All Disease Sites

Brain

ID	Study Title	Status
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. Read More 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
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. Read More 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
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 Read More 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 Read More 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 Read More 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. Read More 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
CE1	NCIC Cooperative Clinical Trial on Treatment of Cerebral Tumours (Glioblastomas) With Pre-Operative BCNU and Superfractionated Radiotherapy Read More 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
CEC5 (ALLIANCE A221208)	Phase II Study of Corticosteroid + Bevacizumab vs Corticosteroid + Placebo (BeST) for Radionecrosis after Radiosurgery for Brain Metastases Read More 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
CE4 (26021)	Observation Versus Conventional-Fractionated Radiotherapy or Radiosurgery After Non-Radical Surgery for Benign Intracranial Meningiomas: a Phase III Study. Read More 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
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. Read More 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
CE5S (NCIC CTG)	Socio-behavioral Study Work, Marriage/Social Support, Anxiety and Depression NCIC CTG CE5S Read More 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
CE3 (26981-22981)	A Randomized Phase III Study of Concomitant and Adjuvant Temozolomide and Radiotherapy For Newly Diagnosed Glioblastoma Multiforme Read More 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
CE2 (RTOG 94-02)	Phase III Intergroup Randomized Comparison of Radiation Alone versus Pre-radiation Chemotherapy For Pure and Mixed Anaplastic Oligodendrogliomas. Read More 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
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. Read More 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
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 Read More 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
CEC3 (NCCTG N107C)	A Phase III Trial of Post-Surgical Stereotactic Radiosurgery (SRS) Compared with Whole Brain Radiotherapy (WBRT) for Resected Metastatic Brain Disease Read More 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

Breast

ID	Study Title	Status
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 Read More 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. Read More 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
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. Read More 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. Read More 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. Read More 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 Read More 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: No Clinical Trials Application (Canada): No Coordination: Intergroup Led Trial Status: Open to Accrual Activation Date: August 28, 2024	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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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
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 Read More 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: Closed to Accrual Activation Date: October 07, 2003 Closing Date: April 30, 2010	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 Read More 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 Read More 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
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. Read More 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
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. Read More 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) Read More 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) Read More 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 Read More 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
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 Read More 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: Closed to Accrual Activation Date: October 07, 2003 Closing Date: March 11, 2011	Closed to Accrual
MA32D (ALLIANCE A211201)	Change In Mammographic Density with Metformin Use: A Companion Study to NCIC CTG Study MA.32 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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
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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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) Read More 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 Read More 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 Read More 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 Read More 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 Read More 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) Read More 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 Read More 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) Read More 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 Read More 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. Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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. Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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). Read More 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
MA29 (MA29)	A Feasibility Study of Pre-Operative Sunitinib (SU11248) With Multiple Pharmacodynamic Endpoints in Patients with T1c-T3 Operable Carcinoma of the Breast. Read More 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 Read More 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) Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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

ID	Study Title	Status
PAC5 (SWOG S2408)	A Randomized Phase III Multicentre Trial of Lanreotide for the Prevention of Postoperative Pancreatic Fistula Read More 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
HE2	SLIDE-HCC: Phase II trial of STRIDE (durvalumab + tremelimumab) + lenvatinib vs STRIDE in patients with unresectable hepatocellular carcinoma Read More 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
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. Read More 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
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) Read More 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
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. Read More 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 Read More 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
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. Read More 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
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. Read More 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 - Tehnically resectable disease Age >= 18 years and <=80 years - ECOG 0 - 1 - Adequate organ function - Women of chilbearing potential mist have a negative serum or urine pregnancy test Objectives: Primary - Overall survival (OS) with a minimum follow up of 2 years - Gloal 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 sitant relapse rates -Histopathological reponse - health economy - Surgical complications - Treatment-related adverse events and toxicity - Nutritional outcomes including weight development, dysphagia and appetite assessment - Gender strasified 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. Read More 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
PAC4 (ECOG-ACRIN EA2185)	Comparing the Clinical Impact of Pancreatic Cyst Surveillance Programs Read More 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
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) Read More 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
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 Read More 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
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 Read More 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
NEC3 (ALLIANCE A021202)	Prospective Randomized Phase II Trial of Pazopanib (NSC# 737754, IND 75648) Versus Placebo in Patients with Progressive Carcinoid Tumors Read More 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
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 Read More 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
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) Read More 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
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). Read More 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
GA1 (TROG 0808)	A Randomized Phase II/III Trial of Preoperative Chemoradiotherapy versus Preoperative Chemotherapy For Resectable Gastric Cancer (TOPGEAR) Read More 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
GA3 (AGITG-AG0315OG)	A Randomised Phase III Double-Blind Placebo-Controlled Study of Regorafenib in Refractory Advanced Gastro-Oesophageal Cancer (AGOC) Read More 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
CO27 (IROCAS)	A Phase III, Randomised, International Trial Comparing mFOLFIRINOX Triplet Chemotherapy to mFOLFOX for high Risk Stage III Colon Cancer in Adjuvant Setting Read More 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
CRC8 (ECOG-ACRIN EA2165)	A Randomized Phase III Study of Nivolumab after Combined Modality Therapy (CMT) in High-Risk Anal Cancer Read More 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
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) Read More 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
CO10	A Phase III Study of Immediate Versus Delayed Chemotherapy for Asymptomatic Advanced Colorectal Cancer Read More 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
CO9PA (98-46-54)	The Clinical and Pathologic Significance of Allelic Imbalance of 8p in Patients With Colorectal Cancer Read More 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 Read More 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 Read More 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 Read More 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 Read More 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. Read More 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. Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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. Read More 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) Read More 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 Read More 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
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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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) Read More 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
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 Read More 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
NEC2 (CALGB C80701)	Randomized Phase II Study of Everolimus Alone versus Everolimus Plus Bevacizumab in Patients with Locally Advanced or Metastatic Pancreatic Neuroendocrine Tumours Read More 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
CO3	Clinical Trial of Adjuvant Therapy With 5-Fluorouracil and Folinic Acid in Patients With Resectable Adenocarcinoma of the Colon Read More 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 Read More 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 Read More 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 Read More 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 Read More 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. Read More 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. Read More 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 Read More 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
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 Read More 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

Genito-urinary

ID	Study Title	Status
BLC6 (ALLIANCE A032103)	MODERN: An Integrated Phase 2/3 and Phase 3 Trial of MRD-Based Optimization of ADjuvant ThErapy in URothelial CaNcer Read More 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: Planned	Planned
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 Read More 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. Read More 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
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. Read More 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
PR20	A Randomized Phase III Trial of Local Ablative Therapy For Hormone Sensitive Oligometastatic Prostate Cancer [PLATON] The purpose of this study is to compare the effects of standard treatment to standard treatment plus ablative therapy (Radiotherapy or surgery) to all sites of disease in patients with oligometastatic hormone sensitive prostate cancer. It is not clear if ablative therapy (SBRT for example) to all sites of disease used in combination with standard treatments such as hormone therapy and/or chemotherapy can offer better results than standard treatment alone. This study will also obtain important information about the effects of treatment on quality of life, cost effectiveness, as well as predictive and prognostic correlative markers. Read More 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: Open to Accrual Activation Date: April 18, 2019	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. Read More 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
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] Read More 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 Read More 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) Read More 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 Read More 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
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 Read More 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
BLC4 (SWOG S1605)	Phase II Trial of Atezolizumab in BCG-Unresponsive Non-muscle Invasive Bladder Cancer Read More 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
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. Read More 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 Read More 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
PR21	A Randomized Phase II Study of 177Lu-PSMA-617 vs Docetaxel in Patients with Metastatic Castration-Resistant Prostate Cancer and PSMA-Positive Disease Read More 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 Read More 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 Read More 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 Read More 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. Read More 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 Read More 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 Read More 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 Read More 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. Read More 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 Read More 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 Read More 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 Read More 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 Read More 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) Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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) Read More 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 Read More 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 Read More 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. Read More 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 Read More 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 Read More 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) Read More 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

ID	Study Title	Status
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. Read More 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
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. Read More 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
EN11 (RAINBO GREEN)	RAINBO: Refining Adjuvant treatment IN endometrial cancer Based On molecular features, TransPORTEC platform trials - The MMRD-GREEN trial Read More 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
CX6 (GINECO CE106)	International Validation Study of Sentinel Node Biopsy in Early Cervical Cancer SENTICOL III Read More 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
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) Read More 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: Closed to Accrual Activation Date: August 02, 2012 Closing Date: November 29, 2019	Closed to Accrual
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. Read More 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: Closed to Accrual Activation Date: September 03, 2008 Closing Date: December 20, 2013	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 Read More 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
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 Read More 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
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) Read More 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 Read More 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
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 Read More 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
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) Read More 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
OV5A	Pilot Study of Weekly Adriamycin and Cisplatinum With Co-Trimoxazole Coverage in Patients With Stage III And IV Ovarian Cancer Read More 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. Read More 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) Read More 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. Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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
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 Read More 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 Read More 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. Read More 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 Read More 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 Read More 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 Read More 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 Read More 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
OV2	A Clinical Trial of Radiotherapy and Chemotherapy With Melphalan Following Surgery for Patients With Limited (Stage I, II & IIIo) Carcinoma of the Ovary Read More 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
OV11 (9619)	A Phase II Trial of Intraperitoneal Cisplatin and Intravenous and Intraperitoneal Paclitaxel in Women with Optimally-Debulked Stage III Epithelial Ovarian Cancer Read More 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
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 Read More 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
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 Read More 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
OV3	Second Co-operative Clinical Trial on Treatment of Ovarian Carcinoma Read More 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
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 Read More 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 Read More 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 Read More 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 Read More 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. Read More 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 Read More 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 Read More 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 Read More 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
GT1 (0174)	A Randomized Phase III Trial of Weekly Parenteral Methotrexate Versus "Pulsed" Dactinomycin for Primary Management of Low Risk Gestational Trophoblastic Neoplasia Read More 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

Head And Neck

ID	Study Title	Status
HN13	A Phase III Randomized Controlled Trial Comparing Palliative Stereotactic Body Radiotherapy vs. Palliative Standard Radiotherapy in Patients with Advanced Head and Neck Cancer Read More 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 the following sites: oro/hypopharynx, oral cavity, supraglottic larynx, unknown primary, maxillary sinus, nasal cavity. Stages T0-T4/N0-N3. No prior systemic therapy (including immunotherapy) or radiotherapy. Must be considered unfit for curative intent RT as determined by the treating oncologist(s). Geriatric 8 score <14. Ultrasound or MRI within the last 8-weeks. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-3. 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. Participation: Open to member centres NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: CCTG Led Trial Status: Planned	Planned
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. Read More 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 Read More 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) Read More 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 Read More 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 Read More 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 Read More 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. Read More 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 Read More 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 Read More 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 Read More 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

ID	Study Title	Status
ALC9 (MM2YA-EA01)	Eradicating Minimal Residual Disease in patients with AML prior to Stem Cell Transplant (ERASE): A MyeloMATCH Treatment Trial Read More 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 Read More 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: No Clinical Trials Application (Canada): No 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 Read More 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. Read More 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. Read More 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. Read More 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
LY17	A Multi-stage Randomized Phase II Study of Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma This is an unblinded (open-label) multi-centre randomized phase II trial of novel combination therapy in patients with relapsed and refractory aggressive B cell lymphoma, conducted by CCTG. The trial will open as a two arm comparison of Ibrutinib plus Rituximab, Gemcitabine, Dexamethasone, and Cisplatin (R-GDP) versus R-GDP alone, and will add a third arm of Rituximab plus dose-intensive cyclophosphamide, etoposide, and cisplatin (R-DICEP). The primary endpoint for the trial is overall response rate. Up to sixty-four patients will be accrued to each arm, with interim analyses scheduled when 16 and 32 patients have been enrolled. Individuals will be randomly assigned to initial therapy. Those with responsive disease will go on to receive autologous stem cell transplant (ASCT). The purpose of this randomized phase II "pick the winner" design is to facilitate efficient screening of novel combination treatment regimens and select those meeting pre-specified criteria for testing in the phase III setting. This study will also allow us to evaluate the predictive value of a number of biomarkers Read More 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: Open to Accrual Activation Date: May 05, 2015	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? Read More 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 Read More 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. Read More 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: No 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 Read More 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. Read More 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. Read More 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 Read More 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
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 Read More 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
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. Read More 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
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 Read More 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
ALC4 (ECOG E1910)	A Phase III Randomized Trial of Blinatumomab for Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia in Adults. Read More 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
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 Read More 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 Read More 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) Read More 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
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). Read More 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
HD4	A Clinical Trial of MOPP/ABV Hybrid versus Alternating MOPP/ABVD for Advanced or Recurrent Hodgkin's Disease Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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) Read More 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 Read More 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 Read More 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) Read More 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 Read More 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 Read More 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 Read More 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. Read More 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 Read More 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 Read More 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) Read More 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 Read More 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 Read More 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 Read More 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 Read More 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. Read More 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). Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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) Read More 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) Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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

ID	Study Title	Status
I204	A Phase II Study of PX-866 in Patients with Glioblastoma Multiforme at Time of First Relapse or Progression. Read More 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
I170	A Phase I/II Study of GW572016 in Patients With Recurrent Malignant Glioma Read More 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
I139	A Phase II Study of T138067-Sodium in Patients With Malignant Glioma Read More 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 Read More 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
I142	A Phase II Study of SarNU (NSC 364432) in Patients With Malignant Glioma Read More 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
I162	A Phase I Study Of Temozolomide And RAD001C In Patients With Malignant Glioma Read More 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
I48	NCIC CTG Phase II Study of "Intensive PCV-3" Chemotherapy For Anaplastic Oligodendroglioma Read More 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
I54	NCIC CTG Phase II Study of TCAR in Malignant Glioma Read More 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
I222	A Phase I Study of the mTORC1/mTORC2 Kinase Inhibitor AZD2014 in Patients with Previously Treated Glioblastoma Multiforme Read More 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
I109	NCIC CTG Phase II Study of Topotecan in Patients With Anaplastic Oligodendroglioma or Anaplastic Mixed Oligoastrocytoma Read More 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
I94	NCIC CTG Phase II Study of Gemcitabine in Patients With Malignant Glioma Read More 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 Read More 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 Read More 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
I76	NCIC CTG Phase II Study of Taxotere in Malignant Glioma Read More 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
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. Read More 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. Read More 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
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. Read More 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
I241B	A Phase II Study of RP-6306 in Patients with CDK4/6-Inhibitor Treated ER+HER2- Metastatic Breast Cancer Receiving Gemcitabine Read More 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
I239	A Phase II Study of CFI-400945 and Durvalumab in Patients with Advanced/Metastatic Triple Negative Breast Cancer (TNBC) Read More 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 Read More 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 Read More 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
I4B	NCIC CTG Phase II Study of Lonidamine in Breast Cancer Read More 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
I129	A Phase II Study of ZD0473 Given as a Short Infusion Every 3 Weeks to Patients With Advanced or Metastatic Breast Cancer Read More 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
I97	NCIC CTG Phase II Study of DPPE/Doxorubicin Chemotherapy in Metastatic Breast Cancer Read More 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
I93	NCIC CTG Randomized Phase II Study of High-Dose Paclitaxel With or Without Amifostine in Patients With Metastatic Breast Cancer Read More 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
I60	NCIC CTG Phase II Study of 10-EDAM in Patients With Metastatic Breast Cancer Read More 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
I73	NCIC CTG Phase II Study of the Progesterone Antagonist Mifepristone (RU486) in Metastatic Breast Cancer Read More 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
I213	A Randomized Phase II Study of Reolysin For Patients Receiving Standard Weekly Paclitaxel Therapy as Therapy For Advanced/Metastatic Breast Cancer Read More 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
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 Read More 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
I163	A Randomized Phase II Study of Two Different Schedules of RAD001C in Patients With Recurrent/Metastatic Breast Cancer Read More 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
I18	NCIC CTG Phase II Study of Flutamide in Breast Read More 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
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. Read More 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
I68	NCIC CTG Phase II Study of Taxotere in Patients With Metastatic Breast Cancer Read More 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
I35	NCIC CTG Phase II Study of CMF/Lonidamine in Breast Read More 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
I164	A Phase II Study of a Second Generation Clusterin Antisense Oligonucleotide (OGX-011) in Combination With Docetaxel in Advanced Breast Cancer Read More 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
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 Read More 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
I45	NCIC CTG Phase II Study of Oral Menogaril in Breast Cancer Read More 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
I19	NCIC CTG Phase II Study of Menogaril in Breast Read More 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
I229	A Phase 1b Pharmacodynamic Study of Durvalumab (MEDI4736) in Patients with HER-2 Positive Metastatic Breast Cancer (MBC) Receiving Trastuzumab Read More 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
I90	NCIC CTG Phase II Study of LY231514 in Patients With Locally Advanced/Metastatic Colorectal Cancer Read More 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 Read More 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 Read More 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. Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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. Read More 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 Read More 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) Read More 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 Read More 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 Read More 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) Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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). Read More 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 Read More 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. Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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
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. Read More 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. Read More 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. Read More 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 Read More 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 Read More 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 Read More 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 Read More 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
I126	A Phase II Study of Letrozole in Patients With Advanced or Recurrent Endometrial Cancer Read More 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
I148	A Phase II Study of OSI-774 (NSC 718781) in Patients With Locally Advanced and/or Metastatic Carcinoma of the Endometrium Read More 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
I160	A Phase II Study Of CCI-779 In Patients With Metastatic and/or Locally Advanced Recurrent Endometrial Cancer Read More 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 Read More 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 Read More 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. Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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
I12	NCIC CTG Phase II Study of CBDCA in Ovary Read More 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
I105	NCIC CTG Phase II Study of 776C85 Plus 5FU in Head and Neck Cancer Read More 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) Read More 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. Read More 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
I193	A Phase II Study of AT7519M, A CDK Inhibitor in Patients with Relapsed and/or Refractory Chronic Lymphocytic Leukemia. Read More 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 Read More 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 Read More 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 Read More 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 Read More 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. Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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
I191	A Phase II Study of AT9283 in Patients with Relapsed or Refractory Multiple Myeloma Read More 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
I78	NCIC CTG Phase II Study of Didemnin-B in Previously Untreated Patients With Favourable Histology Lymphoma Read More 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
I141	A Randomized Phase I Study of Two Different Schedules of BAY 43-9006 in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome Read More 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
I150	A Phase II Study of PS-341 (NSC 681239) in Patients With Untreated or Relapsed Mantle Cell Lymphoma Read More 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
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. Read More 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
I227	A Phase II/III Randomized Study of Pembrolizumab in Patients with Advanced Malignant Pleural Mesothelioma Read More 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: Closed to Accrual Activation Date: October 07, 2016 Closing Date: September 04, 2020	Closed to Accrual
I242A	A Phase II Pre-operative Trial of JDQ433 in Patients with Surgically Resectable Non-Small Cell Lung Cancer (NSCLC) Read More 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
I207	A Phase II Study of PF-03446962 in Patients with Advanced Malignant Pleural Mesothelioma Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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. Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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. Read More 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 Read More 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) Read More 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 Read More 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
I30	NCIC CTG Phase II Study of VP-16/Cisplatin in Mesothelioma Read More 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
I215	A Phase Ib Study of Selumetinib in Patients with Previously Treated or Untreated Advanced/Metastatic NSCLC Who are Receiving Standard Chemotherapy Regimens. Read More 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
I81	NCIC CTG Phase II Study of Tallimustine in Patients With Previously Treated Small Cell Lung Cancer Read More 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
I79	NCIC CTG Phase I/II Study of Taxol and Ifosfamide in Advanced Non-Small Cell Lung Cancer Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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 Read More 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

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