutations as determined by cfDNA. Secondary - Evaluate objective response rate of nivolumab alone and nivolumab in combination with ipilimumab in all treated patients with detectable POL mutations in either blood or tissue. Evaluate duration of response. Assess safety and characterize toxicities of nivolumab combined with ipilimumab and nivolumab alone. Assess the correlation between POLE/POLD1 mutations in tumor and POLE/POLD1 mutations in blood. Evaluate response by iRECIST. Exploratory - Determine Progression Free Survival and Overall Survival. Determine correlation between POLE/POLD1 mutations occurring within or outside of the exonuclease domain and tumor mutation load by whole exome and RNA sequencing. Determine correlation between tumour mutation burden in cfDNA and tumor tissue.

    NCT Registration ID (from clinicaltrials.gov): NCT03461952
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Permanently Closed
    Activation Date: August 28, 2018 Closing Date: August 02, 2019



    		Permanently Closed
    I96

    NCIC CTG Phase I Study of JM216 Plus VP16(Etoposide)


    NCIC CTG Phase I Study of JM216 Plus VP16(Etoposide)

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 15, 1996 Closing Date: June 03, 1999



    		Permanently Closed
    I44

    NCIC CTG Phase I Study of CI-937 Given Weekly x 3 Every 5 Weeks


    NCIC CTG Phase I Study of CI-937 Given Weekly x 3 Every 5 Weeks

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 18, 1988 Closing Date: March 11, 1991



    		Permanently Closed
    I130

    A Phase I Study of T900607 Given Once Every Three Weeks in Patients With Advanced Refractory Cancer


    A Phase I Study of T900607 Given Once Every Three Weeks in Patients With Advanced Refractory Cancer

    Eligibility: Patients with advanced refractory cancer. Unidimensionally measurable disease. Prior chemotherapy radiation (< 25 % hematopoietic bone marrow), immunotherapy and surgery permitted.

    Objectives: To determine the maximum tolerated dose (MTD) and recommended phase II dose of T900607 when given as a 60 minute infusion every 21 days. To evaluate the safety and dose-limiting toxicities (DLT), determine the pharmacokinetics parameters and pharmacodynamic effects. Document preliminary efficacy information and correlate expression of drug resistance markers with response.

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 07, 2000 Closing Date: December 19, 2002



    		Permanently Closed
    I218

    A Study of Vinblastine and Temsirolimus in Pediatric Patients with Recurrent or Refractory Lymphoma or Solid Tumours Including CNS Tumours


    A Study of Vinblastine and Temsirolimus in Pediatric Patients with Recurrent or Refractory Lymphoma or Solid Tumours Including CNS Tumours

    Complexity Level: 1

    Eligibility: Pediatric patients (age >= 1 year and <=18 years) with histologically confirmed, relapsed/refractory solid tumour, CNS/localized brainstem tumour or Lymphoma (Phase II - low-grade glioma). Patients must have had a least one prior treatment regimen and have adequate washout. Prior therapy with vinblastine and mTOR inhibitors (e.g. temsirolimus or sirolimus) permitted. Prior surgery and radiation permitted provided adequate time has elapsed form last dose. Adequate organ function. No untreated brain metastases, untreated spinal cord compression or meningeal metastases for patients with lymphoma or solid tumours except primary CNS tumours.

    Objectives: PRIMARY - To determine the recommended phase II dose (RP2D) of the combination of vinblastine and temsirolimus (administered as a weekly intravenous dose) in children with recurrent or refractory solid tumours including central nervous system (CNS) tumours and lymphoma and to describe the associated toxicities in children. SECONDARY - (1) To assess the anti-tumour activity of vinblastine in combination with temsirolimus in pediatric solid tumours; (2) To characterize the pharmacokinetics of temsirolimus in whole blood (including its principal metabolite sirolimus) when administered in combination with vinblastine; (3) To assess the pharmacodynamics of this regimen by evaluating change in plasma cytokines and angiogenic factors (CAF) and mTOR inhibition in peripheral mononuclear cells as a biomarker of target inhibition.

    NCT Registration ID (from clinicaltrials.gov): NCT02343718
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Permanently Closed
    Activation Date: June 02, 2015 Closing Date: March 31, 2017



    		Permanently Closed
    I115

    A Phase I Study of Aplidine Given as a 1 Hour IV Infusion Daily x 5 Days Every 3 Weeks in Patients with Solid Tumours or Low or Intermediate Grade Non-Hodgkin's Lymphoma Refractory to Standard Curative Therapy


    A Phase I Study of Aplidine Given as a 1 Hour IV Infusion Daily x 5 Days Every 3 Weeks in Patients with Solid Tumours or Low or Intermediate Grade Non-Hodgkin's Lymphoma Refractory to Standard Curative Therapy

    Eligibility: Histologically or cytologically documented advanced and/or metastatic solid tumours or refractory low/intermediate grade NHL. Prior chemotherapy and radiotherapy permitted. No patients with pre-existing neuropathies permitted.

    Objectives: To determine the maximum tolerated dose (MTD) of aplidine given as a 1 hour infusion daily x 5 every 3 weeks. To determine safety, toxicity profile and pharmacokinetics of aplidine given in this schedule. To examine efficacy of aplidine given in this schedule.

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: February 15, 1999 Closing Date: February 07, 2002



    		Permanently Closed
    I217 (TOPAZ)

    A Phase I and Enrichment Study of Low-Dose Metronomic Topotecan and Pazopanib in Pediatric Patients with Recurrent or Refractory Solid Tumours.


    A Phase I and Enrichment Study of Low-Dose Metronomic Topotecan and Pazopanib in Pediatric Patients with Recurrent or Refractory Solid Tumours.

    Complexity Level: 1

    Eligibility: Part 1: Patients must have recurrent or refractory solid tumours, excluding CNS tumours tumours. Part 2: Patients must have neuroblastoma or rhabdomyosarcoma. All patients must have histologic verification of malignancy, adequate bone marrow, renal, cardiac and liver function, measurable or evaluable disease and must meet all other eligibility criteria as defined in Protocol Section 4.

    Objectives: Primary Objective: To determine the recommended phase II dose and maximum tolerated dose of LDM topotecan in combination with pazopanib. Secondary Objectives: Anti-tumour activity in solid tumours and specifically in neuroblastoma and rhabdomyosarcoma. Characterize the pharmacokinetic profile as well as drug-drug interactions, and assess the anti-angiogenic activity.

    NCT Registration ID (from clinicaltrials.gov): NCT02303028
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Permanently Closed
    Activation Date: November 03, 2014 Closing Date: April 18, 2019



    		Permanently Closed
    I166B

    This is a Multi-Centre, Open-Label, Dose-Escalating Phase I Clinical Trial of AEG35156 in Combination With Docetaxel in Patients With Solid Tumours


    This is a Multi-Centre, Open-Label, Dose-Escalating Phase I Clinical Trial of AEG35156 in Combination With Docetaxel in Patients With Solid Tumours

    Eligibility: Patients with histologically documented solid tumours, with locally advanced, metastatic or recurrent disease for which single agent docetaxel therapy is a reasonable therapeutic option. Presence of clinically and/or radiologically documented disease. ECOG performance status 0, 1 or 2. Prior chemotherapy (up to two prior regimens for metastatic/recurrent disease, and one regimen for adjuvant treatment, but no more than one taxane-containing regimen) is permitted. Prior surgery, hormone therapy, immunotherapy and radiation therapy are permitted.

    Objectives: To determine the maximum tolerated dose (MTD) and define a recommended phase II dose of AEG35156 administered intravenously in combination with docetaxel.

    NCT Registration ID (from clinicaltrials.gov): NCT00372736
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 20, 2006 Closing Date: March 20, 2008



    		Permanently Closed
    I103

    NCIC CTG Phase I Study of BCH-4556 Given as a 30 Minute Infusion Every 3 Weeks


    NCIC CTG Phase I Study of BCH-4556 Given as a 30 Minute Infusion Every 3 Weeks

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 27, 1997 Closing Date: March 02, 1999



    		Permanently Closed
    I125

    A Phase I Study Of MG98 Given as a 2 Hour Twice Weekly IV Infusion in Patients With Advanced Cancer


    A Phase I Study Of MG98 Given as a 2 Hour Twice Weekly IV Infusion in Patients With Advanced Cancer

    NCT Registration ID (from clinicaltrials.gov): NCT00003890
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: February 22, 1999 Closing Date: March 08, 2001



    		Permanently Closed
    I43

    NCIC CTG Phase I Study of CI-937 Bolus q 3 to 4 wks


    NCIC CTG Phase I Study of CI-937 Bolus q 3 to 4 wks

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 19, 1988 Closing Date: August 10, 1990



    		Permanently Closed
    I154

    A Phase I Study of a Second Generation Clusterin Antisense Oligonucleotide (OGX-011) in Combination With Docetaxel


    A Phase I Study of a Second Generation Clusterin Antisense Oligonucleotide (OGX-011) in Combination With Docetaxel

    Eligibility: Histologic or cytologic evidence of a solid tumour that has been shown to overexpress clusterin (prostate, renal cell, bladder, breast, ovarian cancers). Must have metastatic or locally recurrent disease that is either refractory to standard curative therapy or for which no curative therapy exists. No limit to the number of previous chemotherapy, hormone therapy for patients enrolled to schedule 'A' but limit of <= 2 prior regimens if registered to schedule 'B'.

    Objectives: To determine the toxicity and define the recommended phase II dose of OGX-011 when given in combination with docetaxel. To determine the pharmacokinetic profile of OGX-011 and weekly docetaxel when administered in combination. To measure evidence of effect on serum clusterin levels and clusterin expression in PBMC and accessible tumours. To document any objective responses.

    NCT Registration ID (from clinicaltrials.gov): NCT00471432
    Participation: Limited to invited centres only.
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: March 06, 2003 Closing Date: June 28, 2005



    		Permanently Closed
    I179

    Phase I Study Of CCI-779 In Combination With Carboplatin And Paclitaxel In Patients With Advanced Solid Tumours.


    Phase I Study Of CCI-779 In Combination With Carboplatin And Paclitaxel In Patients With Advanced Solid Tumours.

    Eligibility: Patients with histological confirmed advanced solid tumours for which therapy with carboplatin and paclitaxel is a reasonable therapeutic option (at expanded cohort at recommended dose: endometrial cancer or ovarian cancer patients only). Measurable or non-measurable disease (except in expanded cohort at recommended dose: all patients must have measurable disease).

    Objectives: To establish the maximum tolerated dose (MTD) and recommended phase II dose (RPTD) of CCI 779 in combination with carboplatin and paclitaxel, administered intravenously on day 1 of a three week cycle, in patients with advanced solid cancers. To describe the frequency and severity of toxic effects of the combination of carboplatin, paclitaxel and CCI-779 given at the recommended dose and schedule. To document any evidence of objective antitumour activity of the combination of CCI-779 with carboplatin and paclitaxel, in those patients with measurable disease. To determine the pharmacokinetic profile of carboplatin, paclitaxel alone and with CCI-779 co-administration within patients, and to determine the pharamacokinetic profile of CCI-779 alone and with carboplatin and paclitaxel co-administration within the same patients.

    NCT Registration ID (from clinicaltrials.gov): NCT00408655
    Participation: Limited to invited centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: October 25, 2006 Closing Date: March 27, 2009



    		Permanently Closed
    I67

    NCIC CTG Phase I Study Of Fostriecin Given as an Intravenous Bolus Daily for 5 Consecutive Days


    NCIC CTG Phase I Study Of Fostriecin Given as an Intravenous Bolus Daily for 5 Consecutive Days

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: September 10, 1992 Closing Date: May 21, 1996



    		Permanently Closed
    I36

    NCIC CTG Phase I Study of Didemnin-B Weekly x 4 q 6 wks


    NCIC CTG Phase I Study of Didemnin-B Weekly x 4 q 6 wks

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: November 01, 1986 Closing Date: November 29, 1991



    		Permanently Closed
    I85

    A Phase I Study of BMS-182751 (JM-216) and Etoposide in Patients With Previously Untreated Cancer


    A Phase I Study of BMS-182751 (JM-216) and Etoposide in Patients With Previously Untreated Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 22, 1994 Closing Date: November 08, 1994



    		Permanently Closed
    I231

    A Phase I Study of CX5461


    A Phase I Study of CX5461

    Complexity Level: 1

    Eligibility: All patients: Age >=18 years. ECOG 0, 1, or 2. Must have an available tissue block. Adequate organ function. Patients must not have known photosensitivity disorders, and must agree to use adequate sun protection and avoid tanning booths. No active infections or untreated/uncontrolled cardiovascular conditions. Phase I: Patients with histologically and/or cytologically confirmed solid malignancy. No limit to the number of prior cytotoxic or other systemic therapy regimens. Phase II: Patients must have triple negative breast cancer or must have BRCA1/2 or HRD germline or somatic aberrations (known, or documented during pre-enrolment screening). Must provide consent for a whole blood sample. At least 6 patients in each cohort must provide consent for a tumour and skin biopsy prior to and on treatment. Must have received at least one but no more than 3 prior cytotoxic therapy regimens. No limit to the number of prior other systemic therapy regimens, but prior PARP inhibtors not allowed.

    Objectives: Phase I: Primary - To determine the recommended phase II dose (RP2D) and schedule of CX5461 in patients with solid tumours. Secondary - To establish the safety and tolerability of CX5461 given intravenously to patients with solid tumours; To determine the pharmacokinetics of CX5461 given intravenously in patients with solid tumours. Exploratory - To explore the relationship between germline HRD aberrations and outcomes of CX5461. Phase II: Primary - To evaluate anti-tumour activity assessed by response rate (RR) in each cohort. Secondary - To estimate the progression free survival (PFS) rate at 6 months in each cohort; To assess the safety and toxicity profile of CX5461. Exploratory - To evaluate predictive biomarkers of response to CX5461; To evaluate pharmacodynamic biomarkers of response to CX5461 using ctDNA (all patients) and paired biopsies (selected patients); To explore the relationship between germline HRD aberrations and outcomes of CX5461.

    NCT Registration ID (from clinicaltrials.gov): NCT02719977
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Permanently Closed
    Activation Date: May 16, 2016 Closing Date: November 25, 2019



    		Permanently Closed
    I133

    A Phase I Study of NX211 in Combination With Cisplatin Given as an IV Infusion Days 1, 2 & 3 Every 3 Weeks in Patients With Solid Tumours


    A Phase I Study of NX211 in Combination With Cisplatin Given as an IV Infusion Days 1, 2 & 3 Every 3 Weeks in Patients With Solid Tumours

    Eligibility: Histologically or cytologically documented advanced and/or metastatic solid tumours with 1 or less prior chemotherapy regimens.

    Objectives: To determine the maximum tolerated dose (MTD) and recommended phase II dose of NX211 given in combination with cisplatin on days 1, 2 and 3 every 3 weeks. To describe the toxicity profile, dose limiting toxicities and the pharmacokinetics of NX211 and cisplatin when given in this schedule. The correlation, if any, between the toxicity profile and the pharmacokinetics will be determined. Objective tumour response will be assessed in those patients with measurable disease in particular for the patients with small cell lung cancer entered at the level of MTD.

    NCT Registration ID (from clinicaltrials.gov): NCT00006036
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: March 22, 2000 Closing Date: November 22, 2001



    		Permanently Closed
    I107

    NCIC CTG Phase I Study of BAY 12-9566 in Patients With Advanced Cancer


    NCIC CTG Phase I Study of BAY 12-9566 in Patients With Advanced Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 27, 1997 Closing Date: December 10, 1997



    		Permanently Closed
    I32

    NCIC CTG Phase I Study of Trimetrexate Glucuronate Daily x 9 Bolus


    NCIC CTG Phase I Study of Trimetrexate Glucuronate Daily x 9 Bolus

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 01, 1985 Closing Date: December 01, 1985



    		Permanently Closed
    I177

    A Phase I Study Of AT7519M Given Twice Weekly In Patients With Advanced Incurable Malignancy


    A Phase I Study Of AT7519M Given Twice Weekly In Patients With Advanced Incurable Malignancy

    Complexity Level: 1

    Eligibility: Advanced/metastatic solid tumour or non-Hodgkins lymphoma. Patients with solid tumours may not have had more than 2 prior regimens for metastatic disease; patients with non-Hodgkins lymphoma must have, in the opinion of the investigator, failed all standard therapies.

    Objectives: To determine the safety, tolerability, toxicity profile and define a recommended phase II dose of AT7519M given as a one hour infusion twice weekly for two weeks every 21 days in patients with advanced incurable malignancy.

    NCT Registration ID (from clinicaltrials.gov): NCT00390117
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 22, 2006 Closing Date: April 04, 2011



    		Permanently Closed
    I188

    A Phase I Clinical And Pharmacokinetic Study Of SB939 In Patients With Advanced Cancer


    A Phase I Clinical And Pharmacokinetic Study Of SB939 In Patients With Advanced Cancer

    Eligibility: Patients with histologically or cytologically confirmed, locally advanced or metastatic solid tumours, refractory to standard therapy or for which conventional therapy is not effective. No anti-cancer treatment <= 28 days. ECOG 0, 1 or 2. Adequate cardiac function and acceptable end-organ function. No pre-exisitng peripheral neuropathy >= gr 2.

    Objectives: 1.1 The primary objective of this study is to determine the recommended phase II dose of oral SB939 in patients with solid tumours. SB939 will be administered initially for 3 consecutive days every other week and then for 5 consecutive days every other week at escalating doses. 1.2 To determine the toxic effects of SB939 given in this schedule, their association with dose and pharmacokinetics 1.3 To assess the pharmacokinetic profile of SB939 given in this schedule 1.4 To assess preliminary evidence of anti-tumour effects in patients with measurable disease by documentation of objective response 1.5 To establish proof-of-principle for SB939 effects on histone acetylation by evaluation of histone acetylation and other biomarkers in peripheral blood mononuclear cells (PBMCs) at all dose levels and in tumour tissue at the recommended phase II dose level

    NCT Registration ID (from clinicaltrials.gov): NCT00504296
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 21, 2007 Closing Date: March 16, 2010



    		Permanently Closed
    I221

    A Dose-Ranging Study of IPH2201 in Patients with Gynecologic Malignancies


    A Dose-Ranging Study of IPH2201 in Patients with Gynecologic Malignancies

    Complexity Level: 1

    Eligibility: Patients with histologically and/or cytologically confirmed high-grade serous ovarian/fallopian tube or peritoneal carcinoma. Patients must have received prior cytotoxic chemotherapy (at least one regimen must have been platinum-containing) and may be either platinum sensitive or platinum resistant. Patients must have measurable disease per RECIST 1.1 and adequate organ function. Age >=18 years. ECOG 0, 1, or 2. Must have an available formalin fixed paraffin embedded tissue block from primary or metastatic tumour. For Part 2, must be willing to undergo a tumour biopsy prior to registration. Prior surgery and radiation permitted provided adequate time has elapsed form last dose. No active immune-mediated diseases including known HIV infection or hepatitis B/C. No systemic corticosteroid therapy at doses higher than 5 mg/day.

    Objectives: PRIMARY - To confirm the recommended phase II dose (RP2D) of single agent IPH2201 in patients with advanced/metastatic/recurrent platinum sensitive or resistant high-grade serous carcinoma (HGSC) of ovarian, fallopian tube or peritoneal origin. SECONDARY - (1) To characterize the pharmacokinetics of IPH2201 when administered as a single agent; (2) To assess the pharmacodynamic effects of single agent IPH2201; (3) To assess the safety and toxicity profile of single agent IPH2201; (4) To explore the efficacy of IPH2201 in platinum resistant or sensitive HGSC; (5) To characterize the immunogenicity of IPH2201 when administered as a single agent.

    NCT Registration ID (from clinicaltrials.gov): NCT02459301
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Permanently Closed
    Activation Date: August 24, 2015 Closing Date: April 20, 2017



    		Permanently Closed
    I203

    A Phase I Study of SB939 in Pediatric Patients with Refractory Solid Tumours and Leukemia.


    A Phase I Study of SB939 in Pediatric Patients with Refractory Solid Tumours and Leukemia.

    Complexity Level: 1

    Eligibility: Part A. Patients must have recurrent or refractory solid tumours, lymphoma or CNS tumours (excluding diffuse intrinsic pontine gliomas). Part B. Patients must have recurrent or refractory leukemia. Part C. Patients must have neuroblastoma, or medulloblastoma/CNS primitive neuroectodermal tumour (PNET). All patients must have histologic verification of malignancy, adequate bone marrow, renal, cardiac and liver function, and must meet all other eligibility criteria as defined in Protocol Section 5.

    Objectives: Part A. To determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of oral SB939 in pediatric patients with solid tumours, with SB939 administered orally every other day three times/week for three consecutive weeks, followed by one week off-dosing. Part B. To assess the tolerability of the solid tumour RP2D in patients with recurrent or refractory leukemia once the RP2D has been established in solid tumours. Part C. To determine the RP2D of oral SB939 in combination with a fixed dose of 13-cis-retinoic acid in children with refractory or recurrent neuroblastoma, medulloblastoma/CNS neuroectodermal tumour (PNET), using the recommended dose determined in Part A of this study. To characterize the pharmacokinetics of SB939 in a pediatric population. To describe any antitumour activity of SB939 in pediatric tumours when given as a single agent, and when given in combination with 13-cis-retinoic acid.

    NCT Registration ID (from clinicaltrials.gov): NCT01184274
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: September 21, 2010 Closing Date: January 25, 2012



    		Permanently Closed
    I147

    Phase I Study of GS7836 in Patients With Advanced Incurable Solid Tumours


    Phase I Study of GS7836 in Patients With Advanced Incurable Solid Tumours

    Eligibility: Histologically or cytologically documented solid tumour cancer. Clinically or radiologically documented disease. Up to three prior chemotherapy regimens permitted.

    Objectives: To determine the maximum tolerated dose (MTD) and recommended phase II dose of GS7836 in patients with solid tumours. To determine the safety, tolerability, toxicity profile, dose limiting toxicities and PK profile of GS7836. To assess the anti-tumour activity of GS7836 in patients with measurable disease.

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: September 28, 2001 Closing Date: February 17, 2004



    		Permanently Closed
    I123

    A Phase I Study of NX-211 Given as an IV Infusion Days 1, 2 & 3 Every 3 Weeks in Patients with Solid Tumours


    A Phase I Study of NX-211 Given as an IV Infusion Days 1, 2 & 3 Every 3 Weeks in Patients with Solid Tumours

    NCT Registration ID (from clinicaltrials.gov): NCT00003891
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: February 25, 1999 Closing Date: June 09, 2000



    		Permanently Closed
    I86

    NCIC CTG Phase I Study of 9-Aminocamptothecin (9-AC) Colloidal Dispersion (CD) Formulation Given as a 24 Hour Continuous Infusion Weekly x 4 Every 5 Weeks


    NCIC CTG Phase I Study of 9-Aminocamptothecin (9-AC) Colloidal Dispersion (CD) Formulation Given as a 24 Hour Continuous Infusion Weekly x 4 Every 5 Weeks

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: February 13, 1995 Closing Date: October 28, 1996



    		Permanently Closed
    I101

    NCIC CTG Phase I Dose Finding Study of RPR 109881A Administered as a Weekly 1-hour Intravenous Infusion to Patients With Advanced Solid Tumours


    NCIC CTG Phase I Dose Finding Study of RPR 109881A Administered as a Weekly 1-hour Intravenous Infusion to Patients With Advanced Solid Tumours

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: September 23, 1996 Closing Date: March 13, 1998



    		Permanently Closed
    I131

    A Phase I Study of ZD0473 and Docetaxel Given Once Every Three Weeks in Patients With Advanced Refractory Cancer


    A Phase I Study of ZD0473 and Docetaxel Given Once Every Three Weeks in Patients With Advanced Refractory Cancer

    Eligibility: Histologially documented advanced and/or metastatic solid tumours refractory to standard curative therapy or for which no curative therapy exists. Up to two prior chemotherapy regimens permitted.

    Objectives: To determine the maximum tolerated doses and recommended doses of ZD0473 and docetaxel when given in combination to patients with advanced cancer.

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: May 04, 2000 Closing Date: February 08, 2002



    		Permanently Closed
    I113

    NCIC CTG Phase I Interaction Study Between BAY 12-9566 and Modulated Dose Intensive Fluorouracil (Arm A) or Doxorubicin (Arm B) in Cancer Patients


    NCIC CTG Phase I Interaction Study Between BAY 12-9566 and Modulated Dose Intensive Fluorouracil (Arm A) or Doxorubicin (Arm B) in Cancer Patients

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: February 10, 1998 Closing Date: September 20, 1999



    		Permanently Closed
    I166

    This is a Multi-Centre, Open-Label, Dose-Escalating Phase I Clinical Trial of AEG35156 in Combination With Docetaxel in Patients With Solid Tumours


    This is a Multi-Centre, Open-Label, Dose-Escalating Phase I Clinical Trial of AEG35156 in Combination With Docetaxel in Patients With Solid Tumours

    Eligibility: Patients with histologically documented solid tumours, with locally advanced, metastatic or recurrent disease for which single agent docetaxel therapy is a reasonable therapeutic option. Presence of clinically and/or radiologically documented disease. ECOG performance status 0, 1 or 2. Prior chemotherapy (up to two prior regimens for metastatic/recurrent disease, and one regimen for adjuvant treatment, but no more than one taxane-containing regimen) is permitted. Prior surgery, hormone therapy, immunotherapy and radiation therapy are permitted.

    Objectives: To determine the maximum tolerated dose (MTD) and define a recommended phase II dose of AEG35156 administered intravenously in combination with docetaxel.

    NCT Registration ID (from clinicaltrials.gov): NCT00357747
    Participation: Participation in this phase I study is restricted to invited centres.
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 04, 2005 Closing Date: July 10, 2006



    		Permanently Closed
    I134

    A Phase I Study of BAY 38-3441 Given as a Short Infusion Daily For Five Days Every Three Weeks


    A Phase I Study of BAY 38-3441 Given as a Short Infusion Daily For Five Days Every Three Weeks

    Eligibility: Histologically documented advanced and/or metastatic solid tumours refractory to standard curative therapy or for which no curative therapy exists. Up to two prior chemotherapy regimens permitted.

    Objectives: To determine the maximum tolerated dose (MTD) and recommended dose of BAY38-3441 when given as a short daily infusion for five days every three weeks to patients with advanced cancer.

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: May 12, 2000 Closing Date: January 16, 2003



    		Permanently Closed
    I121

    A Phase I Study of LY335979 Administered in Combination With Vinorelbine in Patients With Solid Cancers


    A Phase I Study of LY335979 Administered in Combination With Vinorelbine in Patients With Solid Cancers

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: March 01, 1999 Closing Date: November 06, 2000



    		Permanently Closed
    I124

    A Phase I Study of MG98 Given as a 21 Day Continuous IV Infusion in Patients With Advanced Cancer


    A Phase I Study of MG98 Given as a 21 Day Continuous IV Infusion in Patients With Advanced Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: February 11, 1999 Closing Date: May 12, 2000



    		Permanently Closed
    I212

    A Pilot Study of Imetelstat given Intravenously on Day 1 and 8 of a 21 Day Schedule Alone and With Standard 13-Cis-Retinoic Acid in Children with Recurrent and/or Refractory Neuroblastoma.


    A Pilot Study of Imetelstat given Intravenously on Day 1 and 8 of a 21 Day Schedule Alone and With Standard 13-Cis-Retinoic Acid in Children with Recurrent and/or Refractory Neuroblastoma.

    Complexity Level: 1

    Eligibility: Patients must have recurrent or refractory neuroblastoma which is histologically verified at either original diagnosis or relapse.

    Objectives: 1.1 In patients with relapsed and/or refractory neuroblastoma, to confirm the feasibility of administering imetelstat given at the recommended pediatric dose as determined in the Children's Oncology Group Study ADVL1112 (a phase I study of imetelstat, a telomerase inhibitor, in children with recurrent or refractory solid tumours and lymphoma), alone and in combination with 13-cis-retinoic acid. 1.2 In patients with relapsed and/or refractory neuroblastoma to assess the impact of imetelstat on hematopoietic stem cells and neuroblastoma tumour initiating cells. 1.3 In patients with relapsed and/or refractory neuroblastoma to evaluate: - The correlation of tumour and plasma C-circles. - The role of plasma C-circles as a tumour biomarker for alternative lengthening of telomeres (ALT). - Changes in plasma C-circles induced by treatment with imetelstat.

    NCT Registration ID (from clinicaltrials.gov): NCT01916187
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 30, 2013 Closing Date: November 22, 2013



    		Permanently Closed
    I122

    A Phase I Study of Oral ZD1839 Given Daily in Patients With Solid Tumours


    A Phase I Study of Oral ZD1839 Given Daily in Patients With Solid Tumours

    Eligibility: Advanced and/or metastatic solid tumours, expected to have epidermal growth factor receptor (EGFR) mutation/over-expression and tissue accessible for needle biopsy. Prior chemotherapy permissible.

    Objectives: To determine the biologically active dose range (BADR) as evidence of target effect in a number of clinical correlative studies and MTD (if BADR is not defined prior to MTD) of oral ZD1839 when given daily. To determine safety/toxicity profile, dose limiting toxicities and pharmacokinetics of oral ZD1839.

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 14, 1999 Closing Date: June 28, 2001



    		Permanently Closed
    I200

    A Phase II Study of SB939 in Patients with Translocation-Associated Recurrent/Metastatic Sarcomas.


    A Phase II Study of SB939 in Patients with Translocation-Associated Recurrent/Metastatic Sarcomas.

    Complexity Level: 2

    Eligibility: Patients with histologically diagnosed translocation-associated sarcoma. Patients must have measurable disease. A tissue block from primary or metastatic tumour must be available for confirmation of diagnosis, translocation subtype and correlative studies. Up to 1 prior chemotherapy regimen in the metastatic setting is permitted. Prior radiation permitted. No pathologic cardiac arrhythmia within previous 12 months or myocardial infarction within 6 months. Acceptable end-organ function. ECOG 0, 1 or 2.

    Objectives: To determine the efficacy (as measured by objective response) of SB939 when given orally every other day 3 times a week, in patients with translocation-associated sarcomas. To determine response duration, stable disease rate and progression free survival in these patients. To determine the tolerability and toxicity of SB939 in this population. To explore potential molecular factors predictive of response in formalin fixed paraffin embedded specimens of patient sarcoma tissue.

    NCT Registration ID (from clinicaltrials.gov): NCT01112384
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: March 18, 2010 Closing Date: January 25, 2012



    		Permanently Closed
    I29

    NCIC CTG Phase II Study of Adriamycin/DTIC/Ifosfamide in Soft Tissue Sarcoma


    NCIC CTG Phase II Study of Adriamycin/DTIC/Ifosfamide in Soft Tissue Sarcoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 21, 1986 Closing Date: November 03, 1987



    		Permanently Closed
    I28A

    NCIC CTG Phase II Study of Trimetrexate (q 2wks) in Sarcoma


    NCIC CTG Phase II Study of Trimetrexate (q 2wks) in Sarcoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 25, 1988 Closing Date: January 09, 1989



    		Permanently Closed
    I55

    NCIC CTG Phase II Study of 10-edam in Soft Tissue Sarcoma


    NCIC CTG Phase II Study of 10-edam in Soft Tissue Sarcoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: September 04, 1990 Closing Date: March 06, 1992



    		Permanently Closed
    I136

    A Phase II Study of Flavopiridol (HMR 1275; NSC 649890) in Patients With Previously Untreated Recurrent Soft Tissue Sarcoma


    A Phase II Study of Flavopiridol (HMR 1275; NSC 649890) in Patients With Previously Untreated Recurrent Soft Tissue Sarcoma

    NCT Registration ID (from clinicaltrials.gov): NCT00005974
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 04, 2000 Closing Date: March 06, 2001



    		Permanently Closed
    I77

    NCIC CTG Phase II Study of Docetaxel in Recurrent or Metastatic Soft Tissue Sarcoma


    NCIC CTG Phase II Study of Docetaxel in Recurrent or Metastatic Soft Tissue Sarcoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: March 28, 1994 Closing Date: June 30, 1995



    		Permanently Closed
    I15

    NCIC CTG Phase II Study of Mitoxantrone in Sarcoma


    NCIC CTG Phase II Study of Mitoxantrone in Sarcoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 03, 1984 Closing Date: December 09, 1985



    		Permanently Closed
    I71

    NCIC CTG Phase II Study of Topotecan in Recurrent or Metastatic Soft Tissue Sarcoma


    NCIC CTG Phase II Study of Topotecan in Recurrent or Metastatic Soft Tissue Sarcoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 08, 1992 Closing Date: February 04, 1994



    		Permanently Closed
    I155

    A Phase II Study of Perifosine (D-21266) in Patients With Previously Untreated Metastatic or Locally Advanced Soft Tissue Sarcoma


    A Phase II Study of Perifosine (D-21266) in Patients With Previously Untreated Metastatic or Locally Advanced Soft Tissue Sarcoma

    Eligibility: Patients with histologically documented metastatic or locally advanced soft tissue sarcoma that is not curable by other means. Patients must not have received prior chemotherapy for metastatic disease. Prior adjuvant chemotherapy is permitted.

    Objectives: To assess the efficacy & toxicity of perifosine given by mouth for 3 weeks every 4 weeks in patients with untreated, metastatic or locally advanced soft tissue sarcoma. progression rate, and, if responses are observed, response duration.

    NCT Registration ID (from clinicaltrials.gov): NCT00053794
    Participation: Limited to invited centres only.
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: May 15, 2003 Closing Date: August 10, 2004



    		Permanently Closed
    I28

    NCIC CTG Phase II Study of Trimetrexate in Sarcoma


    NCIC CTG Phase II Study of Trimetrexate in Sarcoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 28, 1986 Closing Date: December 31, 1987



    		Permanently Closed

    Lung

    IDStudy TitleStatus
    BR38 (BR.38)

    Consolidative Use of Radiotherapy to Block (CURB2) Oligoprogression In Patients with Metastatic Non-Small-Cell Lung Cancer-A Randomized Phase 3 Trial


    Consolidative Use of Radiotherapy to Block (CURB2) Oligoprogression In Patients with Metastatic Non-Small-Cell Lung Cancer-A Randomized Phase 3 Trial

    Complexity Level: 2

    Eligibility: Participants with metatstatic, histologically confirmed non-small cell lung cancer, without an actionable driver mutataion, for whom either immune checkpoint inhibition (ICI) alone or in combination with chemotherapy is indicated. Participants must have oligoprogression on first-line ICI +/- chemotherapy after at least 3 cycles. All sites of oligopregression must be amenable to treatment with stereotactic body radiation therapy (SBRT) or ablative radiotherapy.

    Objectives: 1) To evaluate if the addition of SBRT to extra-cranial oligoprogressive metastatic disease can prolong progression-free survival (PFS) and/or overall survival (OS) compared to SOC systemic therapy alone in participants with oligoprogressive NSCLC. 2) To evaluate both treatment strategies with respect to: Safety and tolerability (using CTCAE Version 5.0); Participant-reported adverse events (using PRO-CTCAE questionnaire); Participant-reported quality of life (using EORTC-QLQ-C30 and QLQ-LC13 questionnaires); Cost-effectiveness (using EQ-5D-5L questionnaire; CCTG Canadian sites only) 3) To determine biomarkers of response and resistance using peripheral blood and tissue samples.

    NCT Registration ID (from clinicaltrials.gov): NCT06686771
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: CCTG Led Trial
    Status: Planned



    		Planned
    BR36 (CRI-CCTG-0002)

    A Biomarker-Directed, Multi-Centre Phase II/III Study of CTDNA Response Adaptive Immuno-Chemotherapy in Non-Small Cell Lung Cancer

    This is planned as a two stage study. Stage 1 of the study will evaluate if blood tests can be used to see how the cancer responds to treatment with pembrolizumab. Stage 2 will be finalized once stage 1 is completed with a plan to use blood tests to evaluate if patients whose cancer does not seem to be getting better on treatment with pembrolizumab would do better on a different treatment.

    A Biomarker-Directed, Multi-Centre Phase II/III Study of CTDNA Response Adaptive Immuno-Chemotherapy in Non-Small Cell Lung Cancer

    Complexity Level: 2

    Eligibility: Eligibility: MAIN INCLUSION CRITERIA: Patients with metastatic NSCLC that is EGFR and ALK mutation negative, PD-L1 expression Tumour Proportion Score (TPS) ≥ 50% who are willing and able to receive continued pembrolizumab or addition of standard platinum-based combination therapy added to pembrolizumab after initial 6 weeks (after 2 Q3W doses or 1 Q6W dose) of pembrolizumab as systemic immunotherapy. ECOG 0-2. Clinically/radiologically evaluable disease, RECIST 1.1 measurable disease not required. Mandatory blood collection of ctDNA for screening. MAIN EXCLUSION CRITERIA: Symptomatic/unstable CNS metastases. Patients who are not suitable candidates for treatment with pembrolizumab as a single agent or in combination with standard platinum combination chemotherapy.

    Objectives: Primary: Phase II progression free survival (PFS), Phase III overall survival (OS). Secondary: Phase II feasibility, RECIST response rate post randomization, safety/tolerability; Phase III RECIST response rate post randomization, response duration, progression free survival, and safety/tolerability.

    NCT Registration ID (from clinicaltrials.gov): NCT04093167
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: CCTG Led Trial
    Status: Open to Accrual
    Activation Date: October 17, 2019



    		Open to Accrual
    BRC8 (SWOG S1827)

    MRI Brain Surveillance Alone versus MRI Surveillance and Prophylactic Cranial Irradiation (PCI): A Randomized Phase III Trial in Small-Cell Lung Cancer (MAVERICK)

    Patients with Small Cell Lung Cancer can have disease that is confined to the chest (limited disease) or spread further (extensive disease). In both situations the initial treatment is chemotherapy, which very often substantially reduces the amount of disease present. Patients with limited disease are also treated with radiotherapy to the chest as are some patients with extensive disease. Unfortunately, even though chemotherapy and radiotherapy are usually successful in initially controlling SCLC, many patients with this disease eventually develop spread of the disease to the brain (brain metastases). Because of this, it is usual practice to administer brain irradiation to patients whose disease has responded to its initial treatment. This treatment does reduce the frequency of brain metastases, but radiation to the brain can impair thinking processes and it is not certain that giving radiation increases how long patients live. An alternative to administering radiation to all patients before they develop evidence of having spread of SCLC to the brain is to follow patients closely with regular imaging studies (Magnetic Resonance Imaging - MRIs) and to treat only those patients who develop brain metastases. Using this approach would mean that many patients would not suffer from loss of thinking function. The purpose of this study is to find out whether this latter approach can be substituted for the regular use of radiotherapy without affecting how long patients live

    MRI Brain Surveillance Alone versus MRI Surveillance and Prophylactic Cranial Irradiation (PCI): A Randomized Phase III Trial in Small-Cell Lung Cancer (MAVERICK)

    Complexity Level: 2

    Eligibility: Disease Related Criteria: a) Patient must have a histologically confirmed diagnosis of small-cell lung cancer(SCLC). b) Patient must have an MRI of the brain performed within 28 days prior to registration documenting no evidence of brain metastases or leptomeningeal disease. Patient also must not have a history of brain metastases or leptomeningeal disease. Prior/Concurrent Therapy Criteria: a) Immunotherapy concurrent with and/or adjuvant to first-line therapy is allowed at the discretion of the treating pysician. b) All adverse events from prior treatment must have resolved to Grade 2 (CTCAE Version 5.0) prior to randomization. c) Patient must have had a response to first-line therapy and no evidence of progression in opinion of the treating investigator. d) No more then 8 weeks elapsed between D1 of last cycle of chemotherapy and radomization e) Patient must not have received prior radiotherapy to the brain or WBRT.

    Objectives: Primary Objective: To evaluate whether overall survival (OS) with MRI surveillance alone is not inferior to MRI surveillance combined with prophylactic cranial irradiation (PCI) for the treatment of small cell lung cancer (SCLC). Secondary Objectives: To compare cognitive failure free survival (CFFS) rate up to 12 months after randomization between the arms. To compare brain-metastasis-free survival between the arms. To compare OS between the arms within the subgroups of patients with limited-stage and extensive-stage disease. To compare cognitive failure free survival (CFFS) rates at the assessment times between the arms. To compare the cumulative incidence of cognitive failure with death as a competing risk between the arms. To compare the frequency and severity of toxicities between the two arms. Additional Objectives: To collect blood for banking.

    NCT Registration ID (from clinicaltrials.gov): NCT04155034
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Open to Accrual
    Activation Date: May 27, 2020



    		Open to Accrual
    BRC6 (SWOG S1400)

    A Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer


    A Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer

    Complexity Level: 2

    Eligibility: PRE-SCREENING/SCREENING ELIGIBIILITY - patients must: (1) have pathologically proven Stage IV squamous cell lung cancer, (2) have an adequate tissue specimen as defined in the protocol and confirmed by the local pathologist, (3) not have a known EGFR mutation or ALK fusion, (4) must either be eligible to be screened at progression on prior treatment or to be pre-screened prior to progression on current treatment, (5) have Zubrod PS 0-1, (4) be > or = 18 years of age, (5) be offered participation in banking for future use of specimens (6) have previously received or currently be receiving a platinum-based chemotherapy regimen.

    Objectives: (1) to establish a NCTN mechanism for genomically screening large but homogeneous cancer populations & subsequently assigning and accruing simultaneously to a multi-sub-study Master Protocol. Each of the biomarker-driven sub-studies in this protocol will evaluate a targeted therapy (TT) or targeted therapy combination (TTC) based on a designated therapeutic biomarker-drug combination, with the ultimate goal being approval of new targeted therapies in this setting. Non-match sub-studies will evaluate nonmatch therapies (NMT) in patients not eligible for any of the biomarker-driven sub-studies, also with the goal of approval (2) to evaluate the screen success rate defined as the percentage of screened patients that register for a therapeutic sub-study, (3) to establish a tissue/ blood repository from patients with refractory squamous cell cancer.

    NCT Registration ID (from clinicaltrials.gov): NCT02154490
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: April 15, 2016 Closing Date: July 12, 2018



    		Closed to Accrual
    BRC5 (CALGB 140503)

    A Phase III Randomized Trial of Lobectomy Versus Sublobular Resection For Small, (</= to 2cm) Peripheral Non-Small Cell Lung Cancer


    A Phase III Randomized Trial of Lobectomy Versus Sublobular Resection For Small, (

    Complexity Level: 1

    Eligibility: Non Small Cell Lung Cancer - Stage 1

    Objectives: Primary Objective: To determine whether DFS after sublobar resection (segmentectomy or wedge) is non-inferior to that after lobectomy in patients with small peripheral NSCLC. Secondary Objectives: To determine whether overall survival(after sublobar resection) is non-inferior to that after lobectomy; to determine the rates of loco-regional and systemic recurrence (exclusive of second primaries) after lobar and sublobar resection; to determine the difference between the two arms of the study in pulmonary function as determined by expiratory flow rates measured at 6 months post-operatively. Imaging Substudy: To explore the relationship between characteristics of the primary lung cancer, as revealed by pre-operative CT and PET imaging, and outcomes; a determination of the false-negative rate of the pre-operative PET scan for identification of involved hilar and mediastinal lymph nodes; and an assessment of the utility of annual follow-up CT imaging after surgical resection.

    NCT Registration ID (from clinicaltrials.gov): NCT00499330
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: February 07, 2008 Closing Date: April 04, 2017



    		Closed to Accrual
    BRC6D (SWOG S1400D)

    A Phase II Study of AZD4547 for Previously Treated FGFR-Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-Map Sub-Study)


    A Phase II Study of AZD4547 for Previously Treated FGFR-Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-Map Sub-Study)

    Complexity Level: 2

    Eligibility: Patients must:(1)be assigned to BRC6D (i.e., defined as FGFR positive),(2)be 25 years,(3)not be taking drugs, herbal supplements or foods that are known to be strong/moderate CYP3A4-CYP2D6 substrates,(4)not have received nitrosourea or mitomycin C within 42 D prior to sub-study registration, (5) not have had any prior exposure to any agent with FGFR inhibition as its primary pharmacology,(6)not have a mean resting QTc > 450 msec obtained from 3 consecutive ECGs,(7)not be planning to receive any concomitant medication known to prolong QT interval, (8) be able to take oral medications,(9)not have a history of hypersensitivity to active or inactive excipients of AZD4547 or with a similar chemical structure or class,(10) not have any of the listed ophthalmological criteria, (11) have an eye exam,(12)have corrected Ca and Phos < ULN,(13)have MUGA/echocardiogram,(14)be offered participation in banking for future use of specimens,(15)see also common eligibility criteria of main BRC6 trial.

    Objectives: (1) within Ph II component of BRC6D, to evaluate if there is sufficient evidence to continue to Ph III by evaluating ORR with AZD4547 in FGFR-positive patients,(2) to evaluate investigator-assessed PFS & OS in FGFR-positive patients treated with AZD4547, (3) to evaluate duration of response (DoR) among FGFR positive patients treated with AZD4547 who achieve a CR or PR by RECIST 1.1, (4) to evaluate frequency & severity of toxicities associated with AZD4547 in FGFR positive patients, (5) to identify additional predictive tumour/blood biomarkers that may modify response or define resistance toAZD4547 beyond the chosen biomarker for biomarker-driven sub-studies, (6) identify potential resistance biomarkers at PD, (7) establish a tissue/ blood repository from patients with refractory squamous cell carcinoma of the lung.

    NCT Registration ID (from clinicaltrials.gov): NCT02154490
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: April 15, 2016 Closing Date: October 31, 2016



    		Closed to Accrual
    BRC6G (SWOG S1400G)

    A Phase II Study of Talazoparib (BMN 673) in Patients with Homologous Recombination Repair Deficiency Positive Stage IV Squamous Cell Lung Cancer (Lung-Map Sub-Study)


    A Phase II Study of Talazoparib (BMN 673) in Patients with Homologous Recombination Repair Deficiency Positive Stage IV Squamous Cell Lung Cancer (Lung-Map Sub-Study)

    Complexity Level: 2

    Eligibility: Patients must: (1) be assigned to BRC6G (i.e., defined as HRRD positive),(2) not have prior exposure to any agent with a PARP inhibitor,(3) have achieved SD, a PR, or a CR at their first assessment after initiating first-line platinum-based chemotherapy, (4) not have any impairment of GI function or GI disease that may significantly alter absorption of talazoparib, (5) be able to take oral medications, (6) not be taking, nor plan to take while on protocol treatment strong P-gp inhibitors, P-gp inducers, or BCRP inhibitors, (7) agree to have blood specimens submitted for PK analysis, (8) see also common eligibility criteria of main BRC6 trial.

    Objectives: (1) to evaluate the overall response rate (ORR) (confirmed and unconfirmed, complete and partial) with talazoparib in HRRD MDVN-positive patients, (2) to evaluate investigator- assessed PFS (IA-PFS) & OS associated with therapy in HRRD MDVN-positive patients, (3) to evaluate ORR, IA-PFS, and OS in HRRD FMI-positive patients, (4) to evaluate ORR in HRRD MDVN-negative/ HRRD FMI-positive patients, (5) to evaluate the frequency and severity of toxicities associated with talazoparib in HRRD FMI-positive patients, (6) to assess if the HRD score is associated with clinical outcomes (response, PFS, OS) in HRRD FMI-positive patients treated with talazoparib, (7) to assess if the level of PARP protein expression determined by immunohistochemistry is associated with clinical outcomes (response, PFS, OS) in HRRD FMI-positive patients treated with talazoparib, (8) to characterize pharmacokinetic properties of talazoparib.

    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: September 20, 2017 Closing Date: July 12, 2018



    		Closed to Accrual
    BR34

    A Randomized Trial of Durvalumab and Tremelimumab +/- Platinum Based Chemotherapy in Patients with Metastatic (Stage IV) Squamous or Non-Squamous Non-Small Cell Lung Cancer (NSCLC)


    A Randomized Trial of Durvalumab and Tremelimumab +/- Platinum Based Chemotherapy in Patients with Metastatic (Stage IV) Squamous or Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

    Complexity Level: 2

    Eligibility: - histologically and/or cytologically confirmed squamous or non-squamous NSCLC confirmed by IHC. Known EGFR mutations or ALK fusions are NOT eligible. - stage IVA or IVB per TNM version 8 staging criteria - must consent to tissue submission for PD-L1 testing. - measureable disease (RECIST 1.1) assessed within 28 days prior to randomization - 18 years of age or older - ECOG 0 or 1 - adequate hematology and biochemistry - no prior cytotoxic chemotherapy for advanced/metastatic disease - no prior EGFR, ALK inhibitors or immunotherapy

    Objectives: Primary Objective To compare the overall survival (OS) of patients receiving durvalumab, tremelimumab plus platinum-based chemotherapy to that of patients receiving durvalumab and tremelimumab alone. Secondary Objectives - To compare progression free survival (PFS; RECIST 1.1) at 1 year between arms - To compare objective response rate (ORR; RECIST 1.1 and iRECIST) between arms - To compare Quality of life (QoL) between arms - To evaluate the nature, severity, and frequency of toxicities between arms. - To evaluate the incremental cost effectiveness and cost utility ratios between arms - To correlate the expression of tissue (including PD-L1) and blood markers with outcomes and response. Exploratory Objectives - To evaluate the correlation between aberrations detected using genomic cell-free DNA in blood and outcomes - Progression free survival as defined by iRECIST

    NCT Registration ID (from clinicaltrials.gov): NCT03057106
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Closed to Accrual
    Activation Date: February 15, 2017 Closing Date: November 07, 2018



    		Closed to Accrual
    BRC6C (SWOG S1400C)

    A Phase II Study of Palbociclib for Previously Treated Cell Cycle Gene Alteration Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-Map Sub-Study)


    A Phase II Study of Palbociclib for Previously Treated Cell Cycle Gene Alteration Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-Map Sub-Study)

    Complexity Level: 2

    Eligibility: Patients must: (1) be assigned to BRC6C (i.e., defined as Cell Cycle Gene Alteration Positive, (2) not be taking within 7 days prior to sub-study registration, nor plan to take while on protocol treatment and for 14 days after the last dose of study treatment, strong CYP3A4 inhibitors and/or strong CYP3A4 inducers, and/or drugs known to prolong the QT interval, (3) not have a screening QTcF interval > 480 msec based on the average of triplicate EKGs performed within 28 days prior to registration, (4) be able to take oral medications, (5) be offered participation in banking for future use of specimens,(6) see also common eligibility criteria of main BRC6 trial.

    Objectives: (1) within Ph II component of BRC6C, to evaluate if there is sufficient evidence to continue to Ph III by evaluating ORR for cell cycle gene alteration positive patients registered to BRC6C treated with palbociclib,(2) to evaluate investigator-assessed PFS & OS cell cycle gene alteration-positive treatments with palbociclib, (3) to evaluate duration of response (DoR) among cell cycle gene alteration positive patients treated with palbociclib who achieve a CR or PR by RECIST 1.1, (4) to evaluate frequency & severity of toxicities associated with palbociclib, (5) to identify additional predictive tumour/blood biomarkers that may modify response or define resistance to palbociclib, (6) identify potential resistance biomarkers at PD, (7) establish a tissue/ blood repository from patients with refractory squamous cell carcinoma of the lung.

    NCT Registration ID (from clinicaltrials.gov): NCT02154490
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: April 15, 2016 Closing Date: September 01, 2016



    		Closed to Accrual
    BRC6I (SWOG S1400I)

    A Phase III Randomized Study of Nivolumab plus Ipilimumab versus Nivolumab for Previously Treated Patients with Stage IV Squamous Cell Lung Cancer and No Matching Biomarker (Lung-Map Sub-Study)


    A Phase III Randomized Study of Nivolumab plus Ipilimumab versus Nivolumab for Previously Treated Patients with Stage IV Squamous Cell Lung Cancer and No Matching Biomarker (Lung-Map Sub-Study)

    Complexity Level: 2

    Eligibility: Patients must (1)be assigned to BRC6I, (2) not had prior treatment with an anti-PD-1, anti-PDL1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways,(3) not have an active, known, or suspected autoimmune disease,(4) not have any known allergy or reaction to any component of the nivolumab & ipilimumab formulations,(5) not have received systemic treatment with corticosteroids or other immunosuppressive medications within 14 D,(6)not have a known + test for HBV sAg or HCV antibody indicating acute or chronic infection,(7) not have known history of testing positive for HIV or known AIDS,(8) not have interstitial lung disease that is symptomatic or disease that may interfere with the detection or management of suspected drug-related pulmonary toxicity,(9) must also be offered participation in banking for future use of specimens,(10) see also common eligibility criteria of main BRC6 trial.

    Objectives: (1) to compare OS in patients with advanced stage refractory SCCA of the lung randomized to nivolumab plus ipilimumab vs nivolumab, (2) to compare investigator-assessed PFS in patients with advanced stage refractory SCCA of the lung randomized to nivolumab plus ipilimumab vs nivolumab,(3) to compare the response rates (confirmed and unconfirmed, complete and partial) per RECIST 1.1 among patients randomized to receive nivolumab plus ipilimumab vs nivolumab,(4) to compare the response rates (confirmed only, complete and partial) per RECIST 1.1 among patients randomized to receive nivolumab plus ipilimumab vs nivolumab, (5) to evaluate the frequency and severity of toxicities associated with nivolumab plus ipilimumab vs nivolumab, (6) to evaluate if there is an differential treatment effect on OS, IA-PFS, and Response by tumor PD-L1 expression status.

    NCT Registration ID (from clinicaltrials.gov): NCT02154490
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: April 15, 2016 Closing Date: April 23, 2018



    		Closed to Accrual
    BRC7 (ECOG-ACRIN EA5163)

    INSIGNA: A Randomized, Phase III Study of Firstline Immunotherapy alone or in Combination with Chemotherapy in Induction/Maintenance or Post Progression in Advanced Nonsquamous Non-Small Cell Lung Cancer (NSCLC) with Immunobiomarker SIGNature-driven Analysis


    INSIGNA: A Randomized, Phase III Study of Firstline Immunotherapy alone or in Combination with Chemotherapy in Induction/Maintenance or Post Progression in Advanced Nonsquamous Non-Small Cell Lung Cancer (NSCLC) with Immunobiomarker SIGNature-driven Analysis

    Complexity Level: 2

    Eligibility: Patients must have histologically or cytologically confirmed stage IV non-squamous NSCLC (includes M1a, M1b, and M1c stage disease. Patients with T4NX disease (Stage IIIB) with nodule in ipsilateral lung lobe are eligible if they are not candidates for combined chemotherapy and radiation. Patients must have PD-L1 expression Tumor Proportion Score (TPS)greater than or equal to 1% in tumor cells. Patients must have measurable or non-measureable disease.

    Objectives: Co-primary objective is to evaluate overall survival (OS) in each of the 2 experimental arms (Arms A and B) to control (Arm C). To evaluate progression-free survival (PFS) for Arm C versus each of Arms A and B; best objective response rates for Arm C versus each of Arms A and B; to estimate toxicity within each of the treatment arms via the CTCAE criteria, compare outcomes b/w Arms A & B, and outcomes by treatment arm within subgroups defined by a cutpoint of PD-L1 expression at > 50%.

    NCT Registration ID (from clinicaltrials.gov): NCT03793179
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: July 10, 2019 Closing Date: March 01, 2024



    		Closed to Accrual
    BRC6F (SWOG S1400F)

    A Phase II Study of MEDI4736 (Durvalumab) Plus Tremelimumab as Therapy for Patients with Previously Treated Anti-PD-1/PD-L1 Resistant Stage IV Squamous Cell Lung Cancer (Lung-MAP Non-Match Sub-Study)


    A Phase II Study of MEDI4736 (Durvalumab) Plus Tremelimumab as Therapy for Patients with Previously Treated Anti-PD-1/PD-L1 Resistant Stage IV Squamous Cell Lung Cancer (Lung-MAP Non-Match Sub-Study)

    Complexity Level: 2

    Eligibility: Patients must:(1)be assigned to BRC6F (2)have progressed during/after prior platinum-based chemo, or after anti-PD-1/anti-PD-L1 Ab monotherapy (3)no prior exposure to CTLA-4 inhibitors (ipilimumab & tremelimumab) (4)not received nitrosoureas or mitomycin-c within 42 d (5)no prior autoimmune/inflammatory disease within 3 y (6)no history of primary immunodeficiency (7)no immunosuppressive meds within 28 d. Systemic corticosteroids stopped at least 24 h (8) no Gr 3 or worse irAE (9)no organ transplant that requires immunosuppressives (10)no allergy/reaction to Durvalumab &/or tremelimumab (11)no active tuberculosis infection (12)no live attenuated vaccination within 28 d (13)no known HIV, or + test for Hep B virus surface antigen (HBV sAg), or Hep C virus ribonucleic acid (HCV Ab) indicating current acute/chronic infection (14)have TSH with reflex T3/T4 free (if TSH is out of normal range) & ECG within 7 d (15)specimen banking (16)see also common eligibility criteria of main BRC6 trial.

    Objectives: (1) to evaluate ORR (confirmed & unconfirmed, CR & PR) by RECIST 1.1 among patients treated with Durvalumab + Tremelimumab (2) to estimate DoR among patients who achieve a CR or PR (confirmed and unconfirmed) by RECIST 1.1 (3) to estimate the DoR per immune-related response criteria for patients who achieve a CR or PR (confirmed & unconfirmed) by RECIST 1.1 (4) to evaluate OS for patients treated with Durvalumab + Tremelimumab (5) to evaluate IA-PFS for patients treated with Durvalumab + Tremelimumab (6) to evaluate IA-PFS assessed by immune-related response criteria (irRC-IA-PFS) for patients treated with Durvalumab + Tremelimumab (7) to evaluate the frequency & severity of toxicities associated with Durvalumab + Tremelimumab (8) to explore the association of potential predictive markers identified in BRC6A, with response & PFS (9) to explore the association of PD-L1 expression status with response & PFS (10) to contribute to an ongoing BRC6 serum & tumor bank.

    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: February 27, 2018 Closing Date: July 12, 2018



    		Closed to Accrual
    BRC6B (SWOG S1400B)

    A Phase II Study of GDC-0032 (Taselisib) for Previously Treated PI3K Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-Map Sub-Study)


    A Phase II Study of GDC-0032 (Taselisib) for Previously Treated PI3K Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-Map Sub-Study)

    Complexity Level: 2

    Eligibility: Patients must:(1) be assigned to BRC6B (i.e., defined as PI3K positive after biomarker testing),(2) have a HbAic <7% and fasting glucose < 125 mg/dL,(3) not have Type I or II diabetes that requires anti-hyperglycemic medication,(4) not have active or history of small or large intestine inflammation (eg. Crohn's disease or ulcertive colitis),(5) not require daily supplemental O2,(6) be able to take oral medications. Patients may not have any impairment or gastrointestinal function or disease that may significantly alter absorption of Taselisib-eg. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection,(7) not be taking, or plan to take while on protocol treatment and for 14 days post last dose of study treatment, drugs, herbal supplements, or foods that are known to be strong/moderate CYP3A4 substrates,(8) be offered participation in banking for future use of specimens,(9) see also common eligibility criteria of main BRC6 trial.

    Objectives: (1) to evaluate Taselisib (GDC-0032), a PI3K inhibitor, in PI3K-positive patients,(2) within Ph II component of BRC6B, to evaluate if there is sufficient evidence to continue to Ph III,(3) to evaluate investigator-assessed PFS & OS (4)to evaluate ORR,(5) to establish a tissue/blood repository from patients with refractory lung squamous cell carcinoma, (6) to evaluate DOR,(7) to evaluate frequency & severity of toxicities associated with Taselisib,(8) to identify additional predictive tumour/blood biomarkers that may modify response or define resistance to Taselisib,(9) to identify potential resistence biomarkers at PD.

    NCT Registration ID (from clinicaltrials.gov): NCT02154490
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: April 15, 2016 Closing Date: December 13, 2016



    		Closed to Accrual
    BR31

    A Phase III Prospective Double Blind Placebo Controlled Randomized Study of Adjuvant MEDI4736 in Completely Resected Non-Small Cell Lung Cancer


    A Phase III Prospective Double Blind Placebo Controlled Randomized Study of Adjuvant MEDI4736 in Completely Resected Non-Small Cell Lung Cancer

    Complexity Level: 2

    Eligibility: Completely resected primary stage IB (>= 4cm), II and IIIA non-small cell lung cancer patients (with or without adjuvant platinum based chemotherapy).

    Objectives: Primary Objective: Disease free survival (DFS) for patients with NSCLC that is PD-L1 positive. Disease free survival (DFS) in all randomized patients. Secondary Objectives: Overall survival (OS) for patients with NSCLC that is PD-L1 positive, OS for all randomized patients, lung cancer specific survival for patients with NSCLC that is PD-L1 positive and all randomized patients, adverse effects and tolerability of MEDI4736, Quality of Life, survival benefits participants judge necessary to make adjuvant immunotherapy worthwhile, economic evaluation (cost effectiveness and cost utility), evaluation of predictive/prognostic significance of PD-L1 expression, evaluation of changes in plasma/serum cytokines and other blood and tissue based biomarkers after treatment with MEDI4736 and at disease event, exploratory pharmacogenomic assays (baseline only).

    NCT Registration ID (from clinicaltrials.gov): NCT02273375
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Closed to Accrual
    Activation Date: October 09, 2014 Closing Date: March 27, 2020



    		Closed to Accrual
    BRC2E (BRC2E)

    A Prospective Economic Analysis of NCIC CTG BRC.2/E1505 A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB (>/= 4 cm) - IIIA Non-Small Cell Lung Cancer (NSCLC)


    A Prospective Economic Analysis of NCIC CTG BRC.2/E1505 A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB (>/= 4 cm) - IIIA Non-Small Cell Lung Cancer (NSCLC)

    Complexity Level: 3

    Eligibility: All Canadian patients registered to BRC.2.

    Objectives: Primary Objective: To determine the incremental cost effectiveness ratio of adding bevacizumab to cisplatin-based chemotherapy as adjuvant treatment after resection of Stage IB (>= 4 cm) to IIIA NSCLC in the BRC.2/E1505 (core protocol) randomized trial. Direct medical costs will be estimated from the perspective of the Canadian public healthcare system. Secondary Objectives: To determine the direct medical costs of adjuvant chemotherapy plus bevacizumab in the BRC.2/E1505 trial. To determine the incremental cost effectiveness of bevacizumab plus cisplatin-based adjuvant chemotherapy in preplanned patient subsets in the BRC.2/E1505 trial by, smoking status, stage (IB, II, IIIA, N2), gender, chemotherapy type, and predictive molecular factors, (VEGF, ICAM serum levels).

    NCT Registration ID (from clinicaltrials.gov): no NCT
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 28, 2007 Closing Date: September 20, 2013



    		Permanently Closed
    BR22 (S9900)

    A Randomized Phase III Trial of Surgery Alone or Surgery Plus Preoperative Paclitaxel/Carboplatin in Clinical Stage IB(T2N0), II(T1-2N1, T3N0) and Selected IIIA(T3N1) Non-Small Cell Lung Cancer.


    A Randomized Phase III Trial of Surgery Alone or Surgery Plus Preoperative Paclitaxel/Carboplatin in Clinical Stage IB(T2N0), II(T1-2N1, T3N0) and Selected IIIA(T3N1) Non-Small Cell Lung Cancer.

    Complexity Level: 2

    Eligibility: Patients must have pathologic documentation of non-small cell lung cancer. Clinical stage IB (T2N0), selected clinical stage II (T1-2N1 with negative mediastinoscopy or T3N0) or selected clinical stage IIIA (T3N1) with negative mediastinoscopies. Level 10 hilar nodes may be positive as long as the mediastinoscopy is negative. All patients must have measurable disease.

    Objectives: To assess whether preoperative chemotherapy with paclitaxel and carboplatin for 3 cycles improves survival compared to surgery alone in previously untreated patients with clinical Stage 1B II and Selected III A non-small cell lung cancer (NSCLC). To compare operative mortality and other toxicities in the two study arms. To evaluate the response rates (confirmed and unconfirmed, complete and partial) and the toxicities associated with the combination of paclitaxel and carboplatin. To obtain samples for correlation of pathologic, molecular and biologic factors with outcome.

    NCT Registration ID (from clinicaltrials.gov): NCT00004011
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: March 26, 2002 Closing Date: July 15, 2004



    		Permanently Closed
    BR25

    A Phase II Study of Hypofractionated 3-Dimensional Conformal Radiotherapy (3DCRT)For Inoperable Stage I/II Non-Small Cell Lung Cancer (NSCLC)


    A Phase II Study of Hypofractionated 3-Dimensional Conformal Radiotherapy (3DCRT)For Inoperable Stage I/II Non-Small Cell Lung Cancer (NSCLC)

    Complexity Level: 1

    Eligibility: Histological or cytological confirmation of non-small cell lung cancer The following primary cancer types:squamous cell,adenocarcinoma, large cell, bronchioloalveolar cell, or non-small cell carcinoma not otherwise specified. If sputum cytology alone is used for diagnosis, this should be confirmed on a second specimen. Cytologic specimens obtained by brushing, washing or needle aspiration of a defined lesion are acceptable.

    Objectives: To measure the local tumour control rate at 2 years after the delivery of an accelerated hypofractionated course of radiotherapy to patients with stage I/II (peripheral T1-3, N0, M0) non-small cell lung cancer (NSCLC). To measure the toxicities associated with the treatment, the rates of regional and distant recurrence, progression-free survival and overall survival,the changes in pulmonary function after treatment. To assess quality of life (QOL) after treatment.

    NCT Registration ID (from clinicaltrials.gov): NCT00346320
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 26, 2006 Closing Date: April 18, 2008



    		Permanently Closed
    BR26

    A Double Blind Placebo Controlled Randomized Trial of PF-804 in Patients With Incurable Stage IIIB/IV Non-small Cell Lung Cancer After Failure of Standard Therapy for Advanced or Metastatic Disease


    A Double Blind Placebo Controlled Randomized Trial of PF-804 in Patients With Incurable Stage IIIB/IV Non-small Cell Lung Cancer After Failure of Standard Therapy for Advanced or Metastatic Disease

    Complexity Level: 2

    Eligibility: Advanced previously treated Non-Small Cell Lung Cancer

    Objectives: Progression free survival and Overall survival

    NCT Registration ID (from clinicaltrials.gov): NCT01000025
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: September 04, 2009 Closing Date: June 13, 2013



    		Permanently Closed
    BR8

    A Randomized Phase III Study of CODE Plus Thoracic Irradiation Versus Alternating CAV and EP for Extensive Stage Small Cell Lung Cancer


    A Randomized Phase III Study of CODE Plus Thoracic Irradiation Versus Alternating CAV and EP for Extensive Stage Small Cell Lung Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: October 16, 1992 Closing Date: April 26, 1996



    		Permanently Closed
    BR3

    Clinical Trial of Alternating versus Sequential Combination Chemotherapy and Loco-regional Chemotherapy for the Treatment of Limited Small Cell Carcinoma of the Lung


    Clinical Trial of Alternating versus Sequential Combination Chemotherapy and Loco-regional Chemotherapy for the Treatment of Limited Small Cell Carcinoma of the Lung

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: December 01, 1981 Closing Date: October 01, 1984



    		Permanently Closed
    BR24

    A Phase II/III Double Blind Randomized Trial of AZD2171 versus Placebo in Patients Receiving Paclitaxel/Carboplatin Chemotherapy for the Treatment of Advanced or Metastatic Non-Small Cell Lung Cancer


    A Phase II/III Double Blind Randomized Trial of AZD2171 versus Placebo in Patients Receiving Paclitaxel/Carboplatin Chemotherapy for the Treatment of Advanced or Metastatic Non-Small Cell Lung Cancer

    Complexity Level: 2

    Eligibility: Histologically or cytologically confirmed diagnosis of stage IIIB or stage IV NSCLC. For phase II, the first 150 patients must have unidimensionally measurable disease by RECIST criteria. Prior adjuvant chemotherapy permitted (completed >=12 months), prior EGFR inhibitor therapy permitted (completed >=14 days). No prior anti-angiogenesis therapy permitted, no prior chemotherapy for metastatic or recurrent disease permitted. Patients must be > 21 days since radiation therapy and > 14 days since previous surgery.

    Objectives: Phase II: To compare the progression-free survival between arms. To compare the objective tumour response rate in each arm. To evaluate the nature, severity, and frequency of toxicities, including hemorrhage and hemoptysis between the two arms. To examine pharmacogenomic and pharmacodynamic aspects of treamtent. Phase III: To compare overall survival between the two arms. To compare progression-free survival between arms. To compare objective response rates (RR) in each arm. To estimate time to response and response duration. To evaluate the nature, severity, and frequency of toxicities, including hemorrhage and hemoptysis between the two arms. To correlate the expression of tissue markers (at diagnosis) with outcomes and response. To compare Quality of Life between the two arms.

    NCT Registration ID (from clinicaltrials.gov): NCT00245154
    Participation: Limited to invited centres only.
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: September 07, 2005 Closing Date: February 25, 2008



    		Permanently Closed
    BR18

    A Phase II/III Double Blind Randomized Trial of BMS-275291 versus Placebo in Patients Receiving Paclitaxel/Carboplatin Chemotherapy For the Treatment of Advanced or Metastatic Non-Small Cell Lung Cancer


    A Phase II/III Double Blind Randomized Trial of BMS-275291 versus Placebo in Patients Receiving Paclitaxel/Carboplatin Chemotherapy For the Treatment of Advanced or Metastatic Non-Small Cell Lung Cancer

    Eligibility: Histologically or cytologically confirmed diagnosis of non-small cell carcinoma of the lung. Cytologic specimens obtained by brushing, washing or needle aspiration of a defined lesion are acceptable. Patients with Stage IIIB or Stage IV NSCLC, or local or metastatic failure after surgery and/or radiotherapy are eligible. Patients with Stage IIIB NSCLC without pleural effusion who are not candidates for combined modality treatment or who are being treated at centres where combined modality treatment is not the standard of practice are also eligible.

    Objectives: Phase II - To evaluate the incidence of grade 2 or higher drug related arthritis, arthralgia and/or myalgia in each arm - To estimate the objective tumour response rate in each arm - To evaluate the nature, severity, and frequency of toxicities Phase III Primary Objective: - To compare overall survival (OS) between the 2 arms Secondary Objectives: - To compare progression-free survival (PFS) - To compare response rates (RR) - To estimate time to response and response duration - To compare the nature, severity, and frequency of toxicities between the 2 arms - To correlate the expression of tissue MMP levels (at diagnosis) with outcomes and response to treatment - To correlate serum/plasma MMPs and other markers with outcomes and response to treatment - To compare Quality of Life between the 2 arms - To collect and compare resource utilization for a health economic analysis in North American centres between the 2 treatment arms

    NCT Registration ID (from clinicaltrials.gov): NCT00006229
    Participation: Limited to European and North American Centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 04, 2000 Closing Date: May 20, 2002



    		Permanently Closed
    BR22C (S9925)

    This Protocol is a Laboratory Companion for Southwest Oncology Group Coordinated Trials for Lung Cancer


    This Protocol is a Laboratory Companion for Southwest Oncology Group Coordinated Trials for Lung Cancer

    Eligibility: Only patients previously registered to Southwest Oncology Group lung cancer treatment protocols will be registered to this study.

    Objectives: To establish a central lung cancer specimen repository to serve as a resource for current and future scientific studies. To utilize the Southwest Oncology Group clinical data base to perform clinicopathologic correlation with the results of those studies.

    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: March 26, 2002 Closing Date: July 15, 2004



    		Permanently Closed
    BRC3 (S0124)

    Randomized Phase III Trial of Cisplatin and Irinotecan (NSC-616348) Versus Cisplatin and Etoposide in Patients With Extensive Stage Small Cell Lung Cancer (E-SCLC)


    Randomized Phase III Trial of Cisplatin and Irinotecan (NSC-616348) Versus Cisplatin and Etoposide in Patients With Extensive Stage Small Cell Lung Cancer (E-SCLC)

    Eligibility: Histologic/cytologic confirmed E-SCLC Measurable or non-measurable disease Performance status: 0-1 Patient must be at least 3 weeks post surgery Patients with brain mets eligible only of controlled Blood counts and liver function test results must be within range provided in protocol.

    Objectives: Compare the survival of patients with extensive stage small cell lung cancer (E-SCLC) treated with cisplatin & irinotecan vs cisplatin and & compare progression-free survival, toxicities and response rate in patients with E-SCLC treated with cisplatin and irinotecan versus cisplatin and etoposide. Assess the association between UGT1A1 polymorphisms and irinotecan-associated toxicities in patients with E-SCLC. Assess the association between ERCC-1 and XRCC-1 polymorphisms and non-response to cisplatin & irinotecan & to cisplatin and etoposide.

    NCT Registration ID (from clinicaltrials.gov): NCT00045162
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: March 12, 2004 Closing Date: March 01, 2007



    		Permanently Closed
    BR9

    A Phase III Prospective Randomized Study of Combination Chemotherapy and Surgery Versus Radiotherapy for Stage IIIA Non-Small Cell Lung Cancer


    A Phase III Prospective Randomized Study of Combination Chemotherapy and Surgery Versus Radiotherapy for Stage IIIA Non-Small Cell Lung Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: May 05, 1993 Closing Date: November 03, 1994



    		Permanently Closed
    BR15C (S9925)

    This Protocol is a Laboratory Companion for Southwest Oncology Group Coordinated Trials for Lung Cancer


    This Protocol is a Laboratory Companion for Southwest Oncology Group Coordinated Trials for Lung Cancer

    Eligibility: Only patients previously registered to Southwest Oncology Group lung cancer treatment protocols will be registered to this study.

    Objectives: To establish a central lung cancer specimen repository to serve as a resource for current and future scientific studies. To utilize the Southwest Oncology Group clinical data base to perform clinicopathologic correlation with the results of those studies. To test new hypotheses as they emerge.

    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: June 15, 2002 Closing Date: April 15, 2005



    		Permanently Closed
    BR7

    A Pilot Study of Radiotherapy Fractionation for the Treatment of Limited Small Cell Carcinoma of the Lung


    A Pilot Study of Radiotherapy Fractionation for the Treatment of Limited Small Cell Carcinoma of the Lung

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 15, 1987 Closing Date: May 17, 1988



    		Permanently Closed
    BR21

    A Randomized Placebo Controlled Study of OSI-774 (Tarceva) in Patients with Incurable Stage IIIB/IV Non-Small Cell Lung Cancer Who Have Failed Standard Therapy for Advanced or Metastatic Disease


    A Randomized Placebo Controlled Study of OSI-774 (Tarceva) in Patients with Incurable Stage IIIB/IV Non-Small Cell Lung Cancer Who Have Failed Standard Therapy for Advanced or Metastatic Disease

    Eligibility: Incurable stage IIIB/IV non-small cell lung cancer who have failed at least one prior regimen, but no more than two prior regimens for advanced or metastatic disease.

    Objectives: To compare overall survival; secondary endpoints include progression-free survival, response rates, duration of response, toxicity and tolerability, QoL QLQ C30 + QLQ LC13: all patients, tissue EGFR versus outcome and response, OSI-744 trough PK.

    NCT Registration ID (from clinicaltrials.gov): NCT00026325
    Participation: Not limited
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 14, 2001 Closing Date: January 31, 2003



    		Permanently Closed
    BR16 (ECOG E5597)

    Phase III Chemoprevention Trial of Selenium Supplementation in Persons With Resected Stage 1 Non-Small Cell Lung Cancer


    Phase III Chemoprevention Trial of Selenium Supplementation in Persons With Resected Stage 1 Non-Small Cell Lung Cancer

    Complexity Level: 3

    Eligibility: Patients who have undergone complete resection of a histologically proven stage 1A (pT1N0) or 1B (pT2N0) non-small cell lung cancer (except carcinod) who are currently free of disease. To be pathologic stage N0, at least one mediastinal node must have been sampled at resection. Centres who are participating on NCIC CTG study BR.10 may not randomize patients with stage T2N0 until BR.10 closes to accrual.

    Objectives: To evaluate the efficacy of selenium supplementation in reducing the incidence of second primary lung tumours in patients who have been treated for Stage 1 non-small cell lung cancer with complete surgical resection. To evaluate the qualitative and quantitative toxicity of selenium supplementation in a daily administration schedule. To compare the incidence of specific cancers and mortality from cancer as well as overall survival of patients treated with selenium supplementation versus patients treated with placebo.

    NCT Registration ID (from clinicaltrials.gov): NCT00008385
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: November 23, 2000 Closing Date: November 05, 2009



    		Permanently Closed
    BR1




    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 01, 1973 Closing Date: July 04, 1975



    		Permanently Closed
    BR28 (MLCG CONVERT)

    Concurrent ONce-daily VErsus twice-daily RadioTherapy: A 2-arm randomised controlled trial of concurrent chemo-radiotherapy comparing twice-daily and once-daily radiotherapy schedules in patients with limited stage small cell lung cancer (SCLC) and good performance status


    Concurrent ONce-daily VErsus twice-daily RadioTherapy: A 2-arm randomised controlled trial of concurrent chemo-radiotherapy comparing twice-daily and once-daily radiotherapy schedules in patients with limited stage small cell lung cancer (SCLC) and good performance status

    Complexity Level: 2

    Eligibility: Patients with histologically or cytologically confirmed small cell lung cancer (SCLC). Performance status must be ECOG grade 0-1. Patients with PS 2 whose general condition is explained by obstructive/bulky disease likely to improve after the first cycle of chemotherapy can be included at the discretion of the local investigator.

    Objectives: Overall survival Local progression-free survival; Metastasis-free survival; CTCAE v3.0 toxicity; Cytotoxic dose intensity; Radiotherapy dose intensity; Prospective cost-effectiveness analysis.

    NCT Registration ID (from clinicaltrials.gov): NCT00433563
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: December 09, 2008 Closing Date: July 22, 2013



    		Permanently Closed
    BR13 (93-09)

    A Phase III Comparison Between Concurrent Chemotherapy Plus Radiotherapy and Concurrent Chemotherapy Plus Radiotherapy Followed by Surgical Resection For Stage IIIA (N2) Non-Small Cell Lung Cancer


    A Phase III Comparison Between Concurrent Chemotherapy Plus Radiotherapy and Concurrent Chemotherapy Plus Radiotherapy Followed by Surgical Resection For Stage IIIA (N2) Non-Small Cell Lung Cancer

    Complexity Level: 2

    Eligibility: Patients with histologically proven primary non-small cell lung cancer (T 1-3, N 2-3, M0).

    Objectives: To determine if chemotherapy, radiotherapy and surgery is superior to chemotherapy and radiotherapy. To evaluate patterns of local and distant failure.

    NCT Registration ID (from clinicaltrials.gov): NCT00002550
    Participation: Limited to centres with current CPA #
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: October 15, 1996 Closing Date: November 30, 2001



    		Permanently Closed
    BR23C (S9925)

    This Protocol is a Laboratory Companion for Southwest Oncology Group Coordinated Trials for Lung Cancer


    This Protocol is a Laboratory Companion for Southwest Oncology Group Coordinated Trials for Lung Cancer

    Eligibility: Only patients previously registered to Southwest Oncology Group lung cancer treatment protocols will be registered to this study.

    Objectives: To establish a central lung cancer specimen repository to serve as a resource for current and future scientific studies. To utilize the Southwest Oncology Group clinical database to perform clinicopathologic correlation with the results of those studies. To test a new hypotheses as they emerge.

    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: February 10, 2004 Closing Date: October 01, 2007



    		Permanently Closed
    BR29

    A Double Blind Randomized Trial of Cediranib versus Placebo in Patients Receiving Paclitaxel/Carboplatin Chemotherapy for the Treatment of Advanced or Metastatic Non-Small Cell Lung Cancer


    A Double Blind Randomized Trial of Cediranib versus Placebo in Patients Receiving Paclitaxel/Carboplatin Chemotherapy for the Treatment of Advanced or Metastatic Non-Small Cell Lung Cancer

    Complexity Level: 2

    Objectives: This is a randomized, double blind, placebo controlled study of cediranib (AZD2171) given in combination with standard paclitaxel/carboplatin chemotherapy in patients with stage IIIB or IV non-small cell lung cancer. An early futility interim analysis is planned. Primary objective: To compare the overall survival between the 2 arms

    NCT Registration ID (from clinicaltrials.gov): NCT00795340
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: November 06, 2008 Closing Date: May 06, 2011



    		Permanently Closed
    BRC4 (N0723)

    A Phase III Biomarker Validation Study of Second-Line Therapy in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Randomized to Pemetrexed Versus Erlotinib


    A Phase III Biomarker Validation Study of Second-Line Therapy in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Randomized to Pemetrexed Versus Erlotinib

    Eligibility: Documented recurrence or disease progression of NSCLC Measurable disease of at least 2cm; ECOG PS = 0, 1 or 2; Negative pregnancy test; Ability to provide informed consent; Life expectancy > 12wks; Tissue available and willing to submit tissue for EGFR evaluation; Must be previously treated for advanced disease with only 1 chemotherapy regimen which must contain cytotoxic agent(s); Able to take folic acid, vitamin B12 supplementation, and dexamethasone; Able to permanently discontinue aspirin dose of greater or equal to 1.3 grams/day 10 days before and after pemetrexed treatment; Stable brain mets; Willingness to return to enrolling institution for treatment and follow-up.

    Objectives: Primary: To evaluate whether there are differences in progression free survival due to treatment with erlotinib compared to pemetrexed for subsets of previously treated NSCLC patients defined by epidermal growth factor receptor (EGFR)-FISH positivity versus negativity

    NCT Registration ID (from clinicaltrials.gov): NCT00738881
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: May 14, 2009 Closing Date: November 13, 2009



    		Permanently Closed
    BR10

    A Phase III Prospective Randomized Study of Adjuvant Chemotherapy with Vinorelbine and Cisplatin in Completely Resected Non-Small Cell Lung Cancer with Companion Tumour Marker Evaluation


    A Phase III Prospective Randomized Study of Adjuvant Chemotherapy with Vinorelbine and Cisplatin in Completely Resected Non-Small Cell Lung Cancer with Companion Tumour Marker Evaluation

    NCT Registration ID (from clinicaltrials.gov): NCT00002583
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 07, 1994 Closing Date: April 30, 2001



    		Permanently Closed
    BR5

    A) Clinical Trial of Two Regimens of Combination Chemotherapy Compared to Best Supportive Care or B) Clinical Trial of Two Regimens of Combination Chemotherapy for the Treatment of Extensive Non-small Cell Carcinoma of the Lung


    A) Clinical Trial of Two Regimens of Combination Chemotherapy Compared to Best Supportive Care or B) Clinical Trial of Two Regimens of Combination Chemotherapy for the Treatment of Extensive Non-small Cell Carcinoma of the Lung

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: November 22, 1982 Closing Date: January 01, 1986



    		Permanently Closed
    BR20

    A Phase II Study of ZD6474 or Placebo in Small Cell Lung Cancer Patients Who Have Complete or Partial Response to Induction Chemotherapy Plus Radiation Therapy


    A Phase II Study of ZD6474 or Placebo in Small Cell Lung Cancer Patients Who Have Complete or Partial Response to Induction Chemotherapy Plus Radiation Therapy

    Eligibility: Patients must have histological or cytological proof of small cell carcinoma of the lung. Patients must have achieved a complete or partial response after chemotherapy +/- radiotherapy. Patients must have received a minimum of 4 cycles of the first line combination chemotherapy within 28 days of randomization. Radiology must be performed within 28 days of randomization and must show continued CR or PR. Patients must have a current performance status of ECOG 0, 1 or 2. Patient must have a life expectancy of at least 12 weeks and be 16 years of age or older.aen of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test. Patient is able and willing to complete the quality of life questionnaires in either English or French. Patients registered on this trial must be treated and followed at the participating centres.

    Objectives: To compare progression-free survival (PFS) for small cell lung cancer (SCLC) patients who have received either ZD6474 or placebo. To compare the response rate (for patients with measurable disease outside the radiation field at entry) for SCLC patients who have received either ZD6474 or placebo. To compare toxicity and tolerability for SCLC patients who have received either ZD6474 or placebo. To assess pharmacokinetics for SCLC patient who received either ZD6474 or placebo: To compare QoL for SCLC patients who have received either ZD6474 or placebo. To confirm the prognostic significance of VEGFR (± p-VEGFR) expression and microvessel density in tumour with outcomes and response to treatment for consenting patients who had a histological specimen at diagnosis (section 18). To provide a comprehensive tumour, plasma and urine bank (section 17 and 18) linked to a clinical database for the further study of molecular markers in SCLC.

    NCT Registration ID (from clinicaltrials.gov): NCT00066313
    Participation: Limited to 20 NCIC CTG centres.
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: May 12, 2003 Closing Date: March 13, 2006



    		Permanently Closed
    BR23 (S0220)

    A Phase II Trial of Induction Chemoradiotherapy with Cisplatin/Etoposide Followed by Surgical Resection, Followed by Docetaxel, for Non-Small Cell Lung Cancer Involving the Superior Sulcus (Pancoast Tumours)


    A Phase II Trial of Induction Chemoradiotherapy with Cisplatin/Etoposide Followed by Surgical Resection, Followed by Docetaxel, for Non-Small Cell Lung Cancer Involving the Superior Sulcus (Pancoast Tumours)

    Complexity Level: 2

    Eligibility: Histologically confirmed newly diagnosed single primary bronchogenic NSCLC,selected Stage IIB,IIIA or IIIB due to involvement of superior sulcus(T3-4,NO-1).EKG.Evidence of disease by chest x-ray (PA & lateral views),chest CT preferable w/contrast)with bone windows,CT scan of upper abd or PET scan (not necessary if chest CT incl.liver and adrenals).Biopsy or aspiration of suspicious CT/MRI findings.Pleural effusion negative per Section 5.5.Pre-resection FEV1 greater than or equal to 2.0 L,or if FEV1 less than 2.0,predicted post-resection FEV1 greater than 1.0L. PS 0-2 (PS2 must have albuin greater than or equal to 0.85 x 1LLN, wt loss less than or equal to 10%).ANC greater than or equal to 1,500,PLTS greater than or equal to 100,000.Adequate hepatic function,total bili & SGOT or SGPT less than or equal to 1.5 x 1ULN (unless benign dz present).CrCl greater than or equal to 50 ml/min. Must have mediastinal exploration w/lymph nodes biopsied except if mediastinum neg by both CT/PET.

    Objectives: The main objective of this Phase II study is to assess whether a regimen of cisplatin and etoposide with concurrent RT, followed by surgical resection and consolidation therapy with docetaxel has promise in terms of its feasibility for treating patients with Pancoast tumours Stage IIIA.

    NCT Registration ID (from clinicaltrials.gov): NCT00062439
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: February 10, 2004 Closing Date: October 01, 2007



    		Permanently Closed
    BR12

    A Phase III Study of Marimastat in Patients with Small Cell Lung Cancer Following a Response to First Line Chemotherapy


    A Phase III Study of Marimastat in Patients with Small Cell Lung Cancer Following a Response to First Line Chemotherapy

    NCT Registration ID (from clinicaltrials.gov): NCT00003011
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 31, 1997 Closing Date: April 28, 2000



    		Permanently Closed
    BR2

    Clinical Trial in Bronchogenic Carcinoma of Specific Immunotherapy as an Adjuvant to Surgery


    Clinical Trial in Bronchogenic Carcinoma of Specific Immunotherapy as an Adjuvant to Surgery

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: May 01, 1978 Closing Date: December 31, 1983



    		Permanently Closed
    BR17 (08983)

    Phase III Study of Tomudex and Cisplatin versus Cisplatin in Malignant Pleural Mesothelioma


    Phase III Study of Tomudex and Cisplatin versus Cisplatin in Malignant Pleural Mesothelioma

    Eligibility: Histologically proven diagnosis of malignant mesothelioma of the pleura. Independent review of the pathology slides will be carried out on all patients.

    Objectives: To compare overall survival between the two treatment regimens in patients with malignant pleural mesothelioma. To determine toxicity, progression-free survival and Quality of Life. In the patient population with measurable disease, objective response to treatment and duration of response will be assessed.

    NCT Registration ID (from clinicaltrials.gov): NCT00004920
    Participation: Not limited
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: February 14, 2000 Closing Date: January 03, 2003



    		Permanently Closed
    BR15 (S0023)

    A Phase III Trial of Cisplatin/Etoposide/Radiotherapy With Consolidation Docetaxel Followed by Maintenance Therapy with ZD1839 or Placebo in Patients with Inoperable Locally Advanced Stage III Non-Small Cell Lung Cancer


    A Phase III Trial of Cisplatin/Etoposide/Radiotherapy With Consolidation Docetaxel Followed by Maintenance Therapy with ZD1839 or Placebo in Patients with Inoperable Locally Advanced Stage III Non-Small Cell Lung Cancer

    Eligibility: Either histologic or cytologic proof of a newly diagnosed single, primary bronchogenic non-small cell lung cancer is required (adenocarcinoma, non-lobar and non-diffuse bronchioloalveolar cell carcinoma, large cell carcinoma or squamous cell carcinoma). A biopsy with histology is preferred, but cytology is allowed. Histology or cytology from involved mediastinal or supraclavicular lymph nodes alone will be allowed if a separate distal primary lesion is clearly evident on radiographs (i.e. a second biopsy will not be required).

    Objectives: To assess whether cisplatin plus etoposide with concurrent radiotherapy followed by three cycles of consolidation docetaxel followed by maintenance therapy with ZD1839 compared to placebo improves overall survival and progression-free survival in patients with unresectable Stage III non-small cell lung cancer (NSCLC). To describe the toxicity profile of long-term administration of ZD1839.

    NCT Registration ID (from clinicaltrials.gov): NCT00020709
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: April 10, 2002 Closing Date: April 15, 2005



    		Permanently Closed
    BR19 (BR19)

    A Phase III Prospective Randomized Double Blind Placebo Controlled Trial of the Epidermal Growth Factor Receptor Antagonist ZD1839 (IRESSA) in Completely Resected Stage 1B, II, and IIIA Non-Small Cell Lung Cancer


    A Phase III Prospective Randomized Double Blind Placebo Controlled Trial of the Epidermal Growth Factor Receptor Antagonist ZD1839 (IRESSA) in Completely Resected Stage 1B, II, and IIIA Non-Small Cell Lung Cancer

    Eligibility: Patients who have histologic evidence of stage IB, II or IIIA primary non-small cell lung cancer that has been completely resected.

    Objectives: To compare whether adjuvant treatment with ZD1839 (IRESSA) is superiour to placebo in patients with completely resected stage IB, II and IIIA non-small cell lung cancer in terms of : overall survival and disease-free survival. To confirm the prognostic significance and to assess the predictive ability of EGFR expression, phosphorylation and mutations and the likelihood of "response" to ZD1839 (IRESSA) in terms of overall survival. A comprehensive tumour bank will be established and linked to the clinical database for the further study of molecular markers in non-small cell lung cancer. The toxicity related to ZD1839 (IRESSA) will be further evaluated.

    NCT Registration ID (from clinicaltrials.gov): NCT00049543
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: September 13, 2002 Closing Date: April 22, 2005



    		Permanently Closed
    BR4

    Clinical Trial of Standard versus Alternating Combination Chemotherapy for the Treatment of Extensive Small Cell Carcinoma of the Lung


    Clinical Trial of Standard versus Alternating Combination Chemotherapy for the Treatment of Extensive Small Cell Carcinoma of the Lung

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: November 11, 1982 Closing Date: April 01, 1985



    		Permanently Closed
    BR6

    A Clinical Trial of Early Versus Late Radiotherapy for Treatment of Limited Small Cell Carcinoma of the Lung


    A Clinical Trial of Early Versus Late Radiotherapy for Treatment of Limited Small Cell Carcinoma of the Lung

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 15, 1985 Closing Date: December 16, 1988



    		Permanently Closed
    BRC2 (ECOG 1505)

    A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB (>/= 4 cm) - IIIA Non-Small Cell Lung Cancer (NSCLC)


    A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB (>/= 4 cm) - IIIA Non-Small Cell Lung Cancer (NSCLC)

    Complexity Level: 2

    Eligibility: To be eligible for the trial, all patients must have undergone complete resection of their cancer prior to enrollment. It is expected that at a minimum, mediastinal lymph node systematic sampling will have occurred, though complete mediastinal lymph node dissection (MLND) will be preferred.

    Objectives: Primary Objective: To evaluate overall survival with chemotherapy with or without bevacizumab used in the adjuvant setting in patients with resected stage IB (>/= 4 cm) - IIIA NSCLC. Secondary Objectives: To evaluate disease free survival and toxicity with chemotherapy with or without bevacizumab used in the adjuvant setting in patients with resected stage IB (>/= 4 cm) - IIIA NSCLC. To perform analyses of tissue and blood to establish factors that predict for clinical outcome in patients receiving chemotherapy, with or without bevacizumab, for resected early stage NSCLC. To determine whether smoking status is linked to outcome for patients with resected stage IB (>/= 4 cm) - IIIA NSCLC treated with chemotherapy with or without bevacizumab in the adjuvant setting.

    NCT Registration ID (from clinicaltrials.gov): NCT00324805
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: August 28, 2007 Closing Date: September 20, 2013



    		Permanently Closed
    BR11 (9416)

    Induction Chemoradiotherapy Followed by Surgical Resection for Non-Small Cell Lung Cancer Involving the Superior Sulcus (Pancoast Tumours): A Phase II Trial


    Induction Chemoradiotherapy Followed by Surgical Resection for Non-Small Cell Lung Cancer Involving the Superior Sulcus (Pancoast Tumours): A Phase II Trial

    NCT Registration ID (from clinicaltrials.gov): NCT00002642
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: July 10, 1995 Closing Date: August 01, 1999



    		Permanently Closed
    BR14 (GEM/VIN 3)

    A Phase III Study of Gemcitabine Plus Vinorelbine Compared to Standard Cisplatin Containing Chemotherapy For Stage IIIb or IV Non-Small Cell Lung Cancer


    A Phase III Study of Gemcitabine Plus Vinorelbine Compared to Standard Cisplatin Containing Chemotherapy For Stage IIIb or IV Non-Small Cell Lung Cancer

    NCT Registration ID (from clinicaltrials.gov): NCT00004100
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: December 17, 1999 Closing Date: March 15, 2001



    		Permanently Closed
    BRC1 (RTOG 0214)

    A Phase III Comparison of Prophylactic Cranial Irradiation Versus Observation in Patients With Locally Advanced Non-Small Cell Lung Cancer


    A Phase III Comparison of Prophylactic Cranial Irradiation Versus Observation in Patients With Locally Advanced Non-Small Cell Lung Cancer

    Complexity Level: 2

    Eligibility: Patients with Stage IIIA or IIIB non-small cell lung cancer having completed all planned definitive locoregional therapy (chemotherapy alone does not constitute definitive therapy) or locoregional and systemic therapy (with or without surgery) with complete response, partial response or stable disease after therapy. Eligible patients must have had an MRI or CT scan of the head showing no suspicion for CNS metastases within 6 weeks of study entry. Patients will not be eligible for the study if there is evidence of progressive disease, extracranial distant metastatic disease or if treated with prior cranial irradiation

    Objectives: To determine whether prophylactic cranial irradiation (PCI) improves survival after effective locoregional/systemic therapy for patients with locally advanced non-small cell lung cancer. To determine the neurolopsychologic impact of PCI, the impact of PCI on quality of life, and the impact of PCI on the incidence of CNS metastases.

    NCT Registration ID (from clinicaltrials.gov): NCT00048997
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: October 04, 2002 Closing Date: August 30, 2007



    		Permanently Closed

    Melanoma

    IDStudy TitleStatus
    SKC1 (NRG-HN014)

    Randomized Phase III Trial of Neoadjuvant Immunotherapy with Response-Adapted Treatment Versus Standard-Of-Care treatment For Resectable Stage III/IV Cutaneous Squamous Cell Carcinoma


    Randomized Phase III Trial of Neoadjuvant Immunotherapy with Response-Adapted Treatment Versus Standard-Of-Care treatment For Resectable Stage III/IV Cutaneous Squamous Cell Carcinoma

    Complexity Level: 2

    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Planned



    		Planned
    ME13

    A Randomized Phase III Trial of the Duration of Anti-PD-1 Therapy in Metastatic Melanoma (STOP-GAP)

    "PD-1 inhibitors" are new immunotherapeutic agents effective in prolonging survival in metastatic melanoma. Currently, patients are being offered continuous treatment with approved and publically-funded PD-1 inhibitors for 24 months. However, some data suggest that patients respond early and may respond again at treatment re-induction. Given that PD-1 inhibitors are expensive and may lead to serious immune-related adverse reactions, the optimal treatment duration for these agents is one of the key questions for clinicians, governments and patients. This trial hypothesizes that intermittent PD-1 inhibitor treatment, following maximum benefit on initial treatment, is no worse for survival compared to continuous treatment for 24 months. If confirmed, this strategy will be practice-changing and it is anticipated that it will result in less toxicities, better quality of life and decreased costs.

    A Randomized Phase III Trial of the Duration of Anti-PD-1 Therapy in Metastatic Melanoma (STOP-GAP)

    Complexity Level: 2

    Eligibility: Patients with unresectable / metastatic (stage III or stage IV) melanoma, who are eligible to receive Health Canada approved, publically-funded PD-1 inhibitors.

    Objectives: PRIMARY: To determine whether the Overall Survival (OS) of patients randomized to intermittent PD-1 inhibitor therapy is non-inferior to that of patients randomized to continuous PD-1 inhibitor therapy, in unresectable / metastatic (stage III or stage IV) melanoma. SECONDARY OBJECTIVES: (1) Progression-Free Survival, (2) Response rate and duration of response, (3) Adverse Events profile, (4) Quality of Life and (5) Economic Evaluation

    NCT Registration ID (from clinicaltrials.gov): NCT02821013
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: CCTG Led Trial
    Status: Open to Accrual
    Activation Date: July 04, 2016



    		Open to Accrual
    MEC6 (ALLIANCE A091903)

    A Randomized Phase II Trial of Adjuvant Nivolumab with or without Cabozantinib in Patients with Resected Muscosal Melanoma

    Using Nivolumab alone or with Cabozantinib to prevent mucosal melanoma return after surgery

    A Randomized Phase II Trial of Adjuvant Nivolumab with or without Cabozantinib in Patients with Resected Muscosal Melanoma

    Complexity Level: 2

    Eligibility: Histologically proven mucosal melanoma by local pathology; central PD-L1 tissue tumour submission; Resected R0 or R1 disease; non-resected R2 or metastatic disease that is assessable and measurable; no prior systemic checkpoint inhibitor therapy of mucosal melanoma; age 18 or older.

    Objectives: To compare the efficacy of adjuvant nivolumab (480mg q4 weeks) versus nivolumab plus cabozantinib (40 mg daily) in patients with mucosal melanoma. The primary objective will be measured as a comparison of duration of recurrence free survival (RFS) between the arms. Secondary objectives: OS, adverse effects by treatment arm, correlation between PD-L1 expresssion in tumour cells with RFS and OS; to evaluate ORR, DOR, PFS and OS of nivo plus cabo in patients who cannot undergo gross total resection of disease or have metastatic disease at baseline.

    NCT Registration ID (from clinicaltrials.gov): NCT05111574
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Open to Accrual
    Activation Date: July 08, 2022



    		Open to Accrual
    ME17

    A Phase II Randomized Trial of LND101 for Fecal Microbiota Transplantation in Combination with Immune Checkpoint Blockade in Patients with Advanced Melanoma

    Standard of care immunotheraputic agents called immune checkpoint blockade (ICB) are effective in prolonging survival in metastatic melanoma. However, more than half of patients with melanoma experience resistance to ICB. Some data suggests that an individual's gut microbiota is a key determinant of ICB activity. Gut mirobiota can be altered in individuals through oral supplementation of bacteria in a process called fecal microbiota transplantation (FMT). The purpose of this study is to compare standard of care ICB, to standard of care ICB with FMT treatment. This will help us determine if altering the gut microbiome can help ICB treatment reduce the progression of advanced melanoma.

    A Phase II Randomized Trial of LND101 for Fecal Microbiota Transplantation in Combination with Immune Checkpoint Blockade in Patients with Advanced Melanoma

    Complexity Level: 2

    Eligibility: MAIN INCLUSION CRITERA: Adults over 18 years of age with histological diagnosis of cutaneous melanoma or melanoma of unknown primary; Confirmed stage IV or advanced unresectable melanoma; Must have measurable disease; ECOG 0-2; No prior ICB treatment for advanced unresectable or metastatic disease; Able to ingest capsules. MAIN EXCLUSION CRITERIA: Antibiotic treatment in last 14 days; Corticosteroid use of > 10mg per day; Any absolute contraindications to FMT ; Active infections requiring antibiotic treatment.

    Objectives: PRIMARY: Progression Free Survival (PFS) (per RECIST 1.1 and iRECIST) in standard of care ICB arm vs. standard of care ICB + FMT arm. SECONDARY: Compare treatment arms with respect to Overall Survival (OS), Objective Response Rate (ORR), and safety and tolerability. EXPLORATORY: To evaluate acquired donor-host similarity and its association with PFS in the FMT treatment arm; to evaluate engraftment and its association with progression-free survival in the FMT treatment arm; to evaluate the impact of FMT on the gut microbiota, gut metabolome and systemic immune response.

    NCT Registration ID (from clinicaltrials.gov): NCT06623461
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Open to Accrual
    Activation Date: December 13, 2024



    		Open to Accrual
    ME15 (MASC-MELMART-II)

    Melanoma Margins Trial: A Phase III, Multi-centre, Multi-national Randomized Control Trial Investigating 1cm vs 2cm Wide Excision Margins for Primary Cutaneous Melanoma (MelMarT-II)

    Patients with a primary invasive melanoma are recommended to undergo excision of the primary lesion with a wide margin. There is evidence that less radical margins of excision may be just as safe. This is a randomised controlled trial of 1 cm versus 2 cm margin of excision of the primary lesion for adult patients with stage II primary invasive cutaneous melanomas (AJCC 8th edition) to determine differences in disease-free survival. A reduction in margins is expected to improve patient quality of life.

    Melanoma Margins Trial: A Phase III, Multi-centre, Multi-national Randomized Control Trial Investigating 1cm vs 2cm Wide Excision Margins for Primary Cutaneous Melanoma (MelMarT-II)

    Complexity Level: 2

    Eligibility: Patients are eligible if all the following requirements are met: 18 years or older, Histologically confirmed, primary invasive cutaneous melanoma: AJCC 8th edition Stage IIA-IIC (pT2b-pT4b), ECOG performance status 0-1 at randomisation, able to give informed consent, and comply with protocol treatment and follow up, randomisation and treatment must be performed within 120 days of diagnosis, patients must have no previous malignancy or primary except low-risk non-melanoma skin cancer (unless in remission and >5 years since diagnosis).

    Objectives: This study will determine whether there is a difference in disease free survival for patients treated with either a 1cm excision margin or 2cm margin for clinical stage II (pT2b-pT4b) primary cutaneous melanoma (AJCC 8th edition).The study is designed to be able to prove or disprove that there is no difference in risk of melanoma recurrence between the two groups of patients. This study is designed to show that the risk of long-term pain associated with surgery can be reduced. If the study achieves its primary objective and demonstrates safety with a narrower margin, then we will also be able to determine how much of an impact the narrower excision has on patients in terms of improved quality of life and reduced side effects from the surgery and melanoma disease. This trial will also evaluate and determine the economic impact of narrower excision margins on the health services and society in general.

    NCT Registration ID (from clinicaltrials.gov): NCT03860883
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Open to Accrual
    Activation Date: July 30, 2020



    		Open to Accrual
    ME13L

    A Biomarker Sub-study of the CCTG ME.13 Duration of Anti PD-1 Therapy in Metastatic Melanoma STOP-GAP Trial


    A Biomarker Sub-study of the CCTG ME.13 Duration of Anti PD-1 Therapy in Metastatic Melanoma STOP-GAP Trial

    Complexity Level: 2

    Eligibility: Participants of the main ME.13 trial enrolled at a Canadian centre who consent to submit a blood sample for buffy-coat and at least one additional biospecimen category.

    Objectives: PRIMARY OBJECTIVE: To profile human bodily material (HBM) before, during and/or post-treatment with immune-checkpoint inhibitors (ICI) to characterize predictive biomarkers of key clinical outcomes of response, progression free and overall survival, and immune related toxicity during continuous and discontinuous ICI therapy regimens from the ME13 clinical trial. SECONDARY OBJECTIVES: (1) To identify spatial relationships between immune and melanoma cells in the pre-treatment tumour microenvironment (TME) that predict clinical outcomes; (2) To define mRNA expression and epigenetic changes in single exhausted CD8+ T cells and other immune cells that correlate with ICI response during continuous vs. intermittent ICI treatment; (3) To determine whether multi-dimensional molecular profiling of melanomas and circulating immune cells can identify a subset of markers to best predict clinical outcomes.

    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: CCTG Led Trial
    Status: Open to Accrual
    Activation Date: November 14, 2023



    		Open to Accrual
    MEC3 (ECOG E1609)

    A Phase III Randomized Study of Adjuvant Ipilimumab Anti-CTLA4 Therapy versus High-Dose Interferon a-2b for Resected High-Risk Melanoma


    A Phase III Randomized Study of Adjuvant Ipilimumab Anti-CTLA4 Therapy versus High-Dose Interferon a-2b for Resected High-Risk Melanoma

    Complexity Level: 2

    Eligibility: Patients enrolled in this study must have a diagnosis of primary cutaneous melanoma (high risk stage IIIB - IV as per AJCC Melanoma Staging System), and must have completely surgically resected disease at baseline. Patients must have been surgically rendered free of disease with negative margins, and must have a disease free status documented by a complete physical examination and imaging studies within 4 weeks prior to randomization. Some patients with disease recurrence after adequate surgical excision of the original primary melanoma are allowed as well, as specified in the protocol. A total of 1500 patients will be enrolled over 3.3 years. Accrual rate is expected to be 38 per month, and with additional follow up time, a total duration of study is expected to be less than 6 years.

    Objectives: Primary Objectives: " To evaluate recurrence-free survival (RFS) between patients randomized to receive post-operative adjuvant ipilimumab given at either 10 mg/kg (high dose ipilimumab; HIP) or 3 mg/kg (low dose ipilimumab: LIP) versus those randomized to receive HDI utilizing a hierarchical design assessing HIP versus HDI first and LIP versus HDI second (if the first comparison is significant). " To evaluate overall survival (OS) between patients randomized to receive post-operative adjuvant ipilimumab given at either 10 mg/kg (HIP) or 3 mg/kg (LIP) versus those randomized to receive HDI utilizing a hierarchical design assessing HIP versus HDI first and LIP versus HDI second (if the first comparison is significant). Secondary Objectives: " To evaluate safety and tolerability of post-operative adjuvant ipilimumab therapy given at either 10 mg/kg (HIP) or 3 mg/kg (LIP).

    NCT Registration ID (from clinicaltrials.gov): NCT01274338
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: October 02, 2012 Closing Date: August 15, 2014



    		Closed to Accrual
    MEC5 (SWOG 1404)

    A Phase III Randomized Trial Comparing Physician/Patient Choice of Either High Dose Interferon or Ipilimumab to MK-3475 (Pembrolizumab) in Patients with High Risk Resected Melanoma


    A Phase III Randomized Trial Comparing Physician/Patient Choice of Either High Dose Interferon or Ipilimumab to MK-3475 (Pembrolizumab) in Patients with High Risk Resected Melanoma

    Complexity Level: 2

    Eligibility: Patients enrolled in this study must have completely resected melanoma of cutaneous origin (stage IIIA (N2a), IIIB, IIIC, or Stage IV) or of unknown primary. Patients with melanoma of mucosal or other non-cutaneous origin are eligible except for those with melanoma of ocular origin. Patients with a history of brain metastases are ineligible. For all patients, all disease must have been resected with negative pathological margins and no clinical radiologic or pathological evidence of any incompletely resected melanoma. Patients must be registered with 98 day of the last surgery performed to render the patient free of disease. Accrual rate is expected to be 45 patients per month with a total of 1240 patients enrolled in less than 2.5 years.

    Objectives: Primary Objectives: a.Compare overall survival (OS) of patients with resected Stage III and IV melanoma treated with high dose interferon alfa-2b versus MK-3475 (pembrolizumab) b.Among patients who are PD-L1 positive, to compare OS of patients with resected Stage III and IV melanoma treated with high dose interferon alfa-2b versus MK-3475 (pembrolizumab) c.Compare relapse-free survival (RFS) of patients with resected Stage III and IV melanoma treated with high dose interferon alfa-2b to MK-3475 (pembrolizumab) d.Among patients who are PD-L1 positive, to compare RFS of patients with resected Stage III and IV melanoma treated with high dose interferon alfa-2b to MK-3475 (pembrolizumab) Secondary Objectives: a. Estimate OS and RFS for patients who are PD-L1 negative or PD-L1 indeterminate in this population. b. Compare OS and RFS of patients between the two regimens within PD-L1 positive and negative subgroups and to look at the interaction between PD-L1 and treatment arm.

    NCT Registration ID (from clinicaltrials.gov): NCT02506153
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: January 15, 2016 Closing Date: November 02, 2017



    		Closed to Accrual
    ME10 (ECOG E1697)

    Phase III Randomized Study of Four Weeks High Dose IFN-a2b in Stage T2b N0, T3a-bN0, T4a-b N0, and T1-4, N1a, 2a (microscopic) Melanoma


    Phase III Randomized Study of Four Weeks High Dose IFN-a2b in Stage T2b N0, T3a-bN0, T4a-b N0, and T1-4, N1a, 2a (microscopic) Melanoma

    Complexity Level: 2

    Eligibility: Patients with resected melanoma in the following categories: (1) T3-N0 (1.5-4 mm), (2) T4-N0 (> 4 mm), (3) T1-4 (microscopic, one lymph node positive).

    Objectives: To compare the effect of treatment with four weeks of high dose IFN alpha-2b versus observation on relapse free survival and overall survival. Also, toxicities and quality-adjusted survival will be compared in the two groups.

    NCT Registration ID (from clinicaltrials.gov): NCT00003641
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: September 14, 1999 Closing Date: October 26, 2010



    		Closed to Accrual
    ME1

    NCIC First Cooperative Clinical Trial of Adjuvant Immunotherapy for Malignant Melanoma


    NCIC First Cooperative Clinical Trial of Adjuvant Immunotherapy for Malignant Melanoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: February 15, 1978 Closing Date: December 31, 1982



    		Permanently Closed
    ME5

    National Intergroup Protocol For Intermediate Thickness Melanomas 1.0 to 4.0mm Evaluation of Optimal Surgical Margins (2 Vs 4cm) Around the Primary Melanoma and Evaluation of Elective Regional Lymph Node Dissection


    National Intergroup Protocol For Intermediate Thickness Melanomas 1.0 to 4.0mm Evaluation of Optimal Surgical Margins (2 Vs 4cm) Around the Primary Melanoma and Evaluation of Elective Regional Lymph Node Dissection

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: October 01, 1983 Closing Date: March 16, 1993



    		Permanently Closed
    ME8

    A Double-Blind, Placebo-Controlled, Randomized Phase III Study Comparing the Complete and Partial Response Rates of a Combination of Carmustine (BCNU), Dacarbazine (DTIC) and Cisplatin With and Without Tamoxifen in Patients with Metastatic Melanoma


    A Double-Blind, Placebo-Controlled, Randomized Phase III Study Comparing the Complete and Partial Response Rates of a Combination of Carmustine (BCNU), Dacarbazine (DTIC) and Cisplatin With and Without Tamoxifen in Patients with Metastatic Melanoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: February 26, 1992 Closing Date: January 31, 1995



    		Permanently Closed
    ME7

    A Comparison of Immunomodulating Doses of Human Interferon Gamma with Levamisole for the Adjuvant Treatment of Poor Prognosis Malignant Melanoma


    A Comparison of Immunomodulating Doses of Human Interferon Gamma with Levamisole for the Adjuvant Treatment of Poor Prognosis Malignant Melanoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: November 04, 1988 Closing Date: May 10, 1990



    		Permanently Closed
    MEC4 (ALLIANCE A091201)

    Randomized Phase II Study Comparing the MET Inhibitor Cabozantinib to Temozolomide/Dacarbazine in Ocular Melanoma


    Randomized Phase II Study Comparing the MET Inhibitor Cabozantinib to Temozolomide/Dacarbazine in Ocular Melanoma

    Complexity Level: 2

    Eligibility: Patients with ocular melanoma that is metastatic or unresectable

    Objectives: Primary Objective: Compare the progression-free survival rate at 4 months (PFS4) of patients with ocular melanoma treated with cabozantinib or temozolomide / dacarbazine. Secondary Objectives: Estimate the distribution of progression-free survival (PFS) times; Estimate the distribution of overall survival (OS) times; Estimate the confirmed response rate as determined by the RECIST criteria; Assess the safety of these agents by examining the toxicity profile; Correlate the response of MET molecular status.

    NCT Registration ID (from clinicaltrials.gov): NCT01835145
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: July 09, 2015 Closing Date: May 06, 2016



    		Permanently Closed
    ME2

    NCIC Collaborative Study of Vinblastine, Bleomycin and Cisplatinum in the Treatment of Metastatic Malignant Melanoma


    NCIC Collaborative Study of Vinblastine, Bleomycin and Cisplatinum in the Treatment of Metastatic Malignant Melanoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: February 11, 1981 Closing Date: June 08, 1982



    		Permanently Closed
    ME6 (8593)

    A Randomized Trial of Prophylactic Isolation Perfusion for Stage I High Risk Malignant Melanoma of the Limbs


    A Randomized Trial of Prophylactic Isolation Perfusion for Stage I High Risk Malignant Melanoma of the Limbs

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: October 30, 1986 Closing Date: June 14, 1988



    		Permanently Closed
    ME3

    NCIC Study of CCNU, Vincristine and Procarbazine in the Treatment of Metastatic Malignant Melanoma


    NCIC Study of CCNU, Vincristine and Procarbazine in the Treatment of Metastatic Malignant Melanoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 30, 1982 Closing Date: September 01, 1983



    		Permanently Closed

    Others

    IDStudy TitleStatus
    PM1

    Canadian Profiling and Targeted agent Utilization tRial (CAPTUR). A Phase II Basket Trial.

    Recent advances in laboratory technology have enabled the identification of changes in the genetic makeup of tumors that might be responsible for their malignant behavior such as uncontrolled growth and spread. Some of these changes can be 'druggable', i.e. there may be cancer medicines that can specifically act on the tumour's genetic abnormality. Several cancer centers and programs have initiated this type of molecular profiling across Canada, with the goal to identify 'druggable' changes in tumors and find matching therapy for patients. These include initiatives in British Columbia, Ontario and Quebec. The CAnadian Profiling and Targeted agent Utilization tRial (CAPTUR) will test the activity of a list of commercially available targeted agents in patients who have undergone tumor profiling and have 'druggable' changes identified in their cancers.

    Canadian Profiling and Targeted agent Utilization tRial (CAPTUR). A Phase II Basket Trial.

    Complexity Level: 1

    Eligibility: Patients with incurable metastatic solid tumors, multiple myeloma, or B cell non-Hodgkin lymphoma (NHL - excluding CLL, SLL and HCL), who have no standard treatment options known to prolong life (or may have refused such option(s)), and have an "actionable" genomic variant known to be a target of a Health Canada-approved anticancer drug or to predict sensitivity to a Health Canada- approved anticancer drug.

    Objectives: PRIMARY: To evaluate the objective response rate (based on disease-appropriate objective criteria) of targeted drugs matched to pre-specified molecular aberrations (at the level of the gene) within a tumor type, among patients with incurable metastatic solid tumors, multiple myeloma, or B cell non-Hodgkin lymphoma (NHL) with an "actionable" genomic variant known to be a target of a Health Canada-approved anticancer drug or to predict sensitivity to a Health Canada- approved anticancer drug. SECONDARY: (1) To evaluate the safety of commercially available anticancer agents in patients enrolled on CAPTUR; (2) To evaluate progression free survival (PFS) based on disease-appropriate objective criteria.

    NCT Registration ID (from clinicaltrials.gov): NCT03297606
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Open to Accrual
    Activation Date: October 06, 2017



    		Open to Accrual
    PM2

    Canadian Initiative to Measure, Predict and Assess Cancer Treatment Outcomes in Patients Treated with Immuno-Oncotherapeutics (CAN-IMPACT-IO)

    The MOHCCN is a national network of Canadian cancer centres that pursues collaborative cancer research in precision medicine (an emerging approach for disease treatment and prevention that considers individual variability in genetic makeup, environment, and lifestyle) to accelerate the discovery of innovations and improve the health outcomes for cancer patients. This network will bring together individual precision medicine projects throughout Canada to ultimately enable clinicians and researchers to predict which treatment strategy will work for which specific patient more accurately. The purpose of this study is to use evolving technologies such as genomics and artificial intelligence to study cancer, so that the right treatment can be given to the right patient, at the right time. Approximately 15,000 participants will take part in this study across Canada in the first 6 years, and the goal is to enroll up to 100,000 over next 10 years. A description of this research study is available at https://www.marathonofhopecancercentres.ca This website will not include information that can identify you as an individual, if you choose to participate. The researchers are interested in examining the genome and transcriptome (DNA and RNA) found in your blood cells and tumour. The study of DNA, RNA and other molecules is often called genomics, transcriptomics and/or multiomics research. Changes in the genome and transcriptome of your tumour before, during and/or post-treatment affect how your body responds to treatment. This study is being done to enable collection and characterization of these samples. The results will be correlated with clinical outcomes of patients with your type of cancer receiving immunotherapy.

    Canadian Initiative to Measure, Predict and Assess Cancer Treatment Outcomes in Patients Treated with Immuno-Oncotherapeutics (CAN-IMPACT-IO)

    Complexity Level: 2

    Eligibility: CAN-IMPACT-IO is a standalone study of the CCTG, to be performed in collaboration with the Marathon of Hope Cancer Centres Network (MOHCCN) and Princess Margaret Cancer Consortium (PM2C), to perform fresh tumor biopsies for whole genome and transcriptome sequencing (WGTS) analysis for patients enrolled in a specified list of immuno-oncology (IO) therapeutic trials with immune checkpoint inhibitors targeting PD1/PDL1 as single agents or in combination currently active in CCTG.

    Objectives: Primary Objective -To profile human bodily material (HBM) from patients treated in a specified list of IO therapeutic trials currently active in CCTG, using WGTS either before treatment, during treatment or at time of disease progression with IO to uncover prognostic biomarkers as well as predictive biomarkers of response or resistance. Secondary Objectives -To contribute clinically annotated WGTS data to a unique MOHCCN cohort of 15,000 Canadian cancer patients via PM2C-led Pan-Canadian projects. Tertiary Objectives -To evaluate immune cell populations present in tumoral areas and in the tumor microenvironment (TME) using multiplexed immunohistochemistry (IHC) in a subset of patients treated in a specified list of IO therapeutic trials currently active in CCTG.

    NCT Registration ID (from clinicaltrials.gov): NCT06630273
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: CCTG Led Trial
    Status: Open to Accrual
    Activation Date: October 08, 2024



    		Open to Accrual
    PM1S

    Insight of the Use and Value of Genomic Analysis in Cancer Patients: A Pan-Canadian Survey of Oncologists and Patients


    Insight of the Use and Value of Genomic Analysis in Cancer Patients: A Pan-Canadian Survey of Oncologists and Patients

    Complexity Level: 3

    Eligibility: Patients with incurable metastatic solid tumors, multiple myeloma, or B cell non-Hodgkin lymphoma (NHL - excluding CLL, SLL and HCL), who have no standard treatment options known to prolong life (or may have refused such option(s)), and will haveundergone standard testing as indicated by local/provincial practice for diagnosis Medical oncologists must be QIs or SIs active on the PM.1 Participants List and must be from a site which is participating on the PM.1/CAPTUR trial..

    Objectives: Primary Objective 1. To determine how Canadian oncologists, from academic cancer centres, use Next-Generation Sequencing (NGS) tests to evaluate patients with metastatic disease who have already undergone standard of care diagnostic testing and inform treatment recommendations, pre- and post-testing. Secondary Objectives 1. To determine patient's satisfaction with their decision-making using a validated tool, pre- and post-NGS testing 2. To obtain feedback from oncologists on the decision impact of NGS and requirements to increase the usage of precision medicine

    NCT Registration ID (from clinicaltrials.gov): no NCT
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: CCTG Led Trial
    Status: Closed to Accrual
    Activation Date: June 08, 2020 Closing Date: May 31, 2022



    		Closed to Accrual

    Sarcoma

    IDStudy TitleStatus
    SR8

    NeoAdjuvant-only or Peri-operative cemiplimab in high-grade localised soft-tissue SARcoma (NAPStAR)


    NeoAdjuvant-only or Peri-operative cemiplimab in high-grade localised soft-tissue SARcoma (NAPStAR)

    Complexity Level: 2

    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: CCTG Led Trial
    Status: Planned



    		Planned
    SR7 (EORTC 1809-STBSG)

    A Randomized Phase III Study of Neoadjuvant Chemotherapy Followed by Surgery versus Surgery Alone for Patients with High Risk RetroPeritoneal Sarcoma (STRASS 2)

    This is a randomized, multicentre, open-label phase III trial of neoadjuvant chemotherapy followed by surgery versus surgery alone in patients with RPS. The randomization will be stratified by institution and histology: liposarcoma LPS or leyomiosarcoma (LMS). Patients will be randomized to either Standard arm: large en-bloc curative intent surgery or Experimental arm: 3 cycles of neoadjuvant chemotherapy followed by curative intent surgery. The primary endpoint of the study is disease free survival which includes as events: distant progression on neoadjuvant treatment, local progression if not followed by R0/R1 surgery, non-operable tumours, local recurrence and/or distant metastases, R2 and death.

    A Randomized Phase III Study of Neoadjuvant Chemotherapy Followed by Surgery versus Surgery Alone for Patients with High Risk RetroPeritoneal Sarcoma (STRASS 2)

    Complexity Level: 2

    Eligibility: Histologically proven primary high risk leiomyosarcoma (LMS) or Liposarcoma (LPS) of retroperitoneal space or infra-peritoneal spaces of pelvis, unifocal resectable tumour, radiologically measurable disease (RECIST 1.1), 18 years old or older, WHO ps 0-2, adequate haematological and organ function, ASA < 3, negative serum pregnancy test, consent to use highly effective birth control measures throughout duration of study and for at least 6 months after last treatment. No sarcoma originating from bone structure, abdominal or gynecological viscera, no metastatic disease, no previous treatment to present tumour, no hypersensitivity to doxorubicin, ifosfamide, dacarbazine or any of their metabolites/excipients, no recent or uncontrolled cardiac disease, no active or uncontrolled infections, and/or no live vaccines within 30 days of study entry.

    Objectives: The primary objective of this study is to assess whether preoperative chemotherapy, as an adjunct to curative-intent surgery, improves the prognosis of patients with high risk de-differentiated liposarcoma (DDLPS) and leiomyosarcoma (LMS) as measured by disease-free survival.

    NCT Registration ID (from clinicaltrials.gov): NCT04031677
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Open to Accrual
    Activation Date: February 01, 2021



    		Open to Accrual
    SRC8 (ECOG-ACRIN EA7222)

    A Randomized Phase III Trial of Doxorubicin + Pembrolizumab versus Doxorubicin Alone for the Treatment of Undifferentiated Pleomorphic Sarcoma (UPS) and Related Poorly Differentiated Sarcomas

    This Phase III randomized study aims to assess if doxorubicin plus pembrolizumab improves progression free survival compared to doxorubicin alone in anthracycline-naïve Undifferentiated Pleomorphic Sarcoma (UPS) patients.

    A Randomized Phase III Trial of Doxorubicin + Pembrolizumab versus Doxorubicin Alone for the Treatment of Undifferentiated Pleomorphic Sarcoma (UPS) and Related Poorly Differentiated Sarcomas

    Complexity Level: 2

    Eligibility: Patient must be ≥ 18 years of age. Must have a confirmed histopathologic diagnosis of Undifferentiated Pleomorphic Sarcoma (UPS) or a related poorly differentiated sarcoma. must have metastatic or unresectable sarcoma. Patient must have an ECOG Performance Status 0-1.

    Objectives: PRIMARY:To assess whether the combination of doxorubicin and pembrolizumab will improve progression free survival (PFS) in UPS and related poorly differentiated sarcomas relative to doxorubicin alone. SECONDARY:To assess whether the combination of doxorubicin and pembrolizumab vs the re-introduction of pembrolizumab in the doxorubicin alone arm at disease progression (i.e., upfront pembrolizumab vs second line pembrolizumab) improves overall survival (OS). -To evaluate the safety and tolerability in each treatment arm -To quantify overall response rate (ORR) and durability of response (DOR) in each treatment.

    NCT Registration ID (from clinicaltrials.gov): NCT06422806
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Open to Accrual
    Activation Date: November 21, 2024



    		Open to Accrual
    SRC6 (COG ARST1321)

    Pazopanib Neoadjuvant Trial in Non-Rhabdomyosarcoma Soft Tissue Sarcomas (PAZNTIS): A Phase II/III Randomized Trial of Preoperative Chemoradiation or Preoperative Radiation Plus or Minus Pazopanib


    Pazopanib Neoadjuvant Trial in Non-Rhabdomyosarcoma Soft Tissue Sarcomas (PAZNTIS): A Phase II/III Randomized Trial of Preoperative Chemoradiation or Preoperative Radiation Plus or Minus Pazopanib

    Complexity Level: 2

    Eligibility: Newly diagnosed and histopathologically confirmed, potentially resectable NRSTS of the extremity and trunk. Patients must be 2 years or older at the time of the biopsy that established the diagnosis of NRSTS.

    Objectives: Primary:Determine feasibility of pazopanib + radiation or chemoradiation (phase II. Compare rates of complete pathologic response in patients receiving radiation or chemoradiation +/- pazopanib (phase II).Compare rates of EFS in patients receiving radiation +/- pazopanib (phase III) Secondary: Estimate and compare rates of local, regional and distant failure, DFS and OS. Compare patterns of recurrence. Define toxicities of pazopanib in combination with radiation or chemoradiation.

    NCT Registration ID (from clinicaltrials.gov): NCT02180867
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: December 05, 2014 Closing Date: October 22, 2018



    		Closed to Accrual
    SRC7 (ALLIANCE A091105)

    A Phase III, Double Blind, Randomized, Placebo-Controlled Trial of Sorafenib in Desmoid Tumors or Aggressive Fibromatosis (DT/DF)


    A Phase III, Double Blind, Randomized, Placebo-Controlled Trial of Sorafenib in Desmoid Tumors or Aggressive Fibromatosis (DT/DF)

    Complexity Level: 2

    Eligibility: Patients must have confirmation of DT/DF by local pathologist prior to registration. Prior therapies must have been completed at least 4 weeks prior to registration. No prior treatment with sorafenib. No concomitant treatment, in therapeutic doses, with or antiplatelet agents, or with CYP3A4 inhibitors. Patients must have measurable disease and either have unresectable disese, disease progression by radiographic imaging, or symptomatic disease which is BPI score greater than or equal to 3 and unable to control pain with NSAIDs, OR >30% increase in current use of narcotics OR addition of a new opioid narcotic. Patient must be 18 years of age or older, ECOG PS less than or equal to 2, not pregnant or nursing, no history of cardiac disease, no inadequately controlled hypertension, prior history of hypertensive crisis or hypertensive encephalopathy, no clinically significant GI bleeding or bleeding diathesis within 30 days of registration, and adequate blood counts.

    Objectives: Primary Objective: To compare the progression-free survival (PFS) rates of patients with DT/DF who receive either sorafenib or placebo using a double-blinded randomized phase III study. Secondary Objectives: To assess toxicity, to assess time to surgical intervention, to assess tumor response rates and survival.

    NCT Registration ID (from clinicaltrials.gov): NCT02066181
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: July 17, 2015 Closing Date: December 01, 2016



    		Permanently Closed
    SR3 (EORTC 62931)

    Randomized Trial of Adjuvant Chemotherapy with High-dose Doxorubicin, Ifosfamide and Lenograstim (G-CSF) in High Grade Soft Tissue Sarcoma


    Randomized Trial of Adjuvant Chemotherapy with High-dose Doxorubicin, Ifosfamide and Lenograstim (G-CSF) in High Grade Soft Tissue Sarcoma

    Complexity Level: 2

    Eligibility: Patients with histologically proven high grade soft tissue sarcoma (grade II or III) with no evidence of metastases.

    Objectives: To compare the effect of treatment with ifosfamide and high dose doxorubicin with filgrastim versus observation on overall survival and relapse free survival.

    NCT Registration ID (from clinicaltrials.gov): NCT00002641
    Participation: Not limited
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: October 05, 1999 Closing Date: December 15, 2003



    		Permanently Closed
    SR1 (E62874)

    A Randomized Phase II/III Study of Neoadjuvant Chemotherapy In Soft Tissue Sarcomas in Adults


    A Randomized Phase II/III Study of Neoadjuvant Chemotherapy In Soft Tissue Sarcomas in Adults

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: September 12, 1989 Closing Date: February 01, 1994



    		Permanently Closed
    SR6 (TH-CR-406 / SARC021)

    A Randomized Phase 3, Multicenter, Open-Label Study Comparing TH-302 in Combination with Doxorubicin vs. Doxorubicin Alone in Subjects with Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma


    A Randomized Phase 3, Multicenter, Open-Label Study Comparing TH-302 in Combination with Doxorubicin vs. Doxorubicin Alone in Subjects with Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma

    Complexity Level: 2

    Eligibility: Male or female 15 years of age or older, has provided informed consent to participate, has pathologically confirmed diagnosis of soft tissue sarcoma for which doxorubicin is appropriate single agent therapy (see main protocol for details), disease is locally advanced unresectable or metastatic with no standard curative therapy available, measurable disease by RECIST 1.1 criteria, ECOG PS of 0 or 1, recovered from prior therapy, life expectancy of at least 3 months, acceptable blood test results for liver, renal and bone marrow function, acceptable cardiac function, must agree to use contraception.

    Objectives: PRIMARY OBJECTIVES: To evaluate the efficacy and safety of TH-302 in combination with doxorubicin as determined by overall survival in subjects with locally advanced unresectable or metastatic soft tissue sarcoma previously untreated with chemotherapy (neoadjuvant and adjuvant chemotherapy permitted) compared with doxorubicin alone. SECONDARY OBJECTIVES: To evaluate the efficacy of TH-302 in combination with doxorubicin as determined by progression-free survival and response rate in subjects; to investigate the pharmacokinetics of TH-302, Br-IPM, doxorubicin and doxorubicinol in plasma. TERTIARY OBJECTIVES: to evaluate the efficacy of TH-302 in combination with doxorubicin as determined by overall survival at 6 and 12 months, progression free rate at 3 and 6 months, duration of response, stable disease or better rate, change in ECOG and performance status; to explore and compare quality of life and derive health state utilities.

    NCT Registration ID (from clinicaltrials.gov): NCT01440088
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: July 20, 2012 Closing Date: December 26, 2013



    		Permanently Closed
    SR4 (SWOG S0033)

    Phase III Randomized, Intergroup Trial Assessing the Clinical Activity of STI-571 at Two Dose Levels in Patients with Unresectable or Metastatic Gastrointestinal Stromal Tumors (GIST) Expressing the KIT Receptor Tyrosine Kinase (CD117)


    Phase III Randomized, Intergroup Trial Assessing the Clinical Activity of STI-571 at Two Dose Levels in Patients with Unresectable or Metastatic Gastrointestinal Stromal Tumors (GIST) Expressing the KIT Receptor Tyrosine Kinase (CD117)

    Complexity Level: 2

    Eligibility: Patients must have a biopsy proven diagnosis of gastrointestinal stromal tumour (GIST) which is distantly metastatic or unresectable. The primary must be of visceral or intraabdominal origin. All patients must have immunohistochemical documentation of KIT (CD117) expression by tumour documented by DAKO antibody staining. Patients must have an identified team (including a medical oncologist and a surgeon) to provide care.

    Objectives: To compare overall and progression-free survival for patients with unresectable or metastatic gastrointestinal stromal tumours (GIST) expressing KIT (CD 117) treated with low dose STI-571 versus high dose STI-571. To assess response rates (confirmed, unconfirmed, complete and partial) and toxicities of patients treated with these two doses of STI-571. To obtain tissue and blood samples from GIST patients before and following treatment with STI-571 for future correlative studies.

    NCT Registration ID (from clinicaltrials.gov): NCT00009906
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: January 10, 2001 Closing Date: September 01, 2001



    		Permanently Closed
    SRC5 (S0502)

    A Phase III Randomized Study of Imatinib, with or without Bevacizumab (NSC-704865), in Patients with Metastatic or Unresectable Gastrointestinal Stromal Tumours


    A Phase III Randomized Study of Imatinib, with or without Bevacizumab (NSC-704865), in Patients with Metastatic or Unresectable Gastrointestinal Stromal Tumours

    Eligibility: Patient must have a biopsy proven diagnosis of gastrointestinal stromal tumor (GIST) that is distantly metastatic or unresectable. Patients must be determined to be unresectable for cure.

    Objectives: Progression free survival; Economic; Correlative Biology.

    NCT Registration ID (from clinicaltrials.gov): NCT00324987
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: April 15, 2009 Closing Date: September 17, 2009



    		Permanently Closed
    OS2

    The Evaluation of Cis-platinum II, Dimminedi-chloroplatinum (DDP) (NSC - 119875) in Patients With Osteosarcoma Unresponsive to Adriamycin and High-Dose Methotrexate


    The Evaluation of Cis-platinum II, Dimminedi-chloroplatinum (DDP) (NSC - 119875) in Patients With Osteosarcoma Unresponsive to Adriamycin and High-Dose Methotrexate

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 10, 1978 Closing Date: May 01, 1980



    		Permanently Closed
    OS4 (80861)

    A Randomized Trial of Two Chemotherapy Regimens in the Treatment of Operable Osteosarcoma - Doxorubicin-Cisplatin vs Methotrexate-Vincristine-Doxorubicin + Doxorubicin-Cisplatin + Bleomycin-Cyclophosphamide-Dactinomycin


    A Randomized Trial of Two Chemotherapy Regimens in the Treatment of Operable Osteosarcoma - Doxorubicin-Cisplatin vs Methotrexate-Vincristine-Doxorubicin + Doxorubicin-Cisplatin + Bleomycin-Cyclophosphamide-Dactinomycin

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: September 02, 1986 Closing Date: March 15, 1993



    		Permanently Closed
    OS1

    NCIC Osteosarcoma. A Protocol for Clinical Investigation


    NCIC Osteosarcoma. A Protocol for Clinical Investigation

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: March 23, 1976 Closing Date: November 11, 1980



    		Permanently Closed
    SR5 (62012)

    Randomized Trial of Single Agent Doxorubicin Vs. Doxorubicin plus Ifosfamide in First Line Treatment of Advanced or Metastatic Soft Tissue Sarcoma


    Randomized Trial of Single Agent Doxorubicin Vs. Doxorubicin plus Ifosfamide in First Line Treatment of Advanced or Metastatic Soft Tissue Sarcoma

    Complexity Level: 2

    Eligibility: Patients with advanced or metastatic soft tissue sarcoma (FNLCC grades 2-3) with RECIST measurable lesions and at least 6 months since adjuvant chemotherapy and PS < 1 (WHO).

    Objectives: Overall survival; Response, toxicity and treatment related mortality.

    NCT Registration ID (from clinicaltrials.gov): NCT00061984
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: July 03, 2007 Closing Date: May 11, 2010



    		Permanently Closed
    SR2

    A Phase III Study of Pre-Operative External Beam Radiotherapy Compared to Post-Operative External Beam Radiotherapy in the Local Management of Curable Extremity Soft Tissue Sarcoma


    A Phase III Study of Pre-Operative External Beam Radiotherapy Compared to Post-Operative External Beam Radiotherapy in the Local Management of Curable Extremity Soft Tissue Sarcoma

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: September 21, 1994 Closing Date: December 12, 1997



    		Permanently Closed
    SRC1 (ACOSOG Z9001)

    A Phase III Randomized Double-Blind Study of Adjuvant STI571 (Gleevec) Versus Placebo in Patients Following the Resection of Primary Gastrointestinal Stromal Tumors (GIST)


    A Phase III Randomized Double-Blind Study of Adjuvant STI571 (Gleevec) Versus Placebo in Patients Following the Resection of Primary Gastrointestinal Stromal Tumors (GIST)

    Complexity Level: 2

    Eligibility: Patient must have a diagnosis of primary GIST confirmed histologially by central pathology review. The patient's tumor must stain positive for the Kit receptor tyrosine kinase on immunohistochemistry as determined by the Central Pathologist using the Dako anti-CD 117 antibody (Dako Corp., Carpinteria, CA). The patient must have undergone complete gross resection (includes R0 [negative microscopic margins] and R1 [positive microscopic margins] resections) of a primary GIST within 70 days prior to registration. Tumor size must be > 3 cm in maximum dimension. Post-operative chemotherapy, radiation therapy or investigational treatment will cause the patient to be ineligible, as will prior therapy with STI-571. Patients will not be eligible for randomization if they have New York Heart Association Class 3 or 4 cardiac disease, or if they are taking full-dose warfarin.

    Objectives: To ascertain whether patients with resected primary GIST who are randomized to the STI571 Arm have longer recurrence-free survival and overall survival as compared to the patients randomized to the Placebo Arm. To obtain from patients with GIST: tumor tissue (before therapy with STI571 and if the patient develops recurrence), blood specimens (before therapy with STI571), and serum specimens (before therapy with STI571, after completing therapy with STI571, and if the patient develops recurrence) for scientific correlative analyses. To assess the safety/efficacy of oral STI571 therapy in the adjuvant setting.

    NCT Registration ID (from clinicaltrials.gov): NCT00041197
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: October 04, 2002 Closing Date: April 18, 2007



    		Permanently Closed

    Symptom Control

    IDStudy TitleStatus
    SC31 (SC.31)

    Using SMART to optimize the stepped care delivery of TEMPO – a Tailored, dyadic, wEb-based physical activity and self-Management PrOgram for men with prostate cancer and their caregivers (TEMPO)


    Using SMART to optimize the stepped care delivery of TEMPO – a Tailored, dyadic, wEb-based physical activity and self-Management PrOgram for men with prostate cancer and their caregivers (TEMPO)

    Complexity Level: 3

    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Planned



    		Planned
    SC30 (TRU-RLS-21)

    Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy Platform Trial - RATIONAL-PT


    Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy Platform Trial - RATIONAL-PT

    Complexity Level: 3

    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Planned



    		Planned
    SC29

    A Randomized Phase III Study Comparing Stereotactic Body Radiotherapy (SBRT) versus Conventional Palliative Radiotherapy (CRT) for Participants with Painful Non-Spine Bone Metastases

    To detemine if staeotactic body radiation therapy is better at reducing bone metastses pain compared to conventional radiation therapy.

    A Randomized Phase III Study Comparing Stereotactic Body Radiotherapy (SBRT) versus Conventional Palliative Radiotherapy (CRT) for Participants with Painful Non-Spine Bone Metastases

    Complexity Level: 2

    Eligibility: Histologic confirmation of cancer Patient with a dominant painful non-spine bone metastasis and a worst minimum pain score of 2 using the ESAS attributed to the dominant site. Suitable for protocol defined SBRT and EBRT

    Objectives: The primary objective is to compare conventional EBRT to SBRT for 3-month complete pain response (CPR) administered to the dominant site of pain using the pain score question from the ESAS instrument and analgesic intake as recommended by the ICPRE

    NCT Registration ID (from clinicaltrials.gov): NCT06391242
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: CCTG Led Trial
    Status: Open to Accrual
    Activation Date: June 26, 2024



    		Open to Accrual
    SC28

    The SEAMLESS Study: A Pragmatic Multi-Site Randomized Waitlist-Controlled Trial of a Smartphone App-Based Mindfulness Intervention for French and English Speaker Cancer Survivors

    This study is being done to answer the following question: Can a mindfulness program (Mindfulness Based Cancer Survivorship (MBCS) Journey) delivered through a mobile smartphone application (app) (Am Mindfulness) reduce symptoms such as stress, anxiety, depression, and fatigue. These symptoms fall into the category of psychosocial symptoms and are often experienced by cancer survivors.

    The SEAMLESS Study: A Pragmatic Multi-Site Randomized Waitlist-Controlled Trial of a Smartphone App-Based Mindfulness Intervention for French and English Speaker Cancer Survivors

    Complexity Level: 3

    Eligibility: • Adult ≥ 18 years • Diagnosed with any type of cancer (stages I-IV) • Completed primary treatment (i.e. surgery, chemotherapy, radiation therapy) at least 2 weeks (14days) prior. Note: ongoing maintenance therapy, hormone-blocking therapies, intermittent bone-modifying agents, herceptin and targeted therapy with trastuzumab are not exclusionary

    Objectives: • Evaluate the effectiveness of the 4-week MBCS Journey intervention in decreasing total symptoms of stress in adult PLWC at 3 months from randomization • • Determine the impact of the 4-week MBCS Journey intervention on anxiety, depression, fatigue, and overall physical functioning and quality of life in adult PLWC post-treatment, immediately after the therapeutic intervention

    NCT Registration ID (from clinicaltrials.gov): NCT05470010
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: CCTG Led Trial
    Status: Open to Accrual
    Activation Date: August 29, 2023



    		Open to Accrual
    SC26

    Emotion and Symptom-focused Engagement (EASE): A Multi-Site Randomized Controlled Trial of an Intervention for Individuals with Acute Leukemia

    Leukemia is the 6th most common cause of cancer death in Canada, with adult acute leukemia (AL) being the most fatal form. Despite the rapid onset and life-threatening nature of AL and its treatment, little research on its psychological and physical effects and the interventions to reduce them have been done. Preliminary evidence has showed that an integrated psychosocial and early palliative intervention (e.g. EASE) reduces physical and psychological distress as compared to usual care (UC).This large, unblended phase 3 randomized controlled trial of EASE vs. UC will tests its effectiveness in reducing and preventing psychological and physical distress in adults with newly-diagnosed or relapsed AL.

    Emotion and Symptom-focused Engagement (EASE): A Multi-Site Randomized Controlled Trial of an Intervention for Individuals with Acute Leukemia

    Complexity Level: 2

    Eligibility: Patients with newly-diagnosed acute leukemia (AL) within 2 weeks of admission who will be receiving induction chemotherapy with curative intent. Patients must be fluent in English and must pass the cognitive screening test.

    Objectives: PRIMARY OBJECTIVE: To determine the effectiveness of EASE vs. usual care (UC) to reduce psychological distress and physical symptom severity in adults with newly diagnosed acute leukemia after 8 weeks of implementation. SECONDARY OBJECTIVE: (1) To determine the effectiveness of EASE vs. UC to reduce psychological distress and physical symptom severity after 4 and 12 weeks, 6 months, and 1 year; (2) to determine the effects of EASE vs UC on other domains of health-related quality of life; and (3) to conduct post-trial, an economic analysis of EASE to determine the cost-effectiveness of EASE delivery in relation to its effect on reduction of distress in individuals with AL compared to UC.

    NCT Registration ID (from clinicaltrials.gov): NCT04224974
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: CCTG Led Trial
    Status: Open to Accrual
    Activation Date: December 23, 2019



    		Open to Accrual
    ICC1 (NCICOVID)

    NCI COVID-19 in Cancer Patients Study (N-CCaPS): A Longitudinal Natural History Study


    NCI COVID-19 in Cancer Patients Study (N-CCaPS): A Longitudinal Natural History Study

    Complexity Level: 3

    Eligibility: Patients must have a prior or current cancer diagnosis, that fits into one of the following categories: - Patient is receiving active treatment (current or within the last 6 weeks) for metastatic cancer - Patient is receiving adjuvant treatment + had IV chemotherapy, immuno or targeted therapy, endocrine therapy, or RT in the last 6 weeks - Patient received ASCT, CAR-T or modified cell therapy at any time - Patient is receiving treatment or prophylaxis or host disease, or received bone marrow transplant within the past 2 years. Patients must have had a positive COVID-19 test within the last 14 days using any specimen source. Patients with brain mets or HIV are eligible. Co-enrollment on other clinical trials is allowed.

    Objectives: 1. Characterize patient factors, such as pre-existing comorbidities, cancer type and treatment, and demographic factors, associated with short- and long-term outcomes of COVID-19, including severity and fatality, in cancer patients undergoing treatment. 2. Describe cancer treatment modifications made in response to COVID-19, including dose adjustments, changes in symptom management, or temporary or permanent cessation. 3. Evaluate the association of COVID-19 with cancer outcomes in patient subgroups defined by clinico-pathologic characteristics. 4. Correlative study objectives by collection, storage, and research of blood specimens and radiological images.

    NCT Registration ID (from clinicaltrials.gov): NCT04387656
    Participation: Open to member centres
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Closed to Accrual
    Activation Date: June 18, 2020 Closing Date: February 01, 2022



    		Closed to Accrual
    IC8

    COV-IMMUNO - A Randomized, Phase III Trial of Immunization with IMM-101 versus Observation for the Prevention of Severe Respiratory and COVID-19 Related Infections in Cancer Patients at Increased Risk of Exposure


    COV-IMMUNO - A Randomized, Phase III Trial of Immunization with IMM-101 versus Observation for the Prevention of Severe Respiratory and COVID-19 Related Infections in Cancer Patients at Increased Risk of Exposure

    Complexity Level: 2

    Eligibility: Patients must be: -undergoing (or be planned to undergo) active treatment for one or more solid malignancy, lymphoma or myeloma, requiring them to present to the hospital or cancer clinic at least twice/month for assessments and/or treatments, anticipated for at least 3 months. - have one or more of the following risk factors for a severe COVID-19 infection: Age > 65 years old; Hypertension (on medications); Type 1 or 2 Diabetes (on medication); A relevant chronic condition as per the investigator based on the medical record including heart, lung, liver and/or serious kidney disease; receiving systemic therapy; Body Mass Index > 40; Living in a nursing home or long term care facility. - Age 18 or greater and an ECOG PS of 0-2

    Objectives: Primary objective: to investigate the effectiveness of IMM 101 at preventing "influenza-like illnesses" (ILI), as defined by the WHO, OR a confirmed viral/bacterial respiratory infection (via microbiology or radiography), AND that results in a change or delay in a priori planned cancer treatment or requirement for an unscheduled medical assessment (i.e. emergency room visit, family physician assessment, etc.), hospitalization, or death compared to control subjects. Numerous Secondary and Tertiary/Exploratory Objectives planned.

    NCT Registration ID (from clinicaltrials.gov): NCT04442048
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: CCTG Led Trial
    Status: Closed to Accrual
    Activation Date: June 25, 2020 Closing Date: May 14, 2021



    		Closed to Accrual
    SC27

    Living with Cancer in the Time of COVID-19: A Cohort Study of the Impact of the COVID-19 Pandemic on Cancer Patients During Treatment and Survivors


    Living with Cancer in the Time of COVID-19: A Cohort Study of the Impact of the COVID-19 Pandemic on Cancer Patients During Treatment and Survivors

    Complexity Level: 3

    Eligibility: >=18 years of age: any cancer diagnosis in the last 10 years, any stage; must be able to read/ write english or french

    Objectives: Primary objectives 1. Describe the pattern of psychosocial and physical symptom severity, and QOL over time and differences by sub-groups (e.g., age, gender, cancer stage) 2. Assess participants' perceptions of their experience and satisfaction of cancer care over time 3. Identify the coping strategies, and health and safety actions used by patients and survivors during cancer diagnosis, treatment, and recovery in the context of COVID-19 Secondary objectives 4. Examine factors associated with psychosocial and physical symptom severity, poor QOL and other clinical outcomes (e.g., COVID-19 status, hospitalization, and mortality). 4a. Explore effect modification by selected subgroups (e.g., age, sex, gender, cancer stage)

    NCT Registration ID (from clinicaltrials.gov): no NCT
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: CCTG Led Trial
    Status: Closed to Accrual
    Activation Date: June 30, 2020 Closing Date: August 16, 2022



    		Closed to Accrual
    IC1

    A Study of the Efficacy of Lethium in Preventing Infections in Patients With Acute Leukemia


    A Study of the Efficacy of Lethium in Preventing Infections in Patients With Acute Leukemia

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: December 01, 1979 Closing Date: June 01, 1982



    		Permanently Closed
    IC6 (46852)

    Empiric Antibiotic Therapy for Infection in Febrile Granulocytopenic Patients. A Prospective, Randomised Evaluation of Ceftazidime Plus Amikacin versus Ceftazidime Plus Amikacin Plus Vancomycin


    Empiric Antibiotic Therapy for Infection in Febrile Granulocytopenic Patients. A Prospective, Randomised Evaluation of Ceftazidime Plus Amikacin versus Ceftazidime Plus Amikacin Plus Vancomycin

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: July 01, 1986 Closing Date: December 21, 1987



    		Permanently Closed
    SC6

    An Assessment of the Antiemetic Efficacy, Tolerance, and Safety of GR38032f versus Dexamethasone Plus Metoclopramide in Patients With Breast Cancer Receiving "CMF" Chemotherapy


    An Assessment of the Antiemetic Efficacy, Tolerance, and Safety of GR38032f versus Dexamethasone Plus Metoclopramide in Patients With Breast Cancer Receiving "CMF" Chemotherapy

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 20, 1989 Closing Date: November 02, 1990



    		Permanently Closed
    SC1

    A Comparison of Methylprednisolane Sodium Succinate and Metoclopramide Hydrochloride in the Prevention of Nausea and Vomiting Produced by Cancer Chemotherapy


    A Comparison of Methylprednisolane Sodium Succinate and Metoclopramide Hydrochloride in the Prevention of Nausea and Vomiting Produced by Cancer Chemotherapy

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: October 30, 1982 Closing Date: March 01, 1984



    		Permanently Closed
    SC5

    A Double Blind Assessment of the Antiemetic Efficacy, Tolerance and Safety of BRL 43694a in Comparison With Dexamethasone and Prochlorperazine in Patients Receiving Moderately Emetogenic Chemotherapy


    A Double Blind Assessment of the Antiemetic Efficacy, Tolerance and Safety of BRL 43694a in Comparison With Dexamethasone and Prochlorperazine in Patients Receiving Moderately Emetogenic Chemotherapy

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 08, 1988 Closing Date: March 03, 1989



    		Permanently Closed
    SC24

    A Randomized Phase II/III Study Comparing Stereotactic Body Radiotherapy(SBRT) versus Conventional Palliative Radiotherapy (CRT) for Patients with Spinal Metastases


    A Randomized Phase II/III Study Comparing Stereotactic Body Radiotherapy(SBRT) versus Conventional Palliative Radiotherapy (CRT) for Patients with Spinal Metastases

    Complexity Level: 1

    Eligibility: Patients with tumours (excluding seminoma, small cell lung cancer and metastases from hematologic malignancies) who have MRI-documented spinal metastases, suitable for receiving radiation therapy, and fulfill the following criteria: (a) Pain secondary to spinal metastases requiring treatment; (b) <=3 consecutive spinal segments involved by tumour to be included in the target volume

    Objectives: PRIMARY ENDPOINT: Phase II study: The ability to accrue 54 patients over an 18 month period to a study that randomizes patients with spinal metastases to Stereotactic Body Radiotherapy (SBRT) or Standard Conventional Radiotherapy (CRT) within a Canadian multicentre setting. Phase III study: To assess complete pain response in the treatment area at 3 months post-radiation. SECONDARY ENDPOINTS: (1) Complete pain response in the treatment area at 6 months post-radiation; (2) Radiation site progression-free survival (RSS PFS) at 3 and 6 months; (3) Spinal Instability Neoplastic Score at 3 and 6 months; (4) Overall Surivval; (5) Adverse event profile; (6) Healthe-related Quality of Life; (7) Economic Analysis; (8) Radiotherapy Quality Assurance (RTQA) compliance. TERTIARY ENDPOINTS: (1) Radiomics; (2) Biobanking for future correlative studies TERTIARY ENDPOINT: Biobanking for future correlative Studies.

    NCT Registration ID (from clinicaltrials.gov): NCT02512965
    Participation: Open to member centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: CCTG Led Trial
    Status: Permanently Closed
    Activation Date: July 28, 2015 Closing Date: September 27, 2019



    		Permanently Closed
    SC12

    A Phase III Study of an Assessment of the Efficacy of Dexamethasone in the Prophlaxis of Radiation Induced Emesis


    A Phase III Study of an Assessment of the Efficacy of Dexamethasone in the Prophlaxis of Radiation Induced Emesis

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: March 27, 1995 Closing Date: September 29, 1997



    		Permanently Closed
    SC20 (SC20)

    A Phase III International Randomized Trial of Single Versus Multiple Fractions for Re-Irradiation of Painful Bone Metastases


    A Phase III International Randomized Trial of Single Versus Multiple Fractions for Re-Irradiation of Painful Bone Metastases

    Complexity Level: 2

    Eligibility: Patients with painful bone metastases after previous palliative radiotherapy had been given to the diseased bone.

    Objectives: To assess the factors that influence response to re-irradiation and to determine the incidence of severe radiation side effects.

    NCT Registration ID (from clinicaltrials.gov): NCT00080912
    Participation: Not Limited.
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 07, 2004 Closing Date: May 24, 2012



    		Permanently Closed
    SC4

    A Double Blind Assessment of the Antiemetic Efficacy, Tolerance and Safety of BrL 43694a in Comparison With High Dose Metoclopromide, Dexamethasone and Diphenhydramine in Patients Receiving Highly Emetogenic Cisplatin Chemotherapy


    A Double Blind Assessment of the Antiemetic Efficacy, Tolerance and Safety of BrL 43694a in Comparison With High Dose Metoclopromide, Dexamethasone and Diphenhydramine in Patients Receiving Highly Emetogenic Cisplatin Chemotherapy

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 08, 1988 Closing Date: July 31, 1989



    		Permanently Closed
    SC2

    To Evaluate the Efficacy of Methylprednisone Acetate (Depo-Medrol) in Maintaining the Anti-nauseant Effect of Methylprednisone Sodium Succinate (Solu-Medrol) in the Prevention of Nausea and Vomiting Produced by Cancer Chemotherapy


    To Evaluate the Efficacy of Methylprednisone Acetate (Depo-Medrol) in Maintaining the Anti-nauseant Effect of Methylprednisone Sodium Succinate (Solu-Medrol) in the Prevention of Nausea and Vomiting Produced by Cancer Chemotherapy

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: March 01, 1985 Closing Date: October 06, 1986



    		Permanently Closed
    SC9

    An Assessment of the Effect of Schedule and Maintenance on the Antiemetic Efficacy and Safety of Ondansetron Combined With Dexamethasone as Acute and Maintenance Therapy in Patients Receiving Moderately Emetogenic Chemotherapy


    An Assessment of the Effect of Schedule and Maintenance on the Antiemetic Efficacy and Safety of Ondansetron Combined With Dexamethasone as Acute and Maintenance Therapy in Patients Receiving Moderately Emetogenic Chemotherapy

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: March 01, 1991 Closing Date: August 02, 1991



    		Permanently Closed
    SC10

    A Randomized Controlled Phase III Trial of Clodronate in the Treatment of Bone Pain Due to Metastatic Cancer


    A Randomized Controlled Phase III Trial of Clodronate in the Treatment of Bone Pain Due to Metastatic Cancer

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: March 27, 1992 Closing Date: January 31, 1994



    		Permanently Closed
    SC17

    A Phase III Double-Blind Equivalence Study of Two Different Formulations of Slow-Release Morphine Followed by a Randomization Between Dextromethorphan or Placebo Plus Statex Sr for Chronic Cancer Pain Relief in Terminally Ill Patients


    A Phase III Double-Blind Equivalence Study of Two Different Formulations of Slow-Release Morphine Followed by a Randomization Between Dextromethorphan or Placebo Plus Statex Sr for Chronic Cancer Pain Relief in Terminally Ill Patients

    Eligibility: Patients requiring morphine for the treatment of chronic cancer pain who have been managed by a stable dose of MS contin.

    Objectives: To compare the efficacy of statex SR with that of MS contin and to assess the analgesic potential of dextromethorphan with morphine SR.

    NCT Registration ID (from clinicaltrials.gov): NCT00003687
    Participation: Limited
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: June 11, 1998 Closing Date: July 23, 2001



    		Permanently Closed
    SC16

    A Double Blind Phase III Study of Oral Pilocarpine for Opioid-Induced Dry Mouth.


    A Double Blind Phase III Study of Oral Pilocarpine for Opioid-Induced Dry Mouth.

    NCT Registration ID (from clinicaltrials.gov): NCT00003686
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: May 22, 1998 Closing Date: November 08, 1999



    		Permanently Closed
    IC2

    Protocol for the Management of Febrile Granulocytopenic Patients. Tobramycin/Ticarillin versus Moxalactam/Ticarcillin as Initial Treatment for Febrile Granulocytopenic Patients


    Protocol for the Management of Febrile Granulocytopenic Patients. Tobramycin/Ticarillin versus Moxalactam/Ticarcillin as Initial Treatment for Febrile Granulocytopenic Patients

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: March 31, 1981 Closing Date: October 31, 1982



    		Permanently Closed
    SC11

    A Phase III Double-Blind Comparison of Dolasetron Mesylate With Ondansetron and an Evaluation of the Additive Role of Dexamethasone in the Prevention of Acute (IV) and Delayed (Oral) Emesis Due to Moderately Emetogenic Chemotherapy


    A Phase III Double-Blind Comparison of Dolasetron Mesylate With Ondansetron and an Evaluation of the Additive Role of Dexamethasone in the Prevention of Acute (IV) and Delayed (Oral) Emesis Due to Moderately Emetogenic Chemotherapy

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: May 05, 1993 Closing Date: January 27, 1995



    		Permanently Closed
    SC8

    A Double Blind Comparator Study for the Prophylactic Use of Granisetron Both Alone and in Combination With Dexamethasone Over a 7 Day Period in Controlling Nausea and Vomiting Associated With High Dose Cisplatin Therapy in Patients With Malignant Disease


    A Double Blind Comparator Study for the Prophylactic Use of Granisetron Both Alone and in Combination With Dexamethasone Over a 7 Day Period in Controlling Nausea and Vomiting Associated With High Dose Cisplatin Therapy in Patients With Malignant Disease

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: March 25, 1991 Closing Date: June 20, 1994



    		Permanently Closed
    SC18 (989255)

    Phase III Double-Blind, Placebo-Controlled Randomized Comparison of Megestrol Acetate (Megace) versus an N-3 Fatty Acid (EPA) Enriched Nutritional Supplement versus Both for the Treatment of Cancer Cachexia and Anorexia


    Phase III Double-Blind, Placebo-Controlled Randomized Comparison of Megestrol Acetate (Megace) versus an N-3 Fatty Acid (EPA) Enriched Nutritional Supplement versus Both for the Treatment of Cancer Cachexia and Anorexia

    Eligibility: Histologic or cytologic proven cancer other than brain, breast, ovarian, endometrial cancer or prostate cancer. If the patient has multiple primaries or an unknown primary, the currently active cancer cannot be known to be of brain, breast, ovarian, endometrial, or prostate cancer. Patient must be able to take oral medication reliably, and have a history of losing at least 5 pounds over the preceding two months or less.

    Objectives: To compare the appetite-stimulating properties of megestrol acetate versus an eicosapentaenoic acid-enriched supplement versus both for the treatment of cancer-related (and cancer treatment related) cachexia and anorexia by following patient weight, rate of weight change, and appetite. To evaluate the effect of these treatments on nausea and vomiting in patients with advanced metastatic disease.

    NCT Registration ID (from clinicaltrials.gov): NCT00031707
    Participation: Limited to centres with a current CPA #.
    NCI US Affiliation: Yes
    Clinical Trials Application (Canada): Yes
    Coordination: Intergroup Led Trial
    Status: Permanently Closed
    Activation Date: September 11, 2000 Closing Date: August 15, 2002



    		Permanently Closed
    SC14

    A Phase III Double Blind Study of Theophylline versus Placebo for the Treatment of Dyspnea in Cancer Patients


    A Phase III Double Blind Study of Theophylline versus Placebo for the Treatment of Dyspnea in Cancer Patients

    NCT Registration ID (from clinicaltrials.gov): NCT00003684
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: March 24, 1998 Closing Date: November 08, 1999



    		Permanently Closed
    SC20U (SC20U)

    A phase III study of the effect of re-irradiation for bone pain on urinary markers of osteoclast activity.


    A phase III study of the effect of re-irradiation for bone pain on urinary markers of osteoclast activity.

    Complexity Level: 2

    Eligibility: Patients with painful bone metasteses after previous palliative radiotherapy had been given to the diseased bone.

    Objectives: To correlate the response of re-irradiation to the change of urinary markers of osteoclast activity.

    NCT Registration ID (from clinicaltrials.gov): no NCT
    Participation: Patients randomized to SC.20 in selected centres in Canada and the United Kingdom.
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 06, 2004 Closing Date: May 24, 2012



    		Permanently Closed
    IC4

    Comparison of Azthreonam Plus Antistaphylococcal Therapy, Azthreonam Plus Aminoglycoside, or Moxalactam Plus Aminoglycoside for the Therapy of Febrile Neutropenic Episodes in Cancer Patients Undergoing Cytotoxic Chemotherapy


    Comparison of Azthreonam Plus Antistaphylococcal Therapy, Azthreonam Plus Aminoglycoside, or Moxalactam Plus Aminoglycoside for the Therapy of Febrile Neutropenic Episodes in Cancer Patients Undergoing Cytotoxic Chemotherapy

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: January 27, 1983 Closing Date: April 01, 1985



    		Permanently Closed
    SC19

    A Phase III Study of Ondansetron and Dexamethasone versus Ondansetron and Placebo in the Prophylaxis Against Radiation-induced Emesis


    A Phase III Study of Ondansetron and Dexamethasone versus Ondansetron and Placebo in the Prophylaxis Against Radiation-induced Emesis

    Eligibility: Patients at risk of developing radiation-induced emesis secondary to a fractionated course of radiotherapy consisting of at least 15 fractions to a field encompassing the upper abdomen.

    Objectives: To compare the effectiveness in complete protection from radiation-induced emesis and nausea using a 5-day regimen of prophylactic ondansetron and dexamethasone versus ondansetron and placebo. To compare the toxicity of the regimens and quality of life of patients in the two groups.

    NCT Registration ID (from clinicaltrials.gov): NCT00016380
    Participation: Not limited.
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: February 28, 2001 Closing Date: January 31, 2004



    		Permanently Closed
    SC15

    A Phase III Trial of Single versus Fractionated Thoracic Radiation for Palliation of Symptoms in Patientswith Non-Small Cell Lung Cancer


    A Phase III Trial of Single versus Fractionated Thoracic Radiation for Palliation of Symptoms in Patientswith Non-Small Cell Lung Cancer

    NCT Registration ID (from clinicaltrials.gov): NCT00003685
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: August 01, 1997 Closing Date: January 23, 2001



    		Permanently Closed
    SC7

    A Randomized Double-Blind Efficacy, Safety and Pharmacokinetic Study of Six Doses of the Antiemetic BMY-25801 and Methylprednisone Among Out-Patients Receiving Moderately Emetogenic Chemotherapy


    A Randomized Double-Blind Efficacy, Safety and Pharmacokinetic Study of Six Doses of the Antiemetic BMY-25801 and Methylprednisone Among Out-Patients Receiving Moderately Emetogenic Chemotherapy

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: February 14, 1989 Closing Date: February 16, 1990



    		Permanently Closed
    SC22

    A Phase I Study To Determine The Dose of Methadone As A First Line Agent In The Treatment of Chronic Neuropathic Cancer Pain.


    A Phase I Study To Determine The Dose of Methadone As A First Line Agent In The Treatment of Chronic Neuropathic Cancer Pain.

    Eligibility: Patients with chronic neuropathic cancer pain who need to be started on strong opioids or require an increase in their opioid dose and are currently taking opioids at a dose less than or equal to 75mg daily oral morphine equivalent.

    Objectives: To determine the optimum starting dose of methadone as a 'first line' opioid in the treatment of chronic neuropathic cancer pain. To assess parameters of pain control achieved with methadone as a 'first line' opioid in the treatment of chronic neuropathic cancer pain including: number and timing of BTA usage, number of episodes of breakthrough pain, total daily dose of methadone, average pain score. To determine the safety and adverse event profile of methadone as a 'first line' opioid in the treatment of chronic neuropathic cancer pain. To assess the frequency and severity of sleep disturbance associated with the use of methadone. To determine the feasibility of recruiting patients with chronic neuropathic cancer pain in a reasonable time frame for a future phase III study of methadone versus morphine.

    NCT Registration ID (from clinicaltrials.gov): NCT00930332
    Participation: Limited to Canadian centres with a physician licensed to prescribe methadone.
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: April 17, 2009 Closing Date: May 16, 2011



    		Permanently Closed
    IC7

    A Multicentric, Randomized Study to Evaluate the Safety and Efficacy of Ofloxacin versus Ofloxacin Plus Rifampin versus Norfloxacin in the Prevention of Fever and Sepsis in Patients Expected to Become Neutropenic


    A Multicentric, Randomized Study to Evaluate the Safety and Efficacy of Ofloxacin versus Ofloxacin Plus Rifampin versus Norfloxacin in the Prevention of Fever and Sepsis in Patients Expected to Become Neutropenic

    NCT Registration ID (from clinicaltrials.gov): no NCT
    NCI US Affiliation: No
    Clinical Trials Application (Canada): No
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: July 14, 1989 Closing Date: June 30, 1992



    		Permanently Closed
    SC23

    A Phase III Double-Blind Study of Dexamethasone Versus Placebo in the Prophylaxis of Radiation-Induced Pain Flare Following Palliative Radiotherapy for Bone Metastases.


    A Phase III Double-Blind Study of Dexamethasone Versus Placebo in the Prophylaxis of Radiation-Induced Pain Flare Following Palliative Radiotherapy for Bone Metastases.

    Complexity Level: 2

    Eligibility: Cancer patients requiring treatment with radiotherapy in a single fraction of 8 Gy for bone metastases in one or two painful areas.

    Objectives: - To compare the effectiveness of prophylactic dexamethasone versus placebo in protecting against radiation-induced pain flare associated with a single 8 Gy course of treatment by examining the difference in incidence of pain flare in the first 10 days after therapy. - To compare in patients treated with dexamethasone versus placebo: the incidences of pain flare occurring on Days 0-5 and Days 6-10; the nature, severity and frequencies of adverse events; and quality of life. - To validate the EORTC QLQ-BM22 module with the EORTC QLQ-C15-PAL. - To investigate if pain flare following palliative radiotherapy is correlated with a surge of inflammatory cytokines and baseline levels of the bone turnover markers pyridinoline and N-telopeptide. - To investigate if dexamethasone prophylaxis is mediated through a decrease in inflammatory cytokines and if prophylaxis failure is due to rapid metabolism of drug, intrinsic glucocorticoid recepter defects or variations in SNPs.

    NCT Registration ID (from clinicaltrials.gov): NCT01248585
    Participation: Limited to invited centres
    NCI US Affiliation: No
    Clinical Trials Application (Canada): Yes
    Coordination: NCIC CTG Led Trial
    Status: Permanently Closed
    Activation Date: November 22, 2010 Closing Date: December 12, 2014



    		Permanently Closed