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Current Site Committee and Supportive Care TrialsCurrent = Active, Planned, Closed after January 01, 2002This information is intended for use by doctors and other health care professionals. If you are a cancer patient, we recommend that you discuss this information with your doctor, who knows you, and who has the facts about your disease. If you are interested in taking part in a clinical trial, your doctor can help explain how this information may apply to you, and if this is the best treatment option in your particular case. Last Updated: November 21, 2024 Disease SitesBRAINBREAST GASTRO-INTESTINAL GENITO-URINARY GYNECOLOGIC HEAD AND NECK HEMATOLOGIC LUNG MELANOMA OTHERS SARCOMA SYMPTOM CONTROL BRAINCE7CE9 CEC1 CEC2 CEC6 CEC7 BREASTMA32DMA33 MA34 MA36 MA37 MA39 MA40 MA41 MAC4 MAC5 MAC11 MAC12 MAC15 MAC18 MAC19 MAC20 MAC22 MAC23 MAC24 MAC25 MAC26 MAC27 MAC28 MAC29 MAC30 GASTRO-INTESTINALCO21CO27 CO29 CO32 CRC3 CRC6 CRC7 CRC8 CRC9 CRC10 ES3 GA1 GA3 GA4 HE1 HE2 NE1 NE2 NEC3 PA7 PAC3 PAC4 PAC5 GENITO-URINARYBL13BL13F BLC1 BLC4 BLC6 GCC1 PR17 PR19 PR20 PR21 PR22 PR24 PR25 PR26 PRC3 PRC4 REC4 GYNECOLOGICCX5CX6 CXC2 EN7 EN10 EN11 ENC1 OV25 OV26 OVC1 OVC2 VU2 HEAD AND NECKHN9HN10 HN11 HN13 HNC2 HEMATOLOGICAL5AL6 ALC4 ALC6 ALC7 ALC8 ALC9 CLC2 CLC2E CLC3 CLC3E HD11 HD12 HDC1 LY12 LY16 LY17 LY18 LYC1 MD1 MY13 MYC2 LUNGBR31BR34 BR36 BR38 BRC5 BRC6 BRC6B BRC6C BRC6D BRC6F BRC6G BRC6I BRC7 BRC8 MELANOMAME10ME13 ME13L ME15 ME17 MEC3 MEC5 MEC6 OTHERSPM1PM1S PM2 SARCOMASR7SRC6 SRC8 SYMPTOM CONTROLIC8ICC1 SC26 SC27 SC28 SC29 SC30 SC31 BRAIN STUDIESCE7A Phase III Trial of Stereotactic Radiosurgery Compared with Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) Plus Memantine for 5 or More Brain MetastasesEligibility: - 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: Intergroup(CCTG) Status: Open Activation Date: May 25, 2018 Chairs: (USA) Dr. Michael Chan, Wake Forest School of Medicine, 1(336) 713-3600 (Canada) Dr. David Roberge, CHUM-Centre Hospitalier de l'Universite de Montreal, 1(514) 890-8254 CE9Low and Anaplastic Grade Glioma Umbrella Study of Molecular Guided Therapies (LUMOS2)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(COGNO) Status: Open Activation Date: June 19, 2024 Chairs: (Canada) Dr. Marshall W. Pitz, CancerCare Manitoba, 1(204) 787-8642 CEC1Phase III Trial On Concurrent And Adjuvant Temozolomide Chemotherapy In Non-1p/19q Deleted Anaplastic Glioma. The CATNON Intergroup Trial.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(EORTC) Status: Closed Activation Date: July 22, 2009 , Closing Date: September 15, 2015 Chairs: (Canada) Dr. Warren Mason, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-2277 CEC6Phase 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 GliomaEligibility: 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(ALLIANCE) Status: Closed Activation Date: March 22, 2016 , Closing Date: June 10, 2024 Chairs: (Canada) Dr. J. Gregory Cairncross, Foothills Medical Centre, 1(403) 944-1260 CEC7Phase III Trial of Post-Surgical Single Fraction Stereotactic Radiosurgery (SRS) Compared with Fractionated SRS (FSRS) for Resected Metastatic Brain DiseaseEligibility: 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(ALLIANCE) Status: Closed Activation Date: May 22, 2020 , Closing Date: October 14, 2022 Chairs: (Canada) Dr. Jeffrey Greenspoon, Juravinski Cancer Centre at Hamilton Health Sciences, 1(905) 387-9495 BREAST STUDIESMA32DChange In Mammographic Density with Metformin Use: A Companion Study to NCIC CTG Study MA.32Eligibility: 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(ALLIANCE) Status: Closed Activation Date: March 18, 2015 , Closing Date: October 13, 2017 Chairs: (Canada) Dr. Pamela J. Goodwin, Mount Sinai Hospital, 1(416) 586-8605 (Canada) Dr. Pamela J. Goodwin, Mount Sinai Hospital, 1(416) 586-8605 (Canada) Dr. Swati Kulkarni, Windsor Regional Cancer Centre, 1(519) 253-5353 MA33A Randomised Phase III Study Of Radiation Doses And Fractionation Schedules For Ductal Carcinoma In Situ (DCIS) Of The BreastEligibility: 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(TROG) Status: Closed Activation Date: April 29, 2009 , Closing Date: June 20, 2014 Chairs: () Dr. Ivo A. Olivotto, , 1(778) 440-7322 MA37PALLAS: 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 CancerEligibility: 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(BIG) Status: Closed Activation Date: January 25, 2017 , Closing Date: November 30, 2018 Chairs: (Canada) Dr. Julie Lemieux, CHA-Hopital Du St-Sacrement, 1(418) 649-5726 MA39Tailor RT: A Randomized Trial of Regional Radiotherapy in Biomarker Low Risk Node Positive and T3N0 Breast CancerEligibility: 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: Intergroup(CCTG) Status: Open Activation Date: May 30, 2018 Chairs: (Canada) Dr. Timothy J. Whelan, Juravinski Cancer Centre at Hamilton Health Sciences, 1(905) 387-9495 MA40A 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)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 disorde rs. 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: NCIC CTG Status: Closed Activation Date: December 01, 2020 , Closing Date: May 07, 2024 Chairs: (Canada) Dr. Stephen Chia, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 2752 MA41De-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)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(BIG) Status: Closed Activation Date: January 27, 2023 , Closing Date: October 02, 2023 Chairs: (Canada) Dr. Philippe Bedard, University Health Network, 1(416) 946-4501 Ext. 4534 MAC15A 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.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(SWOG) Status: Closed Activation Date: October 05, 2011 , Closing Date: October 15, 2015 Chairs: (Canada) Dr. Sukhbinder Dhesy-Thind, Juravinski Cancer Centre at Hamilton Health Sciences, 1(905) 387-9495 Ext. 64431 (Canada) Dr. Stephen Chia, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 2752 MAC18POSITIVE: A Study Evaluating the Pregnancy Outcomes and Safety of Interrupting Endocrine Therapy for Young Women with Endocrine Responsive Breast Cancer who Desire PregnancyEligibility: 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(ALLIANCE) Status: Closed Activation Date: March 16, 2016 , Closing Date: January 02, 2020 Chairs: (Canada) Dr. Ellen Warner, Odette Cancer Centre, 1(416) 480-4617 MAC19A 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 ChemotherapyEligibility: 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(ALLIANCE) Status: Closed Activation Date: December 17, 2015 , Closing Date: July 01, 2022 Chairs: (Canada) Dr. Steven Latosinsky, London Regional Cancer Program, 1(519) 685-8500 Ext. 58740 MAC20Randomized Phase III Trial Evaluating the Role of Weight Loss In Adjuvant Treatment of Overweight and Obese Women with Early Breast CancerEligibility: 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(ALLIANCE) Status: Closed Activation Date: November 11, 2016 , Closing Date: February 15, 2021 Chairs: (Canada) Dr. Pamela J. Goodwin, Mount Sinai Hospital, 1(416) 586-8605 (Canada) Dr. Vanessa Bernstein, BCCA - Vancouver Island Centre, 1(250) 519-5571 MAC22Tomosynthesis Mammographic Imaging Screening Trial (TMIST)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 Participation: NCI US Affiliation? Yes Clinical Trials Application (Canada)? No Coordination: Intergroup(ECOG-ACRIN) Status: Open Activation Date: October 13, 2017 Chairs: (Canada) Dr. Martin Yaffe, Odette Cancer Centre, (416) 480-5715 MAC23RT CHARM:Phase III Randomized Trial of Hypofractionated Post-Mastectomy Radiation with Breast ReconstructionEligibility: 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(ALLIANCE) Status: Closed Activation Date: March 27, 2018 , Closing Date: August 11, 2021 Chairs: (Canada) Dr. Timothy J. Whelan, Juravinski Cancer Centre at Hamilton Health Sciences, 1(905) 387-9495 MAC24A 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 ChemotherapyEligibility: 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 ou tcomes. NCT Registration ID (from clinicaltrials.gov): NCT02954874 Participation: NCI US Affiliation? Yes Clinical Trials Application (Canada)? Yes Coordination: Intergroup(SWOG) Status: Closed Activation Date: December 11, 2018 , Closing Date: June 30, 2021 Chairs: (Canada) Dr. Christine Desbiens, CHA-Hopital Du St-Sacrement, 1(418) 682-7511 MAC25A Randomized, Double-Blind, Phase III Trial of Taxane/Trastuzumab/Pertuzumab with Atezolizumab or Placebo in First-Line HER2-Positive Metastatic Breast CancerEligibility: 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 pl acebo. NCT Registration ID (from clinicaltrials.gov): NCT03199885 Participation: Open to member centres NCI US Affiliation? Yes Clinical Trials Application (Canada)? Yes Coordination: Intergroup(NRG) Status: Closed Activation Date: January 08, 2020 , Closing Date: May 20, 2022 Chairs: (Canada) Dr. Stephen Chia, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 2752 MAC26A Phase II Randomized Trial of Olaparib (NSC-747856) Administered Concurrently with Radiotherapy versus Radiotherapy Alone for Inflammatory Breast CancerEligibility: 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(SWOG) Status: Closed Activation Date: May 28, 2019 , Closing Date: July 01, 2024 Chairs: (Canada) Dr. Eileen Rakovitch, Odette Cancer Centre, 1(416) 480-4974 MAC27COMPASSHER2 Residual Disease (RD), A Double-Blinded, Phase III Randomized Trial of T-DM1 and Placebo Compared with T-DM1 and TucatinibEligibility: 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(ALLIANCE) Status: Open Activation Date: March 03, 2022 Chairs: (Canada) Dr. Phillip Blanchette, London Regional Cancer Program, 1(519) 685-8640 MAC28A Phase III Clinical Trial Evaluating De-escalation of Breast Radiation for Conservative Treatment of Stage 1, Hormone Sensitive, HER2-Negative, Oncotype Recurrence ScoreEligibility: 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(NRG) Status: Open Activation Date: December 23, 2021 Chairs: (Canada) Dr. Valerie Theberge, CHUQ-Pavillon Hotel-Dieu de Quebec, 1(418) 691-5264 MAC29OptimICE-pCR: De-escalation of Therapy in Early-Stage TNBC Patients who Achieve pCR after Neoadjuvant Chemotherapy with Checkpoint Inhibitor TherapyEligibility: 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(ALLIANCE) Status: Open Activation Date: March 28, 2024 Chairs: (Canada) Dr. Stephen Chia, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 2752 MAC30A 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 ScoreEligibility: Female patients must be ? 18 years of age and premenopausal. May have ipsilateral or contralateral synchronous breast cancer if the highest stage tumor meets entry criteria. May have multicentric or multifocal breast cancer if the highest stage tumor meets entry criteria, and the other sites of disease would not require chemotherapy or HER2-directed therapy. Must have undergone axillary staging with sentinel node biopsy (SNB), targeted axillary dissection (TAD), or axillary lymph node dissection (ALND). Primary tumor must be pT1-3. (If N0, must be T1c or higher.). Ipsilateral nodes must be pN0 or pN1 (pN1mi, pN1a, pN1b, pN1c). Must be ER/PR postiive and HER2 negative. Objectives: To determine whether adjuvant chemotherapy (ACT) added to ovarian function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in improving invasive breast cancer-free survival (IBCFS) among premenopausal, early- stage breast cancer (EBC) patients with estrogen receptor (ER)-positive, HER2-negative tumors and 21-gene recurrence score (RS) between 16-25 (for pN0 patients) and 0-25 (for pN1 patients). NCT Registration ID (from clinicaltrials.gov): NCT05879926 Participation: Open to member centres NCI US Affiliation? Yes Clinical Trials Application (Canada)? No Coordination: Intergroup(NRG) Status: Open Activation Date: August 28, 2024 Chairs: (Canada) Dr. Jean-Pierre Ayoub, CHUM-Centre Hospitalier de l'Universite de Montreal, 1(514) 890-8000 Ext. 20692 GASTRO-INTESTINAL STUDIESCO21A 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).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: Intergroup(NCIC CTG) Status: Closed Activation Date: December 03, 2008 , Closing Date: January 24, 2024 Chairs: (Australia) Dr. Janette Vardy, Sydney Cancer Centre, 01161(29) 767-6345 (Australia) Dr. Janette Vardy, Sydney Cancer Centre, 01161(29) 767-6345 (Canada) Dr. Kerry Courneya, University of Alberta, 1(780) 492-1031 (Canada) Dr. Chris Booth, Cancer Centre of Southeastern Ontario at Kingston, 1(613) 549-6666 Ext. 4505 CO27A Phase III, Randomised, International Trial Comparing mFOLFIRINOX Triplet Chemotherapy to mFOLFOX for high Risk Stage III Colon Cancer in Adjuvant SettingEligibility: 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(UNICANC) Status: Closed Activation Date: May 02, 2017 , Closing Date: June 14, 2023 Chairs: (Canada) Dr. Sharlene Gill, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 2734 CO29Circulating Tumor DNA Analysis Informing Adjuvant Chemotherapy in Stage III Colon Cancer: A Multicentre Phase II/III Randomised Controlled Study (DYNAMIC III)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(AGITG) Status: Closed Activation Date: February 09, 2021 , Closing Date: March 31, 2023 Chairs: (Canada) Dr. Jonathan Loree, Canadian Cancer Trials Group, Queen's University, 1(613) 533-6430 Ext. 76816 CO32A Phase 3 Randomized Trial Of Neoadjuvant Chemotherapy, Excision And Observation versus Chemoradiotherapy For Early Rectal Cancer. The NEO-RT TrialEligibility: - 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: NCIC CTG Status: Open Activation Date: February 29, 2024 Chairs: (Canada) Dr. Carl Brown, St. Paul's Hospital, (604) 806-8711 (USA) Dr. Hagen Kennecke, Providence Portland Medical Centre, 1(503) 215-5696 CRC3A 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 MarkersEligibility: 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(ECOG) Status: Closed Activation Date: April 27, 2006 , Closing Date: February 11, 2011 Chairs: (Canada) Dr. Sheryl Koski, Cross Cancer Institute, 1(780) 432-8513 CRC6A Phase III Trial of 6 versus 12 Treatments of Adjuvant Folfox Plus Celecoxib or Placebo For Patients With Resected Stage III Colon CancerEligibility: 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(ALLIANCE) Status: Closed Activation Date: March 28, 2011 , Closing Date: November 20, 2015 Chairs: (Canada) Dr. Felix Couture, CHUQ - Hotel-Dieu de Quebec, 1(418) 691-5225 CRC7A 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)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(ALLIANCE) Status: Closed Activation Date: October 17, 2012 , Closing Date: December 28, 2018 Chairs: (Canada) Dr. Rebecca Ann Auer, Ottawa Hospital Research Institute, 1(613) 737-7700 Ext. 72791 CRC8A Randomized Phase III Study of Nivolumab after Combined Modality Therapy (CMT) in High-Risk Anal CancerEligibility: 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(ECOG-ACRIN) Status: Closed Activation Date: August 16, 2018 , Closing Date: August 24, 2021 Chairs: (Canada) Dr. Michael Vickers, Ottawa Hospital Research Institute, 1(613) 737-7700 Ext. 70185 CRC9Phase II/III Study of Circulating tumOr DNA as a Predictive BiomarRker in Adjuvant Chemotherapy in Patients with Stage IIA Colon Cancer (COBRA)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 D PD 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(NRG) Status: Closed Activation Date: April 21, 2020 , Closing Date: February 15, 2024 Chairs: (Canada) Dr. Howard Lim, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 672699 CRC10Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease (CIRCULATE-NORTH AMERICA)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 Participation: NCI US Affiliation? Yes Clinical Trials Application (Canada)? Yes Coordination: Intergroup(NRG) Status: Open Activation Date: May 04, 2023 Chairs: (Canada) Dr. Jonathan Loree, Canadian Cancer Trials Group, Queen's University, 1(613) 533-6430 Ext. 76816 ES3NEoadjuvant chemoradiotherapy for Esophageal squamous cell carcinoma versus Definitive chemoradiotherapy with salvage Surgery as needed (NEEDS Trial)Eligibility: - Histopathologically confirmed SCC of the esophagus in locally advanced stages ct1 N+ or ct2-4a any N, M0 - Technically resectable disease Age >= 18 years and <=80 years - ECOG 0 - 1 - Adequate organ function - Women of childbearing potential must have a negative serum or urine pregnancy test Objectives: Primary - Overall survival (OS) with a minimum follow up of 2 years - Global health-related quality of life (HRQOL) one year after randomization Secondary - HRQOL - Event free survival (EFS) defined as time to relapse, initiation of any anti-tumor therapy beyond study treatments or death - Loco-regional and distant relapse rates - Histopathological response - Health economy - Surgical complications - Treatment-related adverse events and toxicity - Nutritional outcomes including weight development, dysphagia and appetite assessment - Gender stratified analyses of all endpoints - Exploratory analysis for putative tissue and liquid biomarkers for response to RCT and benefit from either of the two treatment strategies Participation: Open to member centres NCI US Affiliation? No Clinical Trials Application (Canada)? Yes Coordination: Intergroup(KISU) Status: Open Activation Date: September 05, 2024 Chairs: (Canada) Dr. Jelena Lukovic, University Health Network, (416) 946-4501 GA1A Randomized Phase II/III Trial of Preoperative Chemoradiotherapy versus Preoperative Chemotherapy For Resectable Gastric Cancer (TOPGEAR)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(TROG) Status: Closed Activation Date: July 31, 2013 , Closing Date: July 01, 2021 Chairs: (Canada) Dr. Rebecca Wong, University Health Network, 1(416) 946-2126 GA3A Randomised Phase III Double-Blind Placebo-Controlled Study of Regorafenib in Refractory Advanced Gastro-Oesophageal Cancer (AGOC)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(AGITG) Status: Closed Activation Date: January 09, 2017 , Closing Date: February 03, 2021 Chairs: (USA) Dr. Thierry Alcindor, Dana-Farber Cancer Institute, 1 GA4A Randomized Phase II Study of Paclitaxel and Ramucirumab +/- Zanidatamab in HER2 Positive Advanced Gastroesophageal AdenocarcinomaEligibility: 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: NCIC CTG Status: Open Activation Date: November 22, 2023 Chairs: (Canada) Dr. Elena Elimova, University Health Network, (416) 946-4501 Ext. 2520 HE2SLIDE-HCC: Phase II trial of STRIDE (durvalumab + tremelimumab) + lenvatinib vs STRIDE in patients with unresectable hepatocellular carcinomaEligibility: Objectives: Participation: NCI US Affiliation? No Clinical Trials Application (Canada)? Yes Coordination: NCIC CTG Status: Planned Chairs: (Canada) Dr. Vincent Tam, Tom Baker Cancer Centre, 1(403) 521-3706 NE1NET RETREAT: A Phase II Study of 177Lutetium- DOTATATE Retreatment vs. Everolimus in Metastatic/unresectable Midgut NETEligibility: 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 Participation: NCI US Affiliation? Yes Clinical Trials Application (Canada)? Yes Coordination: NCIC CTG Status: Open Activation Date: June 05, 2023 Chairs: (USA) Dr. Aman Chauhan, Cancer Trials Support Unit, 1 (Canada) Dr. Simron Singh, Odette Cancer Centre, 1(416) 480-4928 NE2STOPNET - A Randomized Study of Cessation of Somatostatin Analogues after Peptide Receptor Radionuclide Therapy in Mid, Hind-Gut and Pancreatic Neuroendocrine TumoursEligibility: 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(AGITG) Status: Open Activation Date: July 22, 2024 Chairs: (Canada) Dr. Jonathan Loree, Canadian Cancer Trials Group, Queen's University, 1(613) 533-6430 Ext. 76816 (Canada) Dr. Rachel Goodwin, Ottawa Hospital Research Institute, 1(613) 737-8899 Ext. 70185 NEC3Prospective Randomized Phase II Trial of Pazopanib (NSC# 737754, IND 75648) Versus Placebo in Patients with Progressive Carcinoid TumorsEligibility: 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(ALLIANCE) Status: Closed Activation Date: February 28, 2014 , Closing Date: October 07, 2016 Chairs: (Canada) Dr. Tim Asmis, Ottawa Hospital Research Institute, 1(613) 737-7700 Ext. 79556 PA7A Randomized Phase II Trial of Gemcitabine and Nab-Paclitaxel vs Gemcitabine, Nab-Paclitaxel, Durvalumab and Tremelimumab as 1st Line Therapy in Metastatic Pancreatic AdenocarcinomaEligibility: 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: Intergroup(CCTG) Status: Closed Activation Date: August 22, 2016 , Closing Date: July 26, 2018 Chairs: (Canada) Dr. Daniel John Renouf, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 672357 PAC3Perioperative versus Adjuvant Chemotherapy for Resectable Pancreatic CancerEligibility: 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 Participation: NCI US Affiliation? Yes Clinical Trials Application (Canada)? No Coordination: Intergroup(ALLIANCE) Status: Open Activation Date: May 03, 2021 Chairs: (Canada) Dr. Daniel John Renouf, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 672357 PAC4Comparing the Clinical Impact of Pancreatic Cyst Surveillance ProgramsEligibility: 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(ECOG-ACRIN) Status: On Hold Activation Date: May 17, 2022 Chairs: (Canada) Dr. Paul Karanicolas, Odette Cancer Centre, 1(416) 480-4774 PAC5A Randomized Phase III Multicentre Trial of Lanreotide for the Prevention of Postoperative Pancreatic FistulaEligibility: Objectives: Participation: NCI US Affiliation? No Clinical Trials Application (Canada)? No Coordination: Intergroup(SWOG) Status: Planned Chairs: (Canada) Dr. Paul Karanicolas, Odette Cancer Centre, 1(416) 480-4774 GENITO-URINARY STUDIESBL13A Randomized Phase II Trial Assessing Trimodality Therapy With or Without Adjuvant Durvalumab (MEDI4736) to Treat Patients with Muscle-Invasive Bladder CancerEligibility: 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: NCIC CTG Status: Closed Activation Date: December 21, 2018 , Closing Date: January 31, 2023 Chairs: (Canada) Dr. Wassim Kassouf, The Research Institute of the McGill University, 1(514) 934-8246 BL13FElectronic '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]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: NCIC CTG Status: Closed Activation Date: July 15, 2020 , Closing Date: January 31, 2023 Chairs: (Canada) Dr. Doris Howell, University Health Network, 1(416) 946-4501 Ext. 3419 BLC1A 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 CancerEligibility: 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(SWOG) Status: Closed Activation Date: January 15, 2014 , Closing Date: February 15, 2017 Chairs: (Canada) Dr. Wassim Kassouf, The Research Institute of the McGill University, 1(514) 934-8246 BLC4Phase II Trial of Atezolizumab in BCG-Unresponsive Non-muscle Invasive Bladder CancerEligibility: 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(SWOG) Status: Closed Activation Date: April 07, 2017 , Closing Date: July 05, 2019 Chairs: (Canada) Dr. Peter Black, Clinical Research Unit at Vancouver Coastal, 1(604) 875-5003 (Canada) Dr. Wassim Kassouf, The Research Institute of the McGill University, 1(514) 934-8246 BLC6MODERN: An Integrated Phase 2/3 and Phase 3 Trial of MRD-Based Optimization of ADjuvant ThErapy in URothelial CaNcerEligibility: 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(ALLIANCE) Status: Planned Chairs: (Canada) Dr. Bernhard Eigl, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 2707 GCC1A Prospective Observational Cohort Study to Assess miRNA 371 for Outcome Prediction in Patients with Newly Diagnosed Germ Cell TumoursEligibility: 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 translation al 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(SWOG) Status: Closed Activation Date: August 27, 2020 , Closing Date: May 20, 2024 Chairs: (Canada) Dr. Lucia Nappi, BCCA - Vancouver Cancer Centre, (604) 877-6000 PR17Randomised Phase III Trial of Enzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer: ENZAMETEligibility: 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(ANZUP) Status: Closed Activation Date: February 02, 2015 , Closing Date: March 24, 2017 Chairs: (Canada) Dr. Scott North, Cross Cancer Institute, 1(780) 432-8762 PR19A Randomized Phase II Trial Evaluating High Dose Rate Brachytherapy and Low Dose Rate Brachytherapy as Monotherapy in Localized Prostate CancerEligibility: 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: Intergroup(CCTG) Status: Open Activation Date: November 04, 2016 Chairs: (Canada) Dr. Eric Vigneault, CHUQ - Hotel Dieu de Quebec, 1(418) 691-5264 (Canada) Dr. Gerard Morton, Odette Cancer Centre, 1(416) 480-6165 PR20A Randomized Phase III Trial of Local Ablative Therapy For Hormone Sensitive Oligometastatic Prostate Cancer [PLATON]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; parenchym al 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: NCIC CTG Status: Closed Activation Date: April 18, 2019 , Closing Date: October 17, 2024 Chairs: (Canada) Dr. M. Tamim Niazi, The Jewish General Hospital, 1(514) 340-8288 (Canada) Dr. Patrick C.F. Cheung, Odette Cancer Centre, 1(416) 480-6165 PR21A Randomized Phase II Study of 177Lu-PSMA-617 vs Docetaxel in Patients with Metastatic Castration-Resistant Prostate Cancer and PSMA-Positive DiseaseEligibility: 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: NCIC CTG Status: Closed Activation Date: December 17, 2020 , Closing Date: January 16, 2024 Chairs: (Canada) Dr. Fred Saad, CHUM-Centre Hospitalier de l'Universite de Montreal, 1(514) 890-8000 Ext. 27466 (Canada) Dr. Kim Chi, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 2746 (Canada) Dr. Francois Benard, BCCA - Vancouver Cancer Centre, (604) 675-8206 PR22DASL-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 CancerEligibility: 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(ANZUP) Status: Closed Activation Date: November 27, 2020 , Closing Date: July 14, 2023 Chairs: (Canada) Dr. M. Tamim Niazi, The Jewish General Hospital, 1(514) 340-8288 PR24Androgen 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)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: NCIC CTG Status: Open Activation Date: March 11, 2024 Chairs: (Canada) Dr. Douglas Andrew Loblaw, Odette Cancer Centre, 1(416) 480-4806 PR25A 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)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: NCIC CTG Status: Open Activation Date: October 08, 2024 Chairs: (Canada) Dr. Michael Kolinsky, Cross Cancer Institute, (780) 432-8762 PR26TRIPLE-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 ResponseEligibility: 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: NCIC CTG Status: Planned Chairs: (Canada) Dr. Michael Ong, Ottawa Hospital Research Institute, 1(613) 737-7700 Ext. 75051 PRC3A 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.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(ALLIANCE) Status: Closed Activation Date: October 15, 2007 , Closing Date: October 02, 2015 Chairs: (Canada) Dr. Martin E. Gleave, Clinical Research Unit at Vancouver Coastal, 1(604) 875-4111 PRC4Phase III Trial of Enzalutamide (NSC#766085) Versus Enzalutamide, Abiraterone and Prednisone for Castration Resistant Metastatic Prostate CancerEligibility: 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(ALLIANCE) Status: Closed Activation Date: October 27, 2014 , Closing Date: August 31, 2016 Chairs: (Canada) Dr. Kim Chi, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 2746 REC4A Phase 3 RandOmized Study Comparing PERioperative Nivolumab vs. Observation in Patients with Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC)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(ECOG-ACRIN) Status: Closed Activation Date: October 31, 2018 , Closing Date: June 09, 2021 Chairs: (Canada) Dr. Daniel Heng, Tom Baker Cancer Centre, 1(403) 521-3166 GYNECOLOGIC STUDIESCX6International Validation Study of Sentinel Node Biopsy in Early Cervical Cancer SENTICOL IIIEligibility: - 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(GINECO) Status: Closed Activation Date: July 24, 2020 , Closing Date: May 27, 2024 Chairs: (Canada) Dr. Vanessa Samouelian, CHUM-Centre Hospitalier de l'Universite de Montreal, 1(514) 890-8444 CXC2A 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 CancerEligibility: 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(NRG) Status: Closed Activation Date: April 30, 2021 , Closing Date: September 22, 2022 Chairs: (Canada) Dr. Eric Leung, Odette Cancer Centre, 1(416) 480-5000 Ext. 6165 EN7Randomized Phase III Trial Comparing Concurrent Chemoradiation and Adjuvant Chemotherapy with Pelvic Radiation Alone in High Risk and Advanced Stage Endometrial Carcinoma.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(DCGOG) Status: Closed Activation Date: September 03, 2008 , Closing Date: December 20, 2013 Chairs: (Canada) Dr. Paul Bessette, Centre hospitalier universitaire de Sherbrooke, 1(819) 346-1110 Ext. 13120 (Canada) Dr. Anthony Fyles, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-6522 (The Netherlands) Dr. Carien L. Creutzberg, The Dutch Gynecological Oncology Group (DGOG), 01131(71) 526-3052 EN10A Phase II Study of Tailored Adjuvant Therapy in POLE-mutated and p53-wildtype/NSMP Early Stage Endometrial Cancer (RAINBO BLUE & TAPER)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: NCIC CTG Status: Open Activation Date: December 19, 2022 Chairs: (Canada) Dr. Kathy Han, University Health Network, 1(416) 946-4501 Ext. 2919 (Canada) Dr. Jessica McAlpine, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 2395 EN11RAINBO: Refining Adjuvant treatment IN endometrial cancer Based On molecular features, TransPORTEC platform trials - The MMRD-GREEN trialEligibility: 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(DGOG) Status: On Hold Activation Date: July 07, 2023 Chairs: (Canada) Dr. Stephen Welch, London Regional Cancer Program, 1(519) 685-8640 ENC1A 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 CancerEligibility: 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(NRG) Status: Closed Activation Date: October 29, 2019 , Closing Date: December 06, 2022 Chairs: (Canada) Dr. Stephen Welch, London Regional Cancer Program, 1(519) 685-8640 OV25A 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)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: NCIC CTG Status: Closed Activation Date: April 06, 2018 , Closing Date: December 15, 2022 Chairs: (Canada) Dr. Amit M. Oza, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-2818 (Canada) Dr. Stephanie Lheureux, University Health Network, 1(416) 946-4501 Ext. 2415 OV26An 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 ChemotherapyEligibility: 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(UCLCTU) Status: Closed Activation Date: November 26, 2020 , Closing Date: May 24, 2023 Chairs: (Canada) Dr. Helen MacKay, Odette Cancer Centre, 1(416) 480-5145 OVC1A 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 CancerEligibility: 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(NRG) Status: Closed Activation Date: January 04, 2017 , Closing Date: November 10, 2017 Chairs: (Canada) Dr. Helen MacKay, Odette Cancer Centre, 1(416) 480-5145 OVC2A 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)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(NRG) Status: Closed Activation Date: January 19, 2017 , Closing Date: October 02, 2020 Chairs: (Canada) Dr. Diane Provencher, CHUM-Centre Hospitalier de l'Universite de Montreal, 1(514) 890-8444 VU2STRatIfication of Vulvar squamous cell carcinoma by HPV and p53 status to guide Excision: STRIVE StudyEligibility: 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: NCIC CTG Status: Open Activation Date: October 01, 2024 Chairs: (Canada) Dr. Jessica McAlpine, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 2395 (Canada) Dr. Amy Jamieson, University of British Columbia, (604) 729-1258 HEAD AND NECK STUDIESHN9Randomized 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)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: Intergroup(CCTG) Status: Closed Activation Date: January 31, 2018 , Closing Date: November 16, 2022 Chairs: (Canada) Dr. Anna Spreafico, University Health Network, 1(416) 946-4501 Ext. 4012 (Canada) Dr. Khalil Sultanem, The Jewish General Hospital, 1(514) 774-9875 HN10A Phase II Single Arm Trial of Elective Volume Adjusted De-Escalation Radiotherapy (EVADER) in Patients with Low-risk HPV-related Oropharyngeal Squamous Cell CarcinomaEligibility: 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: Intergroup(CCTG) Status: Closed Activation Date: February 20, 2019 , Closing Date: December 02, 2021 Chairs: (Canada) Dr. Kathy Han, University Health Network, 1(416) 946-4501 Ext. 2919 (Canada) Dr. Scott Bratman, University Health Network, (416) 946-4501 HN11SPECT-CT Guided ELEctive Contralateral Neck Treatment (Select) for Patients with Lateralized Oropharyngeal Cancer. A Phase III Randomized Controlled TrialEligibility: 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: NCIC CTG Status: Open Activation Date: September 29, 2022 Chairs: (Canada) Dr. John de Almeida, University Health Network, 1(416) 946-4501 (Canada) Dr. Ali Hosni Abdalaty, University Health Network, (416) 946-4501 Ext. 2126 HN13A Phase III Randomized Controlled Trial Comparing Palliative Stereotactic Body Radiotherapy vs. Palliative Standard Radiotherapy in Patients with Advanced Head and Neck CancerEligibility: Histologically confirmed mucosal squamous cell carcinoma (SCC) of the head and neck arising from at least one of the following sites: oro/hypopharynx, oral cavity, supraglottic larynx, maxillary sinus, nasal cavity, or unknown primary. Stages TX or T0-T4/N0-N3. Must be considered unfit for curative intent RT as determined by the treating oncologist(s). Geriatric 8 score <=14. 18+. Appropriate candidate for protocol radiotherapy. CT or MRI of the head and neck within 8 weeks prior to randomization. Chest CT or x-ray within 8 weeks prior to randomization. PET CT is permitted if CT is of diagnostic quality. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-3. Patients with a prior malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational treatment are eligible for this trial. Objectives: Primary Objective: To compare overall survival (OS) in participants with advanced head and neck cancer who receive palliative stereotactic body radiotherapy (SBRT) compared to palliative standard RT (SRT). Secondary Objectives: Progression Free Survival, Local Regional Failure Free Survival, Distant Metastases Free Survival, Response Rate (CR, PR, SD), Acute and long-term toxicity (CTC AE version 5.0), Treatment compliance, Patient-reported Outcomes (PROCTC-AE, FACT-HN), Resource utilization and health utilities. Tertiary Objectives: Compare OS in participants by ethnic or cultural origin, Determine if differences in OS (if any) are associated with social determinants of health, Identification and assessment of prognostic biomarkers from diagnostic or planning scans, archival tumour, and baseline blood samples. NCT Registration ID (from clinicaltrials.gov): NCT06641791 Participation: Open to member centres NCI US Affiliation? No Clinical Trials Application (Canada)? No Coordination: NCIC CTG Status: Open Activation Date: October 31, 2024 Chairs: (Canada) Dr. Ian D.T. Poon, Odette Cancer Centre, 1(416) 480-4974 HNC2Randomized 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 CisplatinEligibility: 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(NRG) Status: Closed Activation Date: May 10, 2019 , Closing Date: September 01, 2022 Chairs: (Canada) Dr. Eric W. Winquist, London Regional Cancer Program, 1(519) 685-8261 HEMATOLOGIC STUDIESAL5Dana Farber Cancer Institue (DFCI) Acute Lymphoblastic Leukemia (ALL) Adult Consortium Trial: Adult ALL TrialEligibility: 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(DFCI) Status: Closed Activation Date: September 10, 2008 , Closing Date: January 08, 2013 Chairs: (Canada) Dr. Julie Bergeron, Hopital Maisonneuve-Rosemont, 1(514) 252-3400 Ext. 3404 AL6A 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 TrialEligibility: 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: NCIC CTG Status: Open Activation Date: July 18, 2024 Chairs: (Canada) Dr. Sarit Assouline, The Jewish General Hospital, 1(514) 340-8207 (Canada) Dr. Mary Lynn Savoie, Tom Baker Cancer Centre, 1(403) 944-1564 ALC4A Phase III Randomized Trial of Blinatumomab for Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia in Adults.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(ECOG) Status: Closed Activation Date: March 24, 2017 , Closing Date: October 15, 2019 Chairs: (Canada) Dr. Julie Bergeron, Hopital Maisonneuve-Rosemont, 1(514) 252-3400 Ext. 3404 ALC6A 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 ALLEligibility: 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(ALLIANCE) Status: On Hold Activation Date: April 12, 2019 Chairs: (Canada) Dr. Jill Fulcher, Ottawa Hospital Research Institute, (613) 737-8899 Ext. 71284 ALC7MYELOMATCH, Master Screening and Reassessment Protocol (MSRP) for Tier Advancement in the NCI MYELOMATCH Clinical TrialsEligibility: 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(SWOG) Status: Open Activation Date: May 29, 2024 Chairs: (Canada) Dr. Aly Karsan, BCCA - Vancouver Cancer Centre, 1(604) 877-6248 ALC8A 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 TrialEligibility: -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(SWOG) Status: Open Activation Date: September 25, 2024 Chairs: (Canada) Dr. Guillaume Richard-Carpentier, Princess Margaret Cancer Centre, 1(416) 946-4501 Ext. 5375 ALC9Eradicating Minimal Residual Disease in patients with AML prior to Stem Cell Transplant (ERASE): A MyeloMATCH Treatment TrialEligibility: - 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(ECOG-ACRIN) Status: Planned Chairs: (Canada) Dr. Lee Mozessohn, Odette Cancer Centre, (416) 480-5000 Ext. 5847 CLC2A 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).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(ALLIANCE) Status: Closed Activation Date: February 05, 2015 , Closing Date: May 01, 2016 Chairs: (Canada) Dr. Carolyn Owen, Tom Baker Cancer Centre, 1(403) 521-3621 CLC2EA 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 LeukemiaEligibility: 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 Status: Closed Activation Date: March 13, 2015 , Closing Date: May 01, 2016 Chairs: (Canada) Dr. Matthew Cheung, Odette Cancer Centre, 1(416) 480-5000 Ext. 4757 CLC3Randomized 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 StudyEligibility: 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(SWOG) Status: Open Activation Date: December 23, 2021 Chairs: (Canada) Dr. Versha Banerji, CancerCare Manitoba, 1(204) 787-4904 CLC3EAn 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 TrialEligibility: Participants who are eligible for the core CLC.3 study are eligible and included in the CLC.3E sub-study Objectives: Primary: To determine the incremental cost-utility ratio of an early novel therapy approach (venetoclax-obinutuzumab) compared to a deferred approach in Canadian patients with high-risk CLL. Direct medical costs will be estimated from the perspective of the Canadian public healthcare system. The denominator of the ratio will be expressed in quality-adjusted life years gained. Secondary: To determine the incremental cost-effectiveness ratio of an early novel therapy approach compared to a deferred approach in Canadian patients with high-risk CLL (enrolled in the randomized component of the SWOG S1925/CLC3 study). Effectiveness will be expressed in life years gained and years to second progression gained. To determine direct medical costs of care, to compare change in health preference (utility) over time, and to compare the lost productivity for Canadian individuals with high-risk CLL. NCT Registration ID (from clinicaltrials.gov): NCT05371808 Participation: Limited to invited centres NCI US Affiliation? Yes Clinical Trials Application (Canada)? No Coordination: NCIC CTG Status: Open Activation Date: May 10, 2022 Chairs: (Canada) Dr. Matthew Cheung, Odette Cancer Centre, 1(416) 480-5000 Ext. 4757 HD11A 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 LymphomaEligibility: 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: NCIC CTG Status: Open Activation Date: March 03, 2022 Chairs: (Canada) Dr. Kerry J. Savage, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 2641 (Canada) Dr. John Kuruvilla, University Health Network, 1(416) 946-2827 HD12A 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)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(UCLCTU) Status: Open Activation Date: August 08, 2023 Chairs: (Canada) Dr. Michael Crump, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-4501 Ext. 4567 HDC1A 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 LymphomaEligibility: 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(SWOG) Status: Closed Activation Date: December 08, 2020 , Closing Date: December 01, 2022 Chairs: (Canada) Dr. Angela Punnett, The Hospital for Sick Children, 1(416) 813-5872 (Canada) Dr. Kelly Davison, The Research Institute of the McGill University, 1(514) 934-1934 Ext. 31558 (Canada) Dr. Michael Crump, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-4501 Ext. 4567 LY12A 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.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: Intergroup(CCTG) Status: Closed Activation Date: August 07, 2003 , Closing Date: December 31, 2012 Chairs: (Canada) Dr. Michael Crump, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-4501 Ext. 4567 (Italy) Prof. Massimo Federico, Gruppo Italiano Studio Linfomi (GISL), 01139(59) 422-4383 LY16A 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 LymphomaEligibility: 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(LYSARC) Status: Closed Activation Date: June 17, 2013 , Closing Date: November 10, 2014 Chairs: (Canada) Dr. Laurie Sehn, BCCA - Vancouver Clinic, 1(604) 877-6000 Ext. 2736 LY17A Multi-stage Randomized Phase II Study of Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell LymphomaEligibility: 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: Intergroup(CCTG) Status: Open Activation Date: May 05, 2015 Chairs: (Canada) Dr. John Kuruvilla, University Health Network, 1(416) 946-2827 (Canada) Dr. Michael Crump, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-4501 Ext. 4567 LY18A Phase I Master Protocol of Novel Combination Therapy for Patients with Relapsed or Refractory Aggressive B-Cell LymphomaEligibility: 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: Intergroup(CCTG) Status: Open Activation Date: December 06, 2019 Chairs: (Canada) Dr. Sarit Assouline, The Jewish General Hospital, 1(514) 340-8207 LYC1Intergroup 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)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(ECOG) Status: Closed Activation Date: March 12, 2014 , Closing Date: September 09, 2016 Chairs: (Canada) Dr. Michael Crump, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-4501 Ext. 4567 MD1CALMS: Combination Therapy with Luspatercept in Lower Risk MDS: A Non-Comparative, Parallel, Multi-Arm Phase 2 Study: A myeloMATCH Treatment TrialEligibility: Objectives: Participation: NCI US Affiliation? Yes Clinical Trials Application (Canada)? Yes Coordination: NCIC CTG Status: Planned Chairs: (Canada) Dr. Rena Buckstein, Odette Cancer Centre, 1(416) 480-5000 Ext. 5847 MY13A Phase III Non-Inferiority Randomized Controlled Trial of Fixed Duration versus Continuous Daratumumab Among Transplant Ineligible Older Adults with Newly Diagnosed Multiple MyelomaEligibility: 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 Participation: NCI US Affiliation? No Clinical Trials Application (Canada)? No Coordination: NCIC CTG Status: Open Activation Date: December 08, 2023 Chairs: (Canada) Dr. Hira Mian, Juravinski Cancer Centre at Hamilton Health Sciences, (905) 387-9495 MYC2A 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)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 re mission. 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(SWOG) Status: Open Activation Date: April 11, 2022 Chairs: (Canada) Dr. Christopher Venner, BCCA - Vancouver Cancer Centre, 1 LUNG STUDIESBR31A Phase III Prospective Double Blind Placebo Controlled Randomized Study of Adjuvant MEDI4736 in Completely Resected Non-Small Cell Lung CancerEligibility: Completely resected primary stage IB (>= 4cm), II and IIIA non-small cell lung cancer patients (with or without adjuvant platinum based chemotherapy). Objectives: Primary Objective: Disease free survival (DFS) for patients with NSCLC that is PD-L1 positive. Disease free survival (DFS) in all randomized patients. Secondary Objectives: Overall survival (OS) for patients with NSCLC that is PD-L1 positive, OS for all randomized patients, lung cancer specific survival for patients with NSCLC that is PD-L1 positive and all randomized patients, adverse effects and tolerability of MEDI4736, Quality of Life, survival benefits participants judge necessary to make adjuvant immunotherapy worthwhile, economic evaluation (cost effectiveness and cost utility), evaluation of predictive/prognostic significance of PD-L1 expression, evaluation of changes in plasma/serum cytokines and other blood and tissue based biomarkers after treatment with MEDI4736 and at disease event, exploratory pharmacogenomic assays (baseline only). NCT Registration ID (from clinicaltrials.gov): NCT02273375 Participation: Open to member centres NCI US Affiliation? No Clinical Trials Application (Canada)? Yes Coordination: Intergroup(CCTG) Status: Closed Activation Date: October 09, 2014 , Closing Date: March 27, 2020 Chairs: () Dr. Yi-Long Wu, Chinese Thoracic Oncology Group, (Italy) Dr. Francesco Perrone, Istituto Nazionale Tumori, 01139(81) 590-3571 (Canada) Dr. Glenwood Goss, Ottawa Hospital Research Institute, 1(613) 737-8899 Ext. 73955 BR34A Randomized Trial of Durvalumab and Tremelimumab +/- Platinum Based Chemotherapy in Patients with Metastatic (Stage IV) Squamous or Non-Squamous Non-Small Cell Lung Cancer (NSCLC)Eligibility: - histologically and/or cytologically confirmed squamous or non-squamous NSCLC confirmed by IHC. Known EGFR mutations or ALK fusions are NOT eligible. - stage IVA or IVB per TNM version 8 staging criteria - must consent to tissue submission for PD-L1 testing. - measureable disease (RECIST 1.1) assessed within 28 days prior to randomization - 18 years of age or older - ECOG 0 or 1 - adequate hematology and biochemistry - no prior cytotoxic chemotherapy for advanced/metastatic disease - no prior EGFR, ALK inhibitors or immunotherapy Objectives: Primary Objective To compare the overall survival (OS) of patients receiving durvalumab, tremelimumab plus platinum-based chemotherapy to that of patients receiving durvalumab and tremelimumab alone. Secondary Objectives - To compare progression free survival (PFS; RECIST 1.1) at 1 year between arms - To compare objective response rate (ORR; RECIST 1.1 and iRECIST) between arms - To compare Quality of life (QoL) between arms - To evaluate the nature, severity, and frequency of toxicities between arms. - To evaluate the incremental cost effectiveness and cost utility ratios between arms - To correlate the expression of tissue (including PD-L1) and blood markers with outcomes and response. Exploratory Objectives - To evaluate the correlation between aberrations detected using genomic cell-free DNA in blood and outcomes - Progression free survival as defined by iRECIST NCT Registration ID (from clinicaltrials.gov): NCT03057106 Participation: Open to member centres NCI US Affiliation? No Clinical Trials Application (Canada)? Yes Coordination: Intergroup(CCTG) Status: Closed Activation Date: February 15, 2017 , Closing Date: November 07, 2018 Chairs: (Canada) Dr. Natasha Leighl, University Health Network, 1(416) 946-4645 BR36A Biomarker-Directed, Multi-Centre Phase II/III Study of CTDNA Response Adaptive Immuno-Chemotherapy in Non-Small Cell Lung CancerEligibility: Eligibility: MAIN INCLUSION CRITERIA: Patients with metastatic NSCLC that is EGFR and ALK mutation negative, PD-L1 expression Tumour Proportion Score (TPS) ? 50% who are willing and able to receive continued pembrolizumab or addition of standard platinum-based combination therapy added to pembrolizumab after initial 6 weeks (after 2 Q3W doses or 1 Q6W dose) of pembrolizumab as systemic immunotherapy. ECOG 0-2. Clinically/radiologically evaluable disease, RECIST 1.1 measurable disease not required. Mandatory blood collection of ctDNA for screening. MAIN EXCLUSION CRITERIA: Symptomatic/unstable CNS metastases. Patients who are not suitable candidates for treatment with pembrolizumab as a single agent or in combination with standard platinum combination chemotherapy. Objectives: Primary: Phase II progression free survival (PFS), Phase III overall survival (OS). Secondary: Phase II feasibility, RECIST response rate post randomization, safety/tolerability; Phase III RECIST response rate post randomization, response duration, progression free survival, and safety/tolerability. NCT Registration ID (from clinicaltrials.gov): NCT04093167 Participation: Open to member centres NCI US Affiliation? No Clinical Trials Application (Canada)? No Coordination: NCIC CTG Status: Open Activation Date: October 17, 2019 Chairs: (USA) Valsamo Anagnostou, The Sidney Kimmel Comprehensive Cancer Centre, (410) 502-3696 (Canada) Dr. Cheryl Ho, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 2445 BR38Consolidative Use of Radiotherapy to Block (CURB2) Oligoprogression In Patients with Metastatic Non-Small-Cell Lung Cancer-A Randomized Phase 3 TrialEligibility: Participants with metatstatic, histologically confirmed non-small cell lung cancer, without an actionable driver mutataion, for whom either immune checkpoint inhibition (ICI) alone or in combination with chemotherapy is indicated. Participants must have oligoprogression on first-line ICI +/- chemotherapy after at least 3 cycles. All sites of oligopregression must be amenable to treatment with stereotactic body radiation therapy (SBRT) or ablative radiotherapy. Objectives: 1) To evaluate if the addition of SBRT to extra-cranial oligoprogressive metastatic disease can prolong progression-free survival (PFS) and/or overall survival (OS) compared to SOC systemic therapy alone in participants with oligoprogressive NSCLC. 2) To evaluate both treatment strategies with respect to: Safety and tolerability (using CTCAE Version 5.0); Participant-reported adverse events (using PRO-CTCAE questionnaire); Participant-reported quality of life (using EORTC-QLQ-C30 and QLQ-LC13 questionnaires); Cost-effectiveness (using EQ-5D-5L questionnaire; CCTG Canadian sites only) 3) To determine biomarkers of response and resistance using peripheral blood and tissue samples. NCT Registration ID (from clinicaltrials.gov): NCT06686771 Participation: Open to member centres NCI US Affiliation? Yes Clinical Trials Application (Canada)? No Coordination: NCIC CTG Status: Planned Chairs: (Canada) Dr. Chiaojung Jillian Tsai, University Health Network, (416) 946-4501 BRC5A Phase III Randomized Trial of Lobectomy Versus Sublobular Resection For Small, (Eligibility: Non Small Cell Lung Cancer - Stage 1 Objectives: Primary Objective: To determine whether DFS after sublobar resection (segmentectomy or wedge) is non-inferior to that after lobectomy in patients with small peripheral NSCLC. Secondary Objectives: To determine whether overall survival(after sublobar resection) is non-inferior to that after lobectomy; to determine the rates of loco-regional and systemic recurrence (exclusive of second primaries) after lobar and sublobar resection; to determine the difference between the two arms of the study in pulmonary function as determined by expiratory flow rates measured at 6 months post-operatively. Imaging Substudy: To explore the relationship between characteristics of the primary lung cancer, as revealed by pre-operative CT and PET imaging, and outcomes; a determination of the false-negative rate of the pre-operative PET scan for identification of involved hilar and mediastinal lymph nodes; and an assessment of the utility of annual follow-up CT imaging after surgical resec tion. NCT Registration ID (from clinicaltrials.gov): NCT00499330 Participation: Open to member centres NCI US Affiliation? Yes Clinical Trials Application (Canada)? No Coordination: Intergroup(ALLIANCE) Status: Closed Activation Date: February 07, 2008 , Closing Date: April 04, 2017 Chairs: (Canada) Dr. Massimo Conti, University Institute of Cardiology and, 1(418) 656-8711 BRC6A Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung CancerEligibility: PRE-SCREENING/SCREENING ELIGIBIILITY - patients must: (1) have pathologically proven Stage IV squamous cell lung cancer, (2) have an adequate tissue specimen as defined in the protocol and confirmed by the local pathologist, (3) not have a known EGFR mutation or ALK fusion, (4) must either be eligible to be screened at progression on prior treatment or to be pre-screened prior to progression on current treatment, (5) have Zubrod PS 0-1, (4) be > or = 18 years of age, (5) be offered participation in banking for future use of specimens (6) have previously received or currently be receiving a platinum-based chemotherapy regimen. Objectives: (1) to establish a NCTN mechanism for genomically screening large but homogeneous cancer populations & subsequently assigning and accruing simultaneously to a multi-sub-study Master Protocol. Each of the biomarker-driven sub-studies in this protocol will evaluate a targeted therapy (TT) or targeted therapy combination (TTC) based on a designated therapeutic biomarker-drug combination, with the ultimate goal being approval of new targeted therapies in this setting. Non-match sub-studies will evaluate nonmatch therapies (NMT) in patients not eligible for any of the biomarker-driven sub-studies, also with the goal of approval (2) to evaluate the screen success rate defined as the percentage of screened patients that register for a therapeutic sub-study, (3) to establish a tissue/ blood repository from patients with refractory squamous cell cancer. NCT Registration ID (from clinicaltrials.gov): NCT02154490 Participation: Open to member centres NCI US Affiliation? Yes Clinical Trials Application (Canada)? Yes Coordination: Intergroup(SWOG) Status: Closed Activation Date: April 15, 2016 , Closing Date: July 12, 2018 Chairs: (Canada) Dr. Natasha Leighl, University Health Network, 1(416) 946-4645 BRC6BA Phase II Study of GDC-0032 (Taselisib) for Previously Treated PI3K Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-Map Sub-Study)Eligibility: Patients must:(1) be assigned to BRC6B (i.e., defined as PI3K positive after biomarker testing),(2) have a HbAic <7% and fasting glucose < 125 mg/dL,(3) not have Type I or II diabetes that requires anti-hyperglycemic medication,(4) not have active or history of small or large intestine inflammation (eg. Crohn's disease or ulcertive colitis),(5) not require daily supplemental O2,(6) be able to take oral medications. Patients may not have any impairment or gastrointestinal function or disease that may significantly alter absorption of Taselisib-eg. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection,(7) not be taking, or plan to take while on protocol treatment and for 14 days post last dose of study treatment, drugs, herbal supplements, or foods that are known to be strong/moderate CYP3A4 substrates,(8) be offered participation in banking for future use of specimens,(9) see also common eligibility criteria of main BRC6 trial. Objectives: (1) to evaluate Taselisib (GDC-0032), a PI3K inhibitor, in PI3K-positive patients,(2) within Ph II component of BRC6B, to evaluate if there is sufficient evidence to continue to Ph III,(3) to evaluate investigator-assessed PFS & OS (4)to evaluate ORR,(5) to establish a tissue/blood repository from patients with refractory lung squamous cell carcinoma, (6) to evaluate DOR,(7) to evaluate frequency & severity of toxicities associated with Taselisib,(8) to identify additional predictive tumour/blood biomarkers that may modify response or define resistance to Taselisib,(9) to identify potential resistence biomarkers at PD. NCT Registration ID (from clinicaltrials.gov): NCT02154490 Participation: NCI US Affiliation? Yes Clinical Trials Application (Canada)? No Coordination: Intergroup(SWOG) Status: Closed Activation Date: April 15, 2016 , Closing Date: December 13, 2016 Chairs: (Canada) Dr. Natasha Leighl, University Health Network, 1(416) 946-4645 BRC6CA Phase II Study of Palbociclib for Previously Treated Cell Cycle Gene Alteration Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-Map Sub-Study)Eligibility: Patients must: (1) be assigned to BRC6C (i.e., defined as Cell Cycle Gene Alteration Positive, (2) not be taking within 7 days prior to sub-study registration, nor plan to take while on protocol treatment and for 14 days after the last dose of study treatment, strong CYP3A4 inhibitors and/or strong CYP3A4 inducers, and/or drugs known to prolong the QT interval, (3) not have a screening QTcF interval > 480 msec based on the average of triplicate EKGs performed within 28 days prior to registration, (4) be able to take oral medications, (5) be offered participation in banking for future use of specimens,(6) see also common eligibility criteria of main BRC6 trial. Objectives: (1) within Ph II component of BRC6C, to evaluate if there is sufficient evidence to continue to Ph III by evaluating ORR for cell cycle gene alteration positive patients registered to BRC6C treated with palbociclib,(2) to evaluate investigator-assessed PFS & OS cell cycle gene alteration-positive treatments with palbociclib, (3) to evaluate duration of response (DoR) among cell cycle gene alteration positive patients treated with palbociclib who achieve a CR or PR by RECIST 1.1, (4) to evaluate frequency & severity of toxicities associated with palbociclib, (5) to identify additional predictive tumour/blood biomarkers that may modify response or define resistance to palbociclib, (6) identify potential resistance biomarkers at PD, (7) establish a tissue/ blood repository from patients with refractory squamous cell carcinoma of the lung. NCT Registration ID (from clinicaltrials.gov): NCT02154490 Participation: NCI US Affiliation? Yes Clinical Trials Application (Canada)? No Coordination: Intergroup(SWOG) Status: Closed Activation Date: April 15, 2016 , Closing Date: September 01, 2016 Chairs: (Canada) Dr. Natasha Leighl, University Health Network, 1(416) 946-4645 BRC6DA Phase II Study of AZD4547 for Previously Treated FGFR-Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-Map Sub-Study)Eligibility: Patients must:(1)be assigned to BRC6D (i.e., defined as FGFR positive),(2)be 25 years,(3)not be taking drugs, herbal supplements or foods that are known to be strong/moderate CYP3A4-CYP2D6 substrates,(4)not have received nitrosourea or mitomycin C within 42 D prior to sub-study registration, (5) not have had any prior exposure to any agent with FGFR inhibition as its primary pharmacology,(6)not have a mean resting QTc > 450 msec obtained from 3 consecutive ECGs,(7)not be planning to receive any concomitant medication known to prolong QT interval, (8) be able to take oral medications,(9)not have a history of hypersensitivity to active or inactive excipients of AZD4547 or with a similar chemical structure or class,(10) not have any of the listed ophthalmological criteria, (11) have an eye exam,(12)have corrected Ca and Phos < ULN,(13)have MUGA/echocardiogram,(14)be offered participation in banking for future use of specimens,(15)see also common eligibility criteria of main BRC6 trial. Objectives: (1) within Ph II component of BRC6D, to evaluate if there is sufficient evidence to continue to Ph III by evaluating ORR with AZD4547 in FGFR-positive patients,(2) to evaluate investigator-assessed PFS & OS in FGFR-positive patients treated with AZD4547, (3) to evaluate duration of response (DoR) among FGFR positive patients treated with AZD4547 who achieve a CR or PR by RECIST 1.1, (4) to evaluate frequency & severity of toxicities associated with AZD4547 in FGFR positive patients, (5) to identify additional predictive tumour/blood biomarkers that may modify response or define resistance toAZD4547 beyond the chosen biomarker for biomarker-driven sub-studies, (6) identify potential resistance biomarkers at PD, (7) establish a tissue/ blood repository from patients with refractory squamous cell carcinoma of the lung. NCT Registration ID (from clinicaltrials.gov): NCT02154490 Participation: NCI US Affiliation? Yes Clinical Trials Application (Canada)? No Coordination: Intergroup(SWOG) Status: Closed Activation Date: April 15, 2016 , Closing Date: October 31, 2016 Chairs: (Canada) Dr. Natasha Leighl, University Health Network, 1(416) 946-4645 BRC6GA Phase II Study of Talazoparib (BMN 673) in Patients with Homologous Recombination Repair Deficiency Positive Stage IV Squamous Cell Lung Cancer (Lung-Map Sub-Study)Eligibility: Patients must: (1) be assigned to BRC6G (i.e., defined as HRRD positive),(2) not have prior exposure to any agent with a PARP inhibitor,(3) have achieved SD, a PR, or a CR at their first assessment after initiating first-line platinum-based chemotherapy, (4) not have any impairment of GI function or GI disease that may significantly alter absorption of talazoparib, (5) be able to take oral medications, (6) not be taking, nor plan to take while on protocol treatment strong P-gp inhibitors, P-gp inducers, or BCRP inhibitors, (7) agree to have blood specimens submitted for PK analysis, (8) see also common eligibility criteria of main BRC6 trial. Objectives: (1) to evaluate the overall response rate (ORR) (confirmed and unconfirmed, complete and partial) with talazoparib in HRRD MDVN-positive patients, (2) to evaluate investigator- assessed PFS (IA-PFS) & OS associated with therapy in HRRD MDVN-positive patients, (3) to evaluate ORR, IA-PFS, and OS in HRRD FMI-positive patients, (4) to evaluate ORR in HRRD MDVN-negative/ HRRD FMI-positive patients, (5) to evaluate the frequency and severity of toxicities associated with talazoparib in HRRD FMI-positive patients, (6) to assess if the HRD score is associated with clinical outcomes (response, PFS, OS) in HRRD FMI-positive patients treated with talazoparib, (7) to assess if the level of PARP protein expression determined by immunohistochemistry is associated with clinical outcomes (response, PFS, OS) in HRRD FMI-positive patients treated with talazoparib, (8) to characterize pharmacokinetic properties of talazoparib. Participation: NCI US Affiliation? Yes Clinical Trials Application (Canada)? No Coordination: Intergroup(SWOG) Status: Closed Activation Date: September 20, 2017 , Closing Date: July 12, 2018 Chairs: (Canada) Dr. Natasha Leighl, University Health Network, 1(416) 946-4645 BRC6IA Phase III Randomized Study of Nivolumab plus Ipilimumab versus Nivolumab for Previously Treated Patients with Stage IV Squamous Cell Lung Cancer and No Matching Biomarker (Lung-Map Sub-Study)Eligibility: Patients must (1)be assigned to BRC6I, (2) not had prior treatment with an anti-PD-1, anti-PDL1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways,(3) not have an active, known, or suspected autoimmune disease,(4) not have any known allergy or reaction to any component of the nivolumab & ipilimumab formulations,(5) not have received systemic treatment with corticosteroids or other immunosuppressive medications within 14 D,(6)not have a known + test for HBV sAg or HCV antibody indicating acute or chronic infection,(7) not have known history of testing positive for HIV or known AIDS,(8) not have interstitial lung disease that is symptomatic or disease that may interfere with the detection or management of suspected drug-related pulmonary toxicity,(9) must also be offered participation in banking for future use of specimens,(10) see also common eligibility criteria of main BRC6 trial. Objectives: (1) to compare OS in patients with advanced stage refractory SCCA of the lung randomized to nivolumab plus ipilimumab vs nivolumab, (2) to compare investigator-assessed PFS in patients with advanced stage refractory SCCA of the lung randomized to nivolumab plus ipilimumab vs nivolumab,(3) to compare the response rates (confirmed and unconfirmed, complete and partial) per RECIST 1.1 among patients randomized to receive nivolumab plus ipilimumab vs nivolumab,(4) to compare the response rates (confirmed only, complete and partial) per RECIST 1.1 among patients randomized to receive nivolumab plus ipilimumab vs nivolumab, (5) to evaluate the frequency and severity of toxicities associated with nivolumab plus ipilimumab vs nivolumab, (6) to evaluate if there is an differential treatment effect on OS, IA-PFS, and Response by tumor PD-L1 expression status. NCT Registration ID (from clinicaltrials.gov): NCT02154490 Participation: NCI US Affiliation? Yes Clinical Trials Application (Canada)? No Coordination: Intergroup(SWOG) Status: Closed Activation Date: April 15, 2016 , Closing Date: April 23, 2018 Chairs: (Canada) Dr. Natasha Leighl, University Health Network, 1(416) 946-4645 BRC7INSIGNA: A Randomized, Phase III Study of Firstline Immunotherapy alone or in Combination with Chemotherapy in Induction/Maintenance or Post Progression in Advanced Nonsquamous Non-Small Cell Lung Cancer (NSCLC) with Immunobiomarker SIGNature-driven AnalysisEligibility: Patients must have histologically or cytologically confirmed stage IV non-squamous NSCLC (includes M1a, M1b, and M1c stage disease. Patients with T4NX disease (Stage IIIB) with nodule in ipsilateral lung lobe are eligible if they are not candidates for combined chemotherapy and radiation. Patients must have PD-L1 expression Tumor Proportion Score (TPS)greater than or equal to 1% in tumor cells. Patients must have measurable or non-measureable disease. Objectives: Co-primary objective is to evaluate overall survival (OS) in each of the 2 experimental arms (Arms A and B) to control (Arm C). To evaluate progression-free survival (PFS) for Arm C versus each of Arms A and B; best objective response rates for Arm C versus each of Arms A and B; to estimate toxicity within each of the treatment arms via the CTCAE criteria, compare outcomes b/w Arms A & B, and outcomes by treatment arm within subgroups defined by a cutpoint of PD-L1 expression at > 50%. NCT Registration ID (from clinicaltrials.gov): NCT03793179 Participation: Open to member centres NCI US Affiliation? Yes Clinical Trials Application (Canada)? Yes Coordination: Intergroup(ECOG-ACRIN) Status: Closed Activation Date: July 10, 2019 , Closing Date: March 01, 2024 Chairs: (Canada) Dr. Andrew Robinson, Cancer Centre of Southeastern Ontario at Kingston, 1(613) 549-6666 Ext. 8104 BRC8MRI Brain Surveillance Alone versus MRI Surveillance and Prophylactic Cranial Irradiation (PCI): A Randomized Phase III Trial in Small-Cell Lung Cancer (MAVERICK)Eligibility: Disease Related Criteria: a) Patient must have a histologically confirmed diagnosis of small-cell lung cancer(SCLC). b) Patient must have an MRI of the brain performed within 28 days prior to registration documenting no evidence of brain metastases or leptomeningeal disease. Patient also must not have a history of brain metastases or leptomeningeal disease. Prior/Concurrent Therapy Criteria: a) Immunotherapy concurrent with and/or adjuvant to first-line therapy is allowed at the discretion of the treating pysician. b) All adverse events from prior treatment must have resolved to Grade 2 (CTCAE Version 5.0) prior to randomization. c) Patient must have had a response to first-line therapy and no evidence of progression in opinion of the treating investigator. d) No more then 8 weeks elapsed between D1 of last cycle of chemotherapy and radomization e) Patient must not have received prior radiotherapy to the brain or WBRT. Objectives: Primary Objective: To evaluate whether overall survival (OS) with MRI surveillance alone is not inferior to MRI surveillance combined with prophylactic cranial irradiation (PCI) for the treatment of small cell lung cancer (SCLC). Secondary Objectives: To compare cognitive failure free survival (CFFS) rate up to 12 months after randomization between the arms. To compare brain-metastasis-free survival between the arms. To compare OS between the arms within the subgroups of patients with limited-stage and extensive-stage disease. To compare cognitive failure free survival (CFFS) rates at the assessment times between the arms. To compare the cumulative incidence of cognitive failure with death as a competing risk between the arms. To compare the frequency and severity of toxicities between the two arms. Additional Objectives: To collect blood for banking. NCT Registration ID (from clinicaltrials.gov): NCT04155034 Participation: Open to member centres NCI US Affiliation? Yes Clinical Trials Application (Canada)? Yes Coordination: Intergroup(SWOG) Status: Open Activation Date: May 27, 2020 Chairs: (Canada) Dr. Jonathan Greenland, Dr. H. Bliss Murphy Cancer Centre, 1(709) 777-7802 MELANOMA STUDIESME10Phase III Randomized Study of Four Weeks High Dose IFN-a2b in Stage T2b N0, T3a-bN0, T4a-b N0, and T1-4, N1a, 2a (microscopic) MelanomaEligibility: Patients with resected melanoma in the following categories: (1) T3-N0 (1.5-4 mm), (2) T4-N0 (> 4 mm), (3) T1-4 (microscopic, one lymph node positive). Objectives: To compare the effect of treatment with four weeks of high dose IFN alpha-2b versus observation on relapse free survival and overall survival. Also, toxicities and quality-adjusted survival will be compared in the two groups. NCT Registration ID (from clinicaltrials.gov): NCT00003641 Participation: Open to member centres NCI US Affiliation? Yes Clinical Trials Application (Canada)? No Coordination: Intergroup(ECOG) Status: Closed Activation Date: September 14, 1999 , Closing Date: October 26, 2010 Chairs: (Canada) Dr. Michael Smylie, Cross Cancer Institute, 1(780) 432-8757 ME13A Randomized Phase III Trial of the Duration of Anti-PD-1 Therapy in Metastatic Melanoma (STOP-GAP)Eligibility: Patients with unresectable / metastatic (stage III or stage IV) melanoma, who are eligible to receive Health Canada approved, publically-funded PD-1 inhibitors. Objectives: PRIMARY: To determine whether the Overall Survival (OS) of patients randomized to intermittent PD-1 inhibitor therapy is non-inferior to that of patients randomized to continuous PD-1 inhibitor therapy, in unresectable / metastatic (stage III or stage IV) melanoma. SECONDARY OBJECTIVES: (1) Progression-Free Survival, (2) Response rate and duration of response, (3) Adverse Events profile, (4) Quality of Life and (5) Economic Evaluation NCT Registration ID (from clinicaltrials.gov): NCT02821013 Participation: Open to member centres NCI US Affiliation? No Clinical Trials Application (Canada)? No Coordination: Intergroup(CCTG) Status: Open Activation Date: July 04, 2016 Chairs: (Canada) Dr. Ian Watson, Canada Research Chair II in Functional Genomics of M, 1(514) 398-3399 (Canada) Dr. Xinni Song, Ottawa Hospital Research Institute, 1(613) 737-7700 Ext. 70208 ME13LA Biomarker Sub-study of the CCTG ME.13 Duration of Anti PD-1 Therapy in Metastatic Melanoma STOP-GAP TrialEligibility: Participants of the main ME.13 trial enrolled at a Canadian centre who consent to submit a blood sample for buffy-coat and at least one additional biospecimen category. Objectives: PRIMARY OBJECTIVE: To profile human bodily material (HBM) before, during and/or post-treatment with immune-checkpoint inhibitors (ICI) to characterize predictive biomarkers of key clinical outcomes of response, progression free and overall survival, and immune related toxicity during continuous and discontinuous ICI therapy regimens from the ME13 clinical trial. SECONDARY OBJECTIVES: (1) To identify spatial relationships between immune and melanoma cells in the pre-treatment tumour microenvironment (TME) that predict clinical outcomes; (2) To define mRNA expression and epigenetic changes in single exhausted CD8+ T cells and other immune cells that correlate with ICI response during continuous vs. intermittent ICI treatment; (3) To determine whether multi-dimensional molecular profiling of melanomas and circulating immune cells can identify a subset of markers to best predict clinical outcomes. Participation: Open to member centres NCI US Affiliation? No Clinical Trials Application (Canada)? No Coordination: NCIC CTG Status: Open Activation Date: November 14, 2023 Chairs: (Canada) Dr. Ian Watson, Canada Research Chair II in Functional Genomics of M, 1(514) 398-3399 ME15Melanoma Margins Trial: A Phase III, Multi-centre, Multi-national Randomized Control Trial Investigating 1cm vs 2cm Wide Excision Margins for Primary Cutaneous Melanoma (MelMarT-II)Eligibility: Patients are eligible if all the following requirements are met: 18 years or older, Histologically confirmed, primary invasive cutaneous melanoma: AJCC 8th edition Stage IIA-IIC (pT2b-pT4b), ECOG performance status 0-1 at randomisation, able to give informed consent, and comply with protocol treatment and follow up, randomisation and treatment must be performed within 120 days of diagnosis, patients must have no previous malignancy or primary except low-risk non-melanoma skin cancer (unless in remission and >5 years since diagnosis). Objectives: This study will determine whether there is a difference in disease free survival for patients treated with either a 1cm excision margin or 2cm margin for clinical stage II (pT2b-pT4b) primary cutaneous melanoma (AJCC 8th edition).The study is designed to be able to prove or disprove that there is no difference in risk of melanoma recurrence between the two groups of patients. This study is designed to show that the risk of long-term pain associated with surgery can be reduced. If the study achieves its primary objective and demonstrates safety with a narrower margin, then we will also be able to determine how much of an impact the narrower excision has on patients in terms of improved quality of life and reduced side effects from the surgery and melanoma disease. This trial will also evaluate and determine the economic impact of narrower excision margins on the health services and society in general. NCT Registration ID (from clinicaltrials.gov): NCT03860883 Participation: Open to member centres NCI US Affiliation? No Clinical Trials Application (Canada)? No Coordination: Intergroup(MASC) Status: Open Activation Date: July 30, 2020 Chairs: (Canada) Dr. Frances C. Wright, Odette Cancer Centre, 1(416) 480-5000 Ext. 3835 ME17A Phase II Randomized Trial of LND101 for Fecal Microbiota Transplantation in Combination with Immune Checkpoint Blockade in Patients with Advanced MelanomaEligibility: MAIN INCLUSION CRITERA: Adults over 18 years of age with histological diagnosis of cutaneous melanoma or melanoma of unknown primary; Confirmed stage IV or advanced unresectable melanoma; Must have measurable disease; ECOG 0-2; No prior ICB treatment for advanced unresectable or metastatic disease; Able to ingest capsules. MAIN EXCLUSION CRITERIA: Antibiotic treatment in last 14 days; Corticosteroid use of > 10mg per day; Any absolute contraindications to FMT ; Active infections requiring antibiotic treatment. Objectives: PRIMARY: Progression Free Survival (PFS) (per RECIST 1.1 and iRECIST) in standard of care ICB arm vs. standard of care ICB + FMT arm. SECONDARY: Compare treatment arms with respect to Overall Survival (OS), Objective Response Rate (ORR), and safety and tolerability. EXPLORATORY: To evaluate acquired donor-host similarity and its association with PFS in the FMT treatment arm; to evaluate engraftment and its association with progression-free survival in the FMT treatment arm; to evaluate the impact of FMT on the gut microbiota, gut metabolome and systemic immune response. NCT Registration ID (from clinicaltrials.gov): NCT06623461 Participation: Open to member centres NCI US Affiliation? No Clinical Trials Application (Canada)? Yes Coordination: NCIC CTG Status: Planned Chairs: (Canada) Dr. Bertrand Routy, CHUM-Centre Hospitalier de l'Universite de Montreal, (514) 890-8000 (Canada) Dr. Rahima Jamal, CHUM-Centre Hospitalier de l'Universite de Montreal, 1(514) 890-8444 (Canada) Dr. Arielle Elkrief, CHUM-Centre Hospitalier de l'Universite de Montreal, (514) 890-8000 (Canada) Dr. John Lenehan, London Regional Cancer Program, (519) 685-8640 MEC3A Phase III Randomized Study of Adjuvant Ipilimumab Anti-CTLA4 Therapy versus High-Dose Interferon a-2b for Resected High-Risk MelanomaEligibility: Patients enrolled in this study must have a diagnosis of primary cutaneous melanoma (high risk stage IIIB - IV as per AJCC Melanoma Staging System), and must have completely surgically resected disease at baseline. Patients must have been surgically rendered free of disease with negative margins, and must have a disease free status documented by a complete physical examination and imaging studies within 4 weeks prior to randomization. Some patients with disease recurrence after adequate surgical excision of the original primary melanoma are allowed as well, as specified in the protocol. A total of 1500 patients will be enrolled over 3.3 years. Accrual rate is expected to be 38 per month, and with additional follow up time, a total duration of study is expected to be less than 6 years. Objectives: Primary Objectives: " To evaluate recurrence-free survival (RFS) between patients randomized to receive post-operative adjuvant ipilimumab given at either 10 mg/kg (high dose ipilimumab; HIP) or 3 mg/kg (low dose ipilimumab: LIP) versus those randomized to receive HDI utilizing a hierarchical design assessing HIP versus HDI first and LIP versus HDI second (if the first comparison is significant). " To evaluate overall survival (OS) between patients randomized to receive post-operative adjuvant ipilimumab given at either 10 mg/kg (HIP) or 3 mg/kg (LIP) versus those randomized to receive HDI utilizing a hierarchical design assessing HIP versus HDI first and LIP versus HDI second (if the first comparison is significant). Secondary Objectives: " To evaluate safety and tolerability of post-operative adjuvant ipilimumab therapy given at either 10 mg/kg (HIP) or 3 mg/kg (LIP). NCT Registration ID (from clinicaltrials.gov): NCT01274338 Participation: Open to member centres NCI US Affiliation? Yes Clinical Trials Application (Canada)? Yes Coordination: Intergroup(ECOG) Status: Closed Activation Date: October 02, 2012 , Closing Date: August 15, 2014 Chairs: (Canada) Dr. Teresa M. Petrella, Odette Cancer Centre, 1(416) 480-4270 MEC5A Phase III Randomized Trial Comparing Physician/Patient Choice of Either High Dose Interferon or Ipilimumab to MK-3475 (Pembrolizumab) in Patients with High Risk Resected MelanomaEligibility: Patients enrolled in this study must have completely resected melanoma of cutaneous origin (stage IIIA (N2a), IIIB, IIIC, or Stage IV) or of unknown primary. Patients with melanoma of mucosal or other non-cutaneous origin are eligible except for those with melanoma of ocular origin. Patients with a history of brain metastases are ineligible. For all patients, all disease must have been resected with negative pathological margins and no clinical radiologic or pathological evidence of any incompletely resected melanoma. Patients must be registered with 98 day of the last surgery performed to render the patient free of disease. Accrual rate is expected to be 45 patients per month with a total of 1240 patients enrolled in less than 2.5 years. Objectives: Primary Objectives: a.Compare overall survival (OS) of patients with resected Stage III and IV melanoma treated with high dose interferon alfa-2b versus MK-3475 (pembrolizumab) b.Among patients who are PD-L1 positive, to compare OS of patients with resected Stage III and IV melanoma treated with high dose interferon alfa-2b versus MK-3475 (pembrolizumab) c.Compare relapse-free survival (RFS) of patients with resected Stage III and IV melanoma treated with high dose interferon alfa-2b to MK-3475 (pembrolizumab) d.Among patients who are PD-L1 positive, to compare RFS of patients with resected Stage III and IV melanoma treated with high dose interferon alfa-2b to MK-3475 (pembrolizumab) Secondary Objectives: a. Estimate OS and RFS for patients who are PD-L1 negative or PD-L1 indeterminate in this population. b. Compare OS and RFS of patients between the two regimens within PD-L1 positive and negative subgroups and to look at the interaction between PD-L1 and treatment arm. NCT Registration ID (from clinicaltrials.gov): NCT02506153 Participation: Open to member centres NCI US Affiliation? Yes Clinical Trials Application (Canada)? Yes Coordination: Intergroup(SWOG) Status: Closed Activation Date: January 15, 2016 , Closing Date: November 02, 2017 Chairs: (Canada) Dr. Teresa M. Petrella, Odette Cancer Centre, 1(416) 480-4270 MEC6A Randomized Phase II Trial of Adjuvant Nivolumab with or without Cabozantinib in Patients with Resected Muscosal MelanomaEligibility: Histologically proven mucosal melanoma by local pathology; central PD-L1 tissue tumour submission; Resected R0 or R1 disease; non-resected R2 or metastatic disease that is assessable and measurable; no prior systemic checkpoint inhibitor therapy of mucosal melanoma; age 18 or older. Objectives: To compare the efficacy of adjuvant nivolumab (480mg q4 weeks) versus nivolumab plus cabozantinib (40 mg daily) in patients with mucosal melanoma. The primary objective will be measured as a comparison of duration of recurrence free survival (RFS) between the arms. Secondary objectives: OS, adverse effects by treatment arm, correlation between PD-L1 expresssion in tumour cells with RFS and OS; to evaluate ORR, DOR, PFS and OS of nivo plus cabo in patients who cannot undergo gross total resection of disease or have metastatic disease at baseline. NCT Registration ID (from clinicaltrials.gov): NCT05111574 Participation: Open to member centres NCI US Affiliation? Yes Clinical Trials Application (Canada)? Yes Coordination: Intergroup(ALLIANCE) Status: Open Activation Date: July 08, 2022 Chairs: (Canada) Dr. Marcus Butler, University Health Network, 1(416) 946-4501 Ext. 5485 OTHERS STUDIESPM1Canadian Profiling and Targeted agent Utilization tRial (CAPTUR). A Phase II Basket Trial.Eligibility: Patients with incurable metastatic solid tumors, multiple myeloma, or B cell non-Hodgkin lymphoma (NHL - excluding CLL, SLL and HCL), who have no standard treatment options known to prolong life (or may have refused such option(s)), and have an "actionable" genomic variant known to be a target of a Health Canada-approved anticancer drug or to predict sensitivity to a Health Canada- approved anticancer drug. Objectives: PRIMARY: To evaluate the objective response rate (based on disease-appropriate objective criteria) of targeted drugs matched to pre-specified molecular aberrations (at the level of the gene) within a tumor type, among patients with incurable metastatic solid tumors, multiple myeloma, or B cell non-Hodgkin lymphoma (NHL) with an "actionable" genomic variant known to be a target of a Health Canada-approved anticancer drug or to predict sensitivity to a Health Canada- approved anticancer drug. SECONDARY: (1) To evaluate the safety of commercially available anticancer agents in patients enrolled on CAPTUR; (2) To evaluate progression free survival (PFS) based on disease-appropriate objective criteria. NCT Registration ID (from clinicaltrials.gov): NCT03297606 Participation: Limited to invited centres NCI US Affiliation? No Clinical Trials Application (Canada)? Yes Coordination: Intergroup(CCTG) Status: Open Activation Date: October 06, 2017 Chairs: (Canada) Dr. Lillian Siu, Univ. Health Network-OCI/Princess Margaret Hospital, 1(416) 946-2911 (Canada) Dr. Daniel John Renouf, BCCA - Vancouver Cancer Centre, 1(604) 877-6000 Ext. 672357 PM1SInsight of the Use and Value of Genomic Analysis in Cancer Patients: A Pan-Canadian Survey of Oncologists and PatientsEligibility: Patients with incurable metastatic solid tumors, multiple myeloma, or B cell non-Hodgkin lymphoma (NHL - excluding CLL, SLL and HCL), who have no standard treatment options known to prolong life (or may have refused such option(s)), and will haveundergone standard testing as indicated by local/provincial practice for diagnosis Medical oncologists must be QIs or SIs active on the PM.1 Participants List and must be from a site which is participating on the PM.1/CAPTUR trial.. Objectives: Primary Objective 1. To determine how Canadian oncologists, from academic cancer centres, use Next-Generation Sequencing (NGS) tests to evaluate patients with metastatic disease who have already undergone standard of care diagnostic testing and inform treatment recommendations, pre- and post-testing. Secondary Objectives 1. To determine patient's satisfaction with their decision-making using a validated tool, pre- and post-NGS testing 2. To obtain feedback from oncologists on the decision impact of NGS and requirements to increase the usage of precision medicine NCT Registration ID (from clinicaltrials.gov): no NCT Participation: Limited to invited centres NCI US Affiliation? No Clinical Trials Application (Canada)? No Coordination: NCIC CTG Status: Closed Activation Date: June 08, 2020 , Closing Date: May 31, 2022 Chairs: (Canada) Dr. Philippe Bedard, University Health Network, 1(416) 946-4501 Ext. 4534 PM2Canadian Initiative to Measure, Predict and Assess Cancer Treatment Outcomes in Patients Treated with Immuno-Oncotherapeutics (CAN-IMPACT-IO)Eligibility: CAN-IMPACT-IO is a standalone study of the CCTG, to be performed in collaboration with the Marathon of Hope Cancer Centres Network (MOHCCN) and Princess Margaret Cancer Consortium (PM2C), to perform fresh tumor biopsies for whole genome and transcriptome sequencing (WGTS) analysis for patients enrolled in a specified list of immuno-oncology (IO) therapeutic trials with immune checkpoint inhibitors targeting PD1/PDL1 as single agents or in combination currently active in CCTG. Objectives: Primary Objective -To profile human bodily material (HBM) from patients treated in a specified list of IO therapeutic trials currently active in CCTG, using WGTS either before treatment, during treatment or at time of disease progression with IO to uncover prognostic biomarkers as well as predictive biomarkers of response or resistance. Secondary Objectives -To contribute clinically annotated WGTS data to a unique MOHCCN cohort of 15,000 Canadian cancer patients via PM2C-led Pan-Canadian projects. Tertiary Objectives -To evaluate immune cell populations present in tumoral areas and in the tumor microenvironment (TME) using multiplexed immunohistochemistry (IHC) in a subset of patients treated in a specified list of IO therapeutic trials currently active in CCTG. NCT Registration ID (from clinicaltrials.gov): NCT06630273 Participation: Open to member centres NCI US Affiliation? No Clinical Trials Application (Canada)? No Coordination: NCIC CTG Status: Open Activation Date: October 08, 2024 Chairs: (Canada) Dr. Anna Spreafico, University Health Network, 1(416) 946-4501 Ext. 4012 (Canada) Dr. Philippe Bedard, University Health Network, 1(416) 946-4501 Ext. 4534 SARCOMA STUDIESSR7A Randomized Phase III Study of Neoadjuvant Chemotherapy Followed by Surgery versus Surgery Alone for Patients with High Risk RetroPeritoneal Sarcoma (STRASS 2)Eligibility: Histologically proven primary high risk leiomyosarcoma (LMS) or Liposarcoma (LPS) of retroperitoneal space or infra-peritoneal spaces of pelvis, unifocal resectable tumour, radiologically measurable disease (RECIST 1.1), 18 years old or older, WHO ps 0-2, adequate haematological and organ function, ASA < 3, negative serum pregnancy test, consent to use highly effective birth control measures throughout duration of study and for at least 6 months after last treatment. No sarcoma originating from bone structure, abdominal or gynecological viscera, no metastatic disease, no previous treatment to present tumour, no hypersensitivity to doxorubicin, ifosfamide, dacarbazine or any of their metabolites/excipients, no recent or uncontrolled cardiac disease, no active or uncontrolled infections, and/or no live vaccines within 30 days of study entry. Objectives: The primary objective of this study is to assess whether preoperative chemotherapy, as an adjunct to curative-intent surgery, improves the prognosis of patients with high risk de-differentiated liposarcoma (DDLPS) and leiomyosarcoma (LMS) as measured by disease-free survival. NCT Registration ID (from clinicaltrials.gov): NCT04031677 Participation: Open to member centres NCI US Affiliation? No Clinical Trials Application (Canada)? No Coordination: Intergroup(EORTC) Status: Open Activation Date: February 01, 2021 Chairs: (Canada) Dr. Rebecca Gladdy, Sinai Health System, 1(416) 586-8440 SRC6Pazopanib Neoadjuvant Trial in Non-Rhabdomyosarcoma Soft Tissue Sarcomas (PAZNTIS): A Phase II/III Randomized Trial of Preoperative Chemoradiation or Preoperative Radiation Plus or Minus PazopanibEligibility: Newly diagnosed and histopathologically confirmed, potentially resectable NRSTS of the extremity and trunk. Patients must be 2 years or older at the time of the biopsy that established the diagnosis of NRSTS. Objectives: Primary:Determine feasibility of pazopanib + radiation or chemoradiation (phase II. Compare rates of complete pathologic response in patients receiving radiation or chemoradiation +/- pazopanib (phase II).Compare rates of EFS in patients receiving radiation +/- pazopanib (phase III) Secondary: Estimate and compare rates of local, regional and distant failure, DFS and OS. Compare patterns of recurrence. Define toxicities of pazopanib in combination with radiation or chemoradiation. NCT Registration ID (from clinicaltrials.gov): NCT02180867 Participation: Open to member centres NCI US Affiliation? Yes Clinical Trials Application (Canada)? Yes Coordination: Intergroup(COG) Status: Closed Activation Date: December 05, 2014 , Closing Date: October 22, 2018 Chairs: (Canada) Dr. Mohamed A.M. Akra, CancerCare Manitoba, 1(204) 787-1210 SRC8A Randomized Phase III Trial of Doxorubicin + Pembrolizumab versus Doxorubicin Alone for the Treatment of Undifferentiated Pleomorphic Sarcoma (UPS) and Related Poorly Differentiated SarcomasEligibility: Patient must be ? 18 years of age. Must have a confirmed histopathologic diagnosis of Undifferentiated Pleomorphic Sarcoma (UPS) or a related poorly differentiated sarcoma. must have metastatic or unresectable sarcoma. Patient must have an ECOG Performance Status 0-1. Objectives: PRIMARY:To assess whether the combination of doxorubicin and pembrolizumab will improve progression free survival (PFS) in UPS and related poorly differentiated sarcomas relative to doxorubicin alone. SECONDARY:To assess whether the combination of doxorubicin and pembrolizumab vs the re-introduction of pembrolizumab in the doxorubicin alone arm at disease progression (i.e., upfront pembrolizumab vs second line pembrolizumab) improves overall survival (OS). -To evaluate the safety and tolerability in each treatment arm -To quantify overall response rate (ORR) and durability of response (DOR) in each treatment. NCT Registration ID (from clinicaltrials.gov): NCT06422806 Participation: NCI US Affiliation? Yes Clinical Trials Application (Canada)? Yes Coordination: Intergroup(ECOG-ACRIN) Status: Planned Chairs: (Canada) Dr. Shantanu Banerji, CancerCare Manitoba, 1(204) 787-8959 SYMPTOM CONTROL STUDIESIC8COV-IMMUNO - A Randomized, Phase III Trial of Immunization with IMM-101 versus Observation for the Prevention of Severe Respiratory and COVID-19 Related Infections in Cancer Patients at Increased Risk of ExposureEligibility: Patients must be: -undergoing (or be planned to undergo) active treatment for one or more solid malignancy, lymphoma or myeloma, requiring them to present to the hospital or cancer clinic at least twice/month for assessments and/or treatments, anticipated for at least 3 months. - have one or more of the following risk factors for a severe COVID-19 infection: Age > 65 years old; Hypertension (on medications); Type 1 or 2 Diabetes (on medication); A relevant chronic condition as per the investigator based on the medical record including heart, lung, liver and/or serious kidney disease; receiving systemic therapy; Body Mass Index > 40; Living in a nursing home or long term care facility. - Age 18 or greater and an ECOG PS of 0-2 Objectives: Primary objective: to investigate the effectiveness of IMM 101 at preventing "influenza-like illnesses" (ILI), as defined by the WHO, OR a confirmed viral/bacterial respiratory infection (via microbiology or radiography), AND that results in a change or delay in a priori planned cancer treatment or requirement for an unscheduled medical assessment (i.e. emergency room visit, family physician assessment, etc.), hospitalization, or death compared to control subjects. Numerous Secondary and Tertiary/Exploratory Objectives planned. NCT Registration ID (from clinicaltrials.gov): NCT04442048 Participation: Limited to invited centres NCI US Affiliation? No Clinical Trials Application (Canada)? Yes Coordination: NCIC CTG Status: Closed Activation Date: June 25, 2020 , Closing Date: May 14, 2021 Chairs: (Canada) Dr. Rebecca Ann Auer, Ottawa Hospital Research Institute, 1(613) 737-7700 Ext. 72791 ICC1NCI COVID-19 in Cancer Patients Study (N-CCaPS): A Longitudinal Natural History StudyEligibility: Patients must have a prior or current cancer diagnosis, that fits into one of the following categories: - Patient is receiving active treatment (current or within the last 6 weeks) for metastatic cancer - Patient is receiving adjuvant treatment + had IV chemotherapy, immuno or targeted therapy, endocrine therapy, or RT in the last 6 weeks - Patient received ASCT, CAR-T or modified cell therapy at any time - Patient is receiving treatment or prophylaxis or host disease, or received bone marrow transplant within the past 2 years. Patients must have had a positive COVID-19 test within the last 14 days using any specimen source. Patients with brain mets or HIV are eligible. Co-enrollment on other clinical trials is allowed. Objectives: 1. Characterize patient factors, such as pre-existing comorbidities, cancer type and treatment, and demographic factors, associated with short- and long-term outcomes of COVID-19, including severity and fatality, in cancer patients undergoing treatment. 2. Describe cancer treatment modifications made in response to COVID-19, including dose adjustments, changes in symptom management, or temporary or permanent cessation. 3. Evaluate the association of COVID-19 with cancer outcomes in patient subgroups defined by clinico-pathologic characteristics. 4. Correlative study objectives by collection, storage, and research of blood specimens and radiological images. NCT Registration ID (from clinicaltrials.gov): NCT04387656 Participation: Open to member centres NCI US Affiliation? Yes Clinical Trials Application (Canada)? No Coordination: Intergroup(NCRI) Status: Closed Activation Date: June 18, 2020 , Closing Date: February 01, 2022 Chairs: (Canada) Dr. Nathalie Daaboul, Hopital Charles LeMoyne, 1(450) 466-5000 SC26Emotion and Symptom-focused Engagement (EASE): A Multi-Site Randomized Controlled Trial of an Intervention for Individuals with Acute LeukemiaEligibility: Patients with newly-diagnosed acute leukemia (AL) within 2 weeks of admission who will be receiving induction chemotherapy with curative intent. Patients must be fluent in English and must pass the cognitive screening test. Objectives: PRIMARY OBJECTIVE: To determine the effectiveness of EASE vs. usual care (UC) to reduce psychological distress and physical symptom severity in adults with newly diagnosed acute leukemia after 8 weeks of implementation. SECONDARY OBJECTIVE: (1) To determine the effectiveness of EASE vs. UC to reduce psychological distress and physical symptom severity after 4 and 12 weeks, 6 months, and 1 year; (2) to determine the effects of EASE vs UC on other domains of health-related quality of life; and (3) to conduct post-trial, an economic analysis of EASE to determine the cost-effectiveness of EASE delivery in relation to its effect on reduction of distress in individuals with AL compared to UC. NCT Registration ID (from clinicaltrials.gov): NCT04224974 Participation: Limited to invited centres NCI US Affiliation? No Clinical Trials Application (Canada)? No Coordination: NCIC CTG Status: Open Activation Date: December 23, 2019 Chairs: (Canada) Dr. Gary Rodin, University Health Network, (416) 946-4504 (Canada) Dr. Camilla Zimmermann, University Health Network, 1(416) 946-2135 SC27Living with Cancer in the Time of COVID-19: A Cohort Study of the Impact of the COVID-19 Pandemic on Cancer Patients During Treatment and SurvivorsEligibility: >=18 years of age: any cancer diagnosis in the last 10 years, any stage; must be able to read/ write english or french Objectives: Primary objectives 1. Describe the pattern of psychosocial and physical symptom severity, and QOL over time and differences by sub-groups (e.g., age, gender, cancer stage) 2. Assess participants' perceptions of their experience and satisfaction of cancer care over time 3. Identify the coping strategies, and health and safety actions used by patients and survivors during cancer diagnosis, treatment, and recovery in the context of COVID-19 Secondary objectives 4. Examine factors associated with psychosocial and physical symptom severity, poor QOL and other clinical outcomes (e.g., COVID-19 status, hospitalization, and mortality). 4a. Explore effect modification by selected subgroups (e.g., age, sex, gender, cancer stage) NCT Registration ID (from clinicaltrials.gov): no NCT Participation: Limited to invited centres NCI US Affiliation? No Clinical Trials Application (Canada)? No Coordination: NCIC CTG Status: Closed Activation Date: June 30, 2020 , Closing Date: August 16, 2022 Chairs: (Canada) Dr. Linda Carlson, Tom Baker Cancer Centre - Cancer Control Alberta, 1(403) 355-3207 SC28The SEAMLESS Study: A Pragmatic Multi-Site Randomized Waitlist-Controlled Trial of a Smartphone App-Based Mindfulness Intervention for French and English Speaker Cancer SurvivorsEligibility: ? Adult ? 18 years ? Diagnosed with any type of cancer (stages I-IV) ? Completed primary treatment (i.e. surgery, chemotherapy, radiation therapy) at least 2 weeks (14days) prior. Note: ongoing maintenance therapy, hormone-blocking therapies, intermittent bone-modifying agents, herceptin and targeted therapy with trastuzumab are not exclusionary Objectives: ? Evaluate the effectiveness of the 4-week MBCS Journey intervention in decreasing total symptoms of stress in adult PLWC at 3 months from randomization ? ? Determine the impact of the 4-week MBCS Journey intervention on anxiety, depression, fatigue, and overall physical functioning and quality of life in adult PLWC post-treatment, immediately after the therapeutic intervention NCT Registration ID (from clinicaltrials.gov): NCT05470010 Participation: Open to member centres NCI US Affiliation? No Clinical Trials Application (Canada)? No Coordination: NCIC CTG Status: Open Activation Date: August 29, 2023 Chairs: (Canada) Dr. Linda Carlson, Tom Baker Cancer Centre - Cancer Control Alberta, 1(403) 355-3207 SC29A Randomized Phase III Study Comparing Stereotactic Body Radiotherapy (SBRT) versus Conventional Palliative Radiotherapy (CRT) for Participants with Painful Non-Spine Bone MetastasesEligibility: Histologic confirmation of cancer Patient with a dominant painful non-spine bone metastasis and a worst minimum pain score of 2 using the ESAS attributed to the dominant site. Suitable for protocol defined SBRT and EBRT Objectives: The primary objective is to compare conventional EBRT to SBRT for 3-month complete pain response (CPR) administered to the dominant site of pain using the pain score question from the ESAS instrument and analgesic intake as recommended by the ICPRE NCT Registration ID (from clinicaltrials.gov): NCT06391242 Participation: Open to member centres NCI US Affiliation? No Clinical Trials Application (Canada)? No Coordination: NCIC CTG Status: Open Activation Date: June 26, 2024 Chairs: (Canada) Dr. Timothy Nguyen, London Regional Cancer Program, (519) 685-8600 (Canada) Dr. Arjun Sahgal, Odette Cancer Centre, (416) 480-4834 SC30Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy Platform Trial - RATIONAL-PTEligibility: Objectives: Participation: NCI US Affiliation? No Clinical Trials Application (Canada)? No Coordination: Intergroup(AUMO) Status: Planned Chairs: (Canada) Dr. Alfonso Rivera Duarte, Regional Health Authority B, Zone 2, 1(506) 648-7109 SC31Using SMART to optimize the stepped care delivery of TEMPO ? a Tailored, dyadic, wEb-based physical activity and self-Management PrOgram for men with prostate cancer and their caregivers (TEMPO)Eligibility: Objectives: Participation: NCI US Affiliation? No Clinical Trials Application (Canada)? No Coordination: Intergroup(MUHC) Status: Planned Chairs: (Canada) Dr. Sylvie Lambert, St. Mary's Hospital, (514) 761-6131 |
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