Gynecologic Disease Site

Gynecologic

ID Sort	Study Title	Status Sort
VU2	STRatIfication of Vulvar squamous cell carcinoma by HPV and p53 status to guide Excision: STRIVE Study Read More Complexity Level: 2 Eligibility: Histologically confirmed primary diagnosis of vulvar squamous cell carcinoma (VSSC). Surgically staged FIGO I-II VSCC. Vulvar resection according to standard of care guidelines. Post-operative margin assessment of tumour clearance, dVIN, and p53 status. Participants must be >/= 18 years old. Participants must enroll within 60 days of primary vulvar surgery. Objectives: Primary: Estimate the 3-year local recurrence rates in participants with HPV-indepenent (HPV-I) and HPV-associated (HPV-A) VSCC surgically managed based on dVIN/p53 status and tumour margin clearance. Secondary: Estimate RFS, DSS and OS in both the HPV-I and HPV-A cohorts. Estimate health economic impact of surgical management based on molecular stratification and margin status in both cohorts. Describe PROs in both cohorts. Estimate recurrence rates of vulvar dVIN and/or p53abn (HPV-I cohort only). Exploratory: Identify prognostic or predictive molecular biomarkers in HPV-I and HPV-A VSCC. NCT Registration ID (from clinicaltrials.gov): NCT06358469 Participation: Open to member centres NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: CCTG Led Trial Status: Planned Chair: (Canada) Dr. Amy Jamieson, University of British Columbia, (604) 729-1258, (Canada) Dr. Jessica McAlpine, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2395	Planned
CX6 (GINECO CE106)	International Validation Study of Sentinel Node Biopsy in Early Cervical Cancer SENTICOL III An international study is to find out, by comparing two groups of patients, if the "sentinel node" technique is as effective as the lymph node dissection with fewer complications. Read More Complexity Level: 2 Eligibility: - With squamous or adenocarcinoma of the cervix (proven by biopsy or cone biopsy), - Stage Ia1 with lymphovascular emboli, Ia2, Ib1 IIa1, Ib2 (clinical stage) of the 2018 FIGO classification (see appendix 1), - Maximum diameter . 40 mm by clinical examination and/or magnetic resonance imaging (MRI), - No suspicious node on pelvic MRI with an exploration up to the left renal vein (according to RECIST 1.1), Objectives: - To assess that Disease Free Survival (DFS) is similar between pN0 patients after SLN biopsy versus SLN biopsy + PLN - To assess a superiority of SLN biopsy for quality of life (HR-QoL) NCT Registration ID (from clinicaltrials.gov): NCT03386734 Participation: Open to member centres NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: Intergroup Led Trial Status: Open to Accrual Activation Date: July 24, 2020 Chair: (Canada) Dr. Vanessa Samouelian, CHUM-Centre Hospitalier de l'Universite de Montreal, (514) 890-8444	Open to Accrual
EN10	A Phase II Study of Tailored Adjuvant Therapy in POLE-mutated and p53-wildtype/NSMP Early Stage Endometrial Cancer (RAINBO BLUE & TAPER) This protocol tests de-escalated adjuvant treatment in patients with POLE-mutated or p53wt/NSMP (p53 wildtype/no specific molecular profile) in early-stage endometrial cancer (EC). The purpose of the study is to identify women who may not require additional treatment or may require less treatment because they are at such a low risk of recurrence. Read More Complexity Level: 2 Eligibility: Sub-study A, Cohort A1: with early-stage POLE-mutated EC; Sub-study A, Cohort A2-Exploratory: with higher-risk POLE-mutated EC; Sub-study B: with p53wt/NSMP ER+ EC Objectives: Primary Objective: Estimate the rate of pelvic recurrence at 3 years in patients who are treated with a de-escalated adjuvant treatment directed by tumour molecular status NCT Registration ID (from clinicaltrials.gov): NCT05640999 Participation: Open to member centres NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: CCTG Led Trial Status: Open to Accrual Activation Date: December 19, 2022 Chair: (Canada) Dr. Kathy Han, University Health Network, (416) 946-4501 Ext. 2919, (Canada) Dr. Jessica McAlpine, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2395	Open to Accrual
EN11 (RAINBO GREEN)	RAINBO: Refining Adjuvant treatment IN endometrial cancer Based On molecular features, TransPORTEC platform trials - The MMRD-GREEN trial Tailoring Therapy in Post-surgical Patients with Endometrial Cancer Read More Complexity Level: 2 Eligibility: Histologically confirmed diagnosis of EC of the following histologic subtypes: endometrioid endometrial carcinoma, serous endometrial carcinoma, uterine clear cell carcinoma, dedifferentiated and undifferentiated endometrial carcinoma, uterine carcinosarcoma, and mixed endometrial carcinomas of the aforementioned histotypes.Full molecular classification performed following the diagnostic algorithm described in WHO 2020. TLH-BSO or TAH-BSO with or without lymphadenectomy or sentinel node biopsy, without macroscopic residual disease after surgery. Molecular classification: MMRd EC (POLE status must be determined, and must be wildtype (or non-pathogenic) for inclusion.) Objectives: 2.1. Primary objective • 3-year RFS 2.2. Secondary objectives • RFS median and at 5 years • Vaginal RFS, pelvic RFS, distant metastasis free-survival (median, 3-year, 5-year) • Disease-specific survival (median, 3-year, 5-year) • OS (median, 3-year, 5-year) • HRQoL (EORTC QLQC30 and QLQEN24) • Safety & tolerability (NCI-CTC grade 3-5) • Explorative translational research , such as analysis PD-L1 positive subgroup (using SP263 assay (>1% and 5%). NCT Registration ID (from clinicaltrials.gov): NCT05255653-2 Participation: Open to member centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Open to Accrual Activation Date: July 07, 2023 Chair: (Canada) Dr. Stephen Welch, London Regional Cancer Program, (519) 685-8640	Open to Accrual
I240	An Immunotherapy Platform Study in Platinum Resistant High Grade Serous Ovarian Cancer (IPROC) The purpose of the pre-study screening is to test for biomarkers. This testing will be done on a sample of tissue removed from a previous surgery or biopsy. If a previous tissue sample is not available, a fresh tissue biopsy is required. Each substudy will be looking at what effects a new drug or drugs has on patients and their ovarian cancer and as well as side effects of treatment. The purpose of each substudy is to see if the biomarkers that were identified the screening sample can help predict which patients are most likely to be helped by that drug or drugs and to see how the cancer cells respond to treatment. Read More Complexity Level: 1 Eligibility: Patients (>=18 yrs old, ECOG PS 0-1), life expectancy >= 3 mo., must have platinum resistant high-grade serous carcinoma of ovarian, fallopian tube or peritoneal origin defined as progression within the last 6 mo. of last platinum containing chemo. Histological confirmation of original primary tumour. Measurable disease per RECIST 1.1. No limit on prior regimens for platinum sensitive disease but may not have received more than 1 cytotoxic chemotherapy regimen for platinum-resistant disease. Prior treatment with immune checkpoint inhibitors is allowed provided it was not discontinued due to severe/recurrent severe toxicity. May have received non-cytotoxic therapies excluding the agents targeted by the planned substudy. Consent to pre/on treatment tumour biopsies. No uncontrolled/serious illnesses or medical conditions which would not permit the patient to be managed per protocol. No central nervous system metastases. No prior autoimmune or inflammatory disorders within the past 3 yrs. Objectives: Primary: identify based on objective response rate (ORR) (complete and partial response) using RECIST 1.1, promising immunotherapy combinations for the treatment of high grade serious ovarian cancer for later validation in clinical trials. Secondary: evaluate ORR using iRECIST, determine progression free survival and overall survival of immunotherapy regimens (RECIST 1.1 and iRECIST), examine safety and tolerability of each regimen. Tertiary: explore utility of CA125 as a surrogate of response in patients receiving immunotherapies, identify potential predictive biomarkers/markers of response, generate biomarker and clinical data to identify new immunotherapy strategies/combinations for subsequent evaluation. NCT Registration ID (from clinicaltrials.gov): NCT04918186 Participation: Limited to invited centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: CCTG Led Trial Status: Open to Accrual Activation Date: October 12, 2021 Chair: (Canada) Dr. Helen MacKay, Odette Cancer Centre, (416) 480-5145	Open to Accrual
I240A	A Phase II Study of Durvalumab and BA3011, A CAB-AXL-ADCin Patients with Platinum Resistant High Grade Serous Ovarian Cancer The purpose of this study is to test the safety of the new drugs, durvalumab and BA3011, to see what effects they have on you and your cancer. This study will also look at the side effects of these two drugs. The researchers are also looking for ways to help predict who is most likely to be helped by these drugs by testing for other gene changes in tumour and blood samples. Read More Complexity Level: 1 Eligibility: Females of childbearing/reproductive potential must agree to use effective contraception on study and 6 months after last dose of BA3011. AXL-positive tumour in Stage 1. No prior therapy with agents targeting AXL or with a conjugated or unconjugated auristatin derivative / vinca targeting payload. No prior receipt of G-CSF or granulocyte/macrophage colony stimulating factor support 2 week prior to first BA3011 dose. No history of greater than or equal to 3 Grade allergic reactions to monoclonal antibody therapy or known/suspected allergy/ intolerance to any agent given during study. No serious medical conditions i.e; intracerebral arteriovenous malformation, cerebral aneurysm or stroke, history of hepatic encephalopathy; clinically significant ascites, measured by physical examination; active drug or alcohol abuse. Patients must not be using moderate or strong CYP3A inducers or inhibitors, including cannabidiol P-glycoprotein (P-gp) inhibitors or immunosupressants. Participation: Limited to invited centres NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: CCTG Led Trial Status: Open to Accrual Activation Date: October 12, 2021 Chair: (Canada) Dr. Anna Tinker, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2707	Open to Accrual
I240B	A Phase II Study of Durvalumab and BA3021, A CAB-ROR2-ADC in Patients with Platinum Resistant High Grade Serous Ovarian Cancer The purpose of this study is to test the safety of the new drugs, durvalumab and BA3021, to see what effects they have on you and your cancer. This study will also look at the side effects of these two drugs. The researchers are also looking for ways to help predict who is most likely to be helped by these drugs by testing for other gene changes in tumour and blood samples. Read More Complexity Level: 1 Eligibility: Females of childbearing/reproductive potential must agree to use effective contraception while on the study and for 6 months after last dose of BA3021. ROR2-postive tumour in Stage 2. No prior therapy with agents targeting ROR2, or with a conjugated or unconjugated auristatin derivative / vinca targeting payload. No prior receipt of G-CSF or granulocyte/macrophage colony stimulating factor support 2 week prior to first BA3021 dose. No history of ? 3 Grade allergic reactions to monoclonal antibody therapy or known/suspected allergy/ intolerance to any agent given during study. No serious medical conditions i.e; intracerebral arteriovenous malformation, cerebral aneurysm or stroke, history of hepatic encephalopathy; clinically significant ascites, as measured by physical examination; active drug or alcohol abuse. No use of moderate or strong CYP3A inducers or inhibitors, including cannabidiol P-glycoprotein (P-gp) inhibitors or immunosupressants. Objectives: See main protocol Participation: Limited to invited centres NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: CCTG Led Trial Status: Open to Accrual Activation Date: October 12, 2021 Chair: (Canada) Dr. Anna Tinker, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2707	Open to Accrual
CX5 (CX5)	A Randomized Phase III Trial Comparing Radical Hysterectomy and Pelvic Node Dissection vs Simple Hysterectomy and Pelvic Node Dissection in Patients with Low-Risk Early Stage Cervical Cancer. (SHAPE) Read More Complexity Level: 1 Eligibility: Histologically confirmed adenocarcinoma, squamous, or adenosquamous cancer of the cervix. Diagnosis has been made by LEEP, cone or cervical biopsy and has been reviewed and confirmed by the local reference gynecological pathologist. Objectives: Evaluate whether treatment with radical hysterectomy and pelvic node dissection is non-inferior to treatment with simple hysterectomy and pelvic node dissection in terms of pelvic-relapse free survival. Compare the rates of treatment-related toxicity, extrapelvic relapse-free survival, and overall survival. Compare rates of sentinel node detection, and rates of parametrial, margins and pelvic nodes involvement Compare quality of life (including sexual health) NCT Registration ID (from clinicaltrials.gov): NCT01658930 Participation: Open to member centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Closed to Accrual Activation Date: August 02, 2012 Closing Date: November 29, 2019 Chair: (UK) Prof. John Tidy, National Cancer Research Institute (NCRI), (France) Dr. Gwenael Ferron, Grp D'Investigater Nationaux, () Dr. Patrick Maguire, (The Netherlands) Dr. Cor de Kroon, The Dutch Gynecological Oncology Group (DGOG), (61) 540-8037, (Austria) Dr. Christian Marth, Medical University, (512) 504-23050, (South Korea) Dr. Jae-weon Kim, Korean Gynecology Oncology Group (KGOG), (Belgium) Dr. Frederic Goffin, Belgian Gynaecological Oncology Group (BGOG), (Canada) Dr. Marie Plante, CHUQ - Hotel-Dieu de Quebec, (418) 691-5392	Closed to Accrual
CXC2 (NRG GY006)	A Randomized Phase III Trial of Radiation Therapy and Cisplatin Alone or in Combination with Intravenous Triapine in Women with Newly Diagnosed Bulky Stage IB2, Stage II, IIIB, or IVA Cancer of the Uterine Cervix or Stage II-IVA Vaginal Cancer Read More Complexity Level: 2 Eligibility: Patient has a new, untreated histologic diagnosis of stage IB2 (> 4 cm), II, IIIB or IVA squamous, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix (FIGO 2009) or stage II-IVA squamous, adenocarcinoma, or adenosquamous carcinoma of the vagina not amenable to curative surgical resection alone. The presence or absence of para-aortic lymph node metastasis will be based on pre-therapy (18)F FDG PET/CT. NOTE: If the baseline (18)F FDG PET/CT identifies hypermetabolic para-aortic disease, such patients will NOT be eligible. The patient must be able to tolerate imaging requirements of an (18)F FDG PET/CT scan. Objectives: Primary Objective:To evaluate the efficacy of the experimental regimen of triapine (3AP), cisplatin, and radiation to increase overall survival relative to the standard / control regimen of cisplatin and radiation in women with uterine cervix or vaginal cancer. Secondary Objective: To determine the relative progression-free survival impact of triapine-cisplatin radio-chemotherapy and cisplatin radio-chemotherapy. NCT Registration ID (from clinicaltrials.gov): NCT02466971 Participation: Open to member centres NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Closed to Accrual Activation Date: April 30, 2021 Closing Date: September 22, 2022 Chair: (Canada) Dr. Eric Leung, Odette Cancer Centre, (416) 480-5000 Ext. 6165	Closed to Accrual
EN7 (DCGOG PORTEC-3)	Randomized Phase III Trial Comparing Concurrent Chemoradiation and Adjuvant Chemotherapy with Pelvic Radiation Alone in High Risk and Advanced Stage Endometrial Carcinoma. Read More Complexity Level: 2 Eligibility: Histologically confirmed endometrial carcinoma, grade of differentiation determined according to the FIGO/AFIP criteria, with one of the following postoperative FIGO 2009 stages; confirmed at pathology review: Stage IA with myometrial invasion, grade 3 with documented lymph-vascular space invasion (LVSI); Stage IB grade 3; Stage II; Stage IIIA or IIIC; or IIIB if parametrial invasion; Stage IA with myometrial invasion, IB, II or IIIA/C with serous or clear cell histology. Objectives: Overall and failure free survival; toxicity; Quality of Life; Pelvic and distant recurrence; Translational studies on paraffin fixed tissue. NCT Registration ID (from clinicaltrials.gov): NCT00411138 Participation: Open to member centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Closed to Accrual Activation Date: September 03, 2008 Closing Date: December 20, 2013 Chair: (The Netherlands) Dr. Carien L. Creutzberg, The Dutch Gynecological Oncology Group (DGOG), (71) 526-3052, (Canada) Dr. Paul Bessette, Centre hospitalier universitaire de Sherbrooke, (819) 346-1110 Ext. 13120, (Canada) Dr. Anthony Fyles, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-6522	Closed to Accrual
ENC1 (NRG GY018)	A Phase III Randomized, Placebo-Controlled Study of Pembrolizumab (MK-3475, NSC#776864) in Addition to Paclitaxel and Carboplatin for Measurable Stage III or IVA, Stage IVB or Recurrent Endometrial Cancer Read More Complexity Level: 2 Eligibility: women with measurable stage III, measurable stage IVA, stage IVB (with or without measurable disease) or recurrent (with or without measurable disease) endometrial cancer. Objectives: Primary Objective: To evaluate the efficacy of pembrolizumab in combination with paclitaxel and carboplatin in patients with advanced stage (measurable stage III or IVA), stage IVB and recurrent endometrial cancer. Efficacy will be determined via investigator assessed progression free survival (PFS) in two distinct populations referred to as proficient and deficient mismatch repair (pMMR and dMMR). NCT Registration ID (from clinicaltrials.gov): NCT03914612 Participation: Open to member centres NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Closed to Accrual Activation Date: October 29, 2019 Closing Date: December 06, 2022 Chair: (Canada) Dr. Stephen Welch, London Regional Cancer Program, (519) 685-8640	Closed to Accrual
OV25	A Randomized Phase II Double-Blind Placebo-Controlled Trial of Acetylsalicylic Acid (ASA) in Prevention of Ovarian Cancer in Women with BRCA 1/2 Mutations (STICs and STONEs) Read More Complexity Level: 2 Eligibility: Women with documented germline BRCA 1/2 mutations, scheduled to undergo risk-reducing surgery (bilateral salpingo-oophorectomy or bilateral salpingectomy inclusive of fimbria) within 6 months to 2 years after the date of randomization. Objectives: PRIMARY OBJECTIVE: To compare the frequency of pre- & early-malignant lesions (serous tubal intraepithelial carcinomas (STICs) or serous tubal occult neoplasias - early (STONEs) in the fallopian tube, at the time of risk reducing surgery. SECONDARY OBJECTIVE: To assess subject acceptance of ASA intervention in a female cohort at high risk for ovarian cancer. TERTIARY OBJECTIVES: (1) To characterize the effect of ASA on high grade serous ovarian cancer (HGSOC) tumourigenesis and to examine the linkage between tumourigenesis and microenvironment. (2) Biobanking for future correlative studies NCT Registration ID (from clinicaltrials.gov): NCT03480776 Participation: Open to member centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: CCTG Led Trial Status: Closed to Accrual Activation Date: April 06, 2018 Closing Date: December 15, 2022 Chair: (Canada) Dr. Stephanie Lheureux, University Health Network, (416) 946-4501 Ext. 2415, (Canada) Dr. Amit M. Oza, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-2818	Closed to Accrual
OV26 (CRUK/UCL ICON9)	An International Phase III Randomised Study to Evaluate the Efficacy of Maintenance Therapy with Olaparib and Cediranib or Olaparib Alone in Patients with Relapsed Platinum-sensitive Ovarian Cancer Following a Response to Platinum-Based Chemotherapy Read More Complexity Level: 2 Eligibility: Histologically proven diagnosis of high grade serous or endometrioid carcinoma of the ovary, fallopian tube or peritoneum, progressing more than 6 months after day 1 of the last cycle of first-line platinum-based chemotherapy and requiring treatment with second-line platinum-based chemotherapy. CT or MRI proven relapsed disease at first recurrence (measurable or non-measurable) prior to starting second-line treatment or surgically debulking. Completed a minimum of 4 cycles of platinum-based chemotherapy for first relapse (2nd line treatment) Objectives: I. Progression free survival (PFS) measured from the date of randomisation to the date of objective progression (investigator assessed using RECIST v1.1) or date of death from any cause (in the absence of progression) II. Overall survival measured from the date of randomisation to the date of death from any cause I. Toxicity II. Adherence to maintenance therapy- compliance and dose reductions and interruptions III. PFS and OS measured from the start of second-line chemotherapy IV. TSST (the time from randomisation to start of second subsequent treatment or death) V. Quality of Life using EORTC QLQC30 and OV28 VI. Cost effectiveness using EQ-5D-5L for economic evaluation VII. Progression free survival by CA125 - GCIG criteria VIII. Response rate (RECIST v1.1 and/or CA125) at 16 weeks of treatment in patients who had RECIST v1.1 measurable disease or elevated CA125 at randomisation. RECIST measurements will be based on investigator assessment not central review NCT Registration ID (from clinicaltrials.gov): NCT03278717 Participation: Open to member centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Closed to Accrual Activation Date: November 26, 2020 Closing Date: May 24, 2023 Chair: (Canada) Dr. Helen MacKay, Odette Cancer Centre, (416) 480-5145	Closed to Accrual
OVC1 (NRG GY004)	A Phase III Study Comparing Single-agent Olaparib or the Combination of Cediranib and Olaparib to Standard Platinum-based Chemotherapy in Women with Recurrent Platinum-sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Read More Complexity Level: 2 Eligibility: women with recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer Objectives: Primary Objective: Assess the efficacy of either single agent olaparib or the combination of cediranib and olaparib, as measured by PFS, as compared to standard platinum-based chemotherapy in the setting of recurrent platinum-sensitive ovarian, primary peritoneal or fallopian tube cancer. Secondary Objectives:Assess the efficacy of single agent olaparib or the combination of cediranib and olaparib, as measured by response rate, and overall survival as compared to standard platinum-based chemotherapy in the setting of recurrent platinum-sensitive ovarian, primary peritoneal or fallopian tube cancer. NCT Registration ID (from clinicaltrials.gov): NCT02446600 Participation: Open to member centres NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Closed to Accrual Activation Date: January 04, 2017 Closing Date: November 10, 2017 Chair: (Canada) Dr. Helen MacKay, Odette Cancer Centre, (416) 480-5145	Closed to Accrual
OVC2 (NRG GY005)	A Randomized Phase II/III study of the Combination of Cediranib and Olaparib Compared to Cediranib or Olaparib Alone, or Standard of Care Chemotherapy in Women with Recurrent Platinum-resistant or -Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (COCOS) Read More Complexity Level: 2 Eligibility: women with recurrent platinum-resistant or -refractory ovarian, fallopian tube, or primary peritoneal cancer Objectives: Primary Objective: To assess the efficacy and identify (in)active arm(s) of the combination of cediranib and olaparib, cediranib alone, olaparib alone, and physician's choice standard of care chemotherapy, as measured by PFS in the setting of recurrent platinum-resistant or-refractory ovarian, primary peritoneal or fallopian tube cancer. Secondary Objectives: - To assess the efficacy of the combination of cediranib and olaparib, cediranib alone, olaparib alone, and physician's choice standard of care chemotherapy, as measured by objective response rate (ORR: partial or complete response) by RECIST criteria, in the setting of recurrent platinum-resistant or-refractory ovarian, primary peritoneal or fallopian tube cancer. - To assess safety endpoints, as measured by frequency and severity of adverse events by Common Terminology Criteria for Adverse Events NCT Registration ID (from clinicaltrials.gov): NCT02502266 Participation: Open to member centres NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Closed to Accrual Activation Date: January 19, 2017 Closing Date: October 02, 2020 Chair: (Canada) Dr. Diane Provencher, CHUM-Centre Hospitalier de l'Universite de Montreal, (514) 890-8444	Closed to Accrual
CX1	A Phase II Study to Evaluate the Toxicity and Efficacy of Concurrent Cisplatin and Radiation Therapy in the Treatment of Patients with Locally Advanced Squamous Cell Carcinoma of the Cervix Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: May 01, 1990 Closing Date: April 12, 1991	Permanently Closed
CX2	A Phase III Study Comparing Concurrent Cisplatin and Radiation Therapy versus Radiation Alone for Locally Advanced Squamous Cell Carcinoma of the Cervix Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: April 12, 1991 Closing Date: September 30, 1996	Permanently Closed
CX3	A Phase III Randomized Study of Cisplatin Alone versus a Combination of Etoposide, Ifosfamide and Cisplatin (VIP) in the Treatment of Persistent, Recurrent or Advanced Squamous or Adenosquamous Cell Carcinoma of the Cervix Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: October 16, 1992 Closing Date: November 19, 1993	Permanently Closed
CX4 (0191)	Phase III trial to Evaluate the Efficacy of Maintaining Hemoglobin Levels Above 120 g/L with Erythropoietin Versus Above 100 g/L without Erythropoietin in Anemic Patients Receiving Concurrent Radiation and Cisplatin for Cervical Cancer Read More Complexity Level: 2 Eligibility: Patients with primary, previously untreated, histologically confirmed invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix, Stage II-B, III-B, IV-A. Objectives: To assess the efficacy of raising and maintaining patient hemoglobin level above 120 g/L using erythropoietin compared to maintenance level above 100 g/L without erythropoietin on progression-free survival, overall survival and local control in anemic patients with carcinoma of the cervix receiving concurrent radiation and cisplatin treatment. NCT Registration ID (from clinicaltrials.gov): NCT00017004 Participation: Open to member centres NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Permanently Closed Activation Date: October 19, 2001 Closing Date: January 17, 2004	Permanently Closed
CXC1 (0219)	A Phase III, Randomized Trial of Weekly Cisplatin and Radiation versus Cisplatin and Tirapazamine and Radiation in Stage 1B2, IIA, IIB, IIIB and IVA Cervical Carcinoma Limited to the Pelvis. Read More Complexity Level: 2 Eligibility: Patients with histologically confirmed invasive squamous cell, adenocarcinoma, or adenosquamous carcinoma of the cervix stages IB2, IIA, IIB, IIIB or IVA. Objectives: To determine if combining TPZ with cisplatin during radiation therapy increases recurrence-free survival(RFS) when compared with weekly cisplatin and radiation therapy in this patient population. NCT Registration ID (from clinicaltrials.gov): NCT00262821 Participation: Open to member centres NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Permanently Closed Activation Date: July 20, 2006 Closing Date: September 01, 2009	Permanently Closed
EN1	Chemotherapy of Stage IV Metastatic and Recurrent Carcinoma of the Uterine Corpus Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: July 06, 1975 Closing Date: November 11, 1980	Permanently Closed
EN4 (55874)	Intergroup (EORTC, NCIC CTG) Phase III Study to Evaluate the Role of Adjuvant Radiotherapy in the Treatment of Uterine Sarcomas Stages I and II Read More NCT Registration ID (from clinicaltrials.gov): NCT00002459 NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: Intergroup Led Trial Status: Permanently Closed Activation Date: June 26, 1995 Closing Date: August 10, 2001	Permanently Closed
EN5	A Phase III Randomized Trial Comparing TAH BSO versus TAH BSO Plus Adjuvant Pelvic Irradiation in Intermediate Risk, Carcinoma of the Endometrium Read More Eligibility: Patients with histologically confirmed adenocarcinoma of the endometrium (Stage IA [grade 3] or IB [grade 3] or IC [grade 1 or 2 or 3]) or stage IIA treated by total abdominal hysterectomy with bilateral salpingo-oophorectomy who have not received prior pelvic radiotherapy. Patients may receive first-line brachytherapy (if local standard). Objectives: In collaboration with the MRC UK ASTEC trial analysis, to compare overall survival; to evaluate the differences in recurrence-free survival, duration of pelvic control and toxicity and tolerability. Canadian components to analyse quality of life and sexual health. NCT Registration ID (from clinicaltrials.gov): NCT00002807 Participation: Not limited NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: July 04, 1996 Closing Date: March 31, 2005	Permanently Closed
GT1 (0174)	A Randomized Phase III Trial of Weekly Parenteral Methotrexate Versus "Pulsed" Dactinomycin for Primary Management of Low Risk Gestational Trophoblastic Neoplasia Read More Eligibility: Patients with untreated, histologically confirmed low risk GTN (persistent hydatidform mole or choriocarcinoma). Patients must have a pretreatment WHO score of 0 - 6 and a GOG performance status of 0 - 2. Objectives: To determine whether weekly parenteral methotrexate or "pulsed" dactinomycin is the more effective treatment for low risk gestational trophoblastic neoplasia. To prospectively determine and compare the toxicity of each regimen. To prospectively determine whether the definition of persistent GTN is accurate. NCT Registration ID (from clinicaltrials.gov): NCT00003702 Participation: Open to member centres NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: Intergroup Led Trial Status: Permanently Closed Activation Date: October 18, 2000 Closing Date: February 26, 2007	Permanently Closed
I102	NCIC CTG Phase II Study of BMS-182751 (JM-216) in Patients With Advanced and/or Recurrent Squamous Cell Carcinoma of the Cervix Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: January 27, 1997 Closing Date: February 16, 1999	Permanently Closed
I106	NCIC CTG Phase II Study of Topotecan/Cisplatin/Paclitaxel as First-Line Chemotherapy for Patients With Advanced Ovarian Cancer Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: June 10, 1997 Closing Date: May 07, 1998	Permanently Closed
I106B	Phase II Study of Topotecan/Cisplatin Followed by Paclitaxel/Carboplatin as First-Line Chemotherapy for Patients With Advanced Ovarian Cancer Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: April 27, 1999 Closing Date: December 16, 1999	Permanently Closed
I116	NCIC CTG Phase II Study of CGP 69846A (ISIS 5132) in Recurrent Epithelial Ovarian Cancer Read More NCT Registration ID (from clinicaltrials.gov): NCT00003892 NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: February 01, 1999 Closing Date: May 05, 2000	Permanently Closed
I12	NCIC CTG Phase II Study of CBDCA in Ovary Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: August 01, 1984 Closing Date: February 21, 1985	Permanently Closed
I126	A Phase II Study of Letrozole in Patients With Advanced or Recurrent Endometrial Cancer Read More NCT Registration ID (from clinicaltrials.gov): NCT00004251 NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: January 19, 2000 Closing Date: May 16, 2001	Permanently Closed
I138	NCIC CTG Randomized Phase II Study of NX211 Given by Two Different Intravenous Schedules in Advanced and/or Recurrent Epithelial Ovarian Cancer Read More Eligibility: Histologically documented advanced and/or recurrent epithelial ovarian cancer (primary fallopian or peritoneal cancer also eligible). One or two prior regimens of chemotherapy required with at least one regimen containing cisplatin or carboplatin. At least one site unidimensional disease. Objectives: To evaluate, in parallel, the efficacy of two treatment schedules of NX211 as determined by objective response and tumour marker (CA125) in patients with advanced and/or recurrent ovarian cancer. To evaluate the safety, time to progression, and pharmacokinetics of both treatment schedules. NCT Registration ID (from clinicaltrials.gov): NCT00010179 NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: October 31, 2000 Closing Date: September 21, 2001	Permanently Closed
I148	A Phase II Study of OSI-774 (NSC 718781) in Patients With Locally Advanced and/or Metastatic Carcinoma of the Endometrium Read More Eligibility: Patients with histologically documented endometrial cancer. Clinically and/or radiologically documented disease. Unidimensionally measurable disease. Tumour tissue available from primary tumour to assess EGFR status. Patients may have had up to one prior hormonal treatment (adjuvant or metastatic). No prior chemotherapy permitted. No prior EGFR targeting therapy permitted. Objectives: To assess the efficacy (response rate and duration of stable disease) of OSI-774 given daily to patients with advanced/metastatic carcinoma of the endometrium. To assess toxicity, time to progression and response duration of OSI-774 in this patient population. To correlate objective tumour response with EGFR expression from primary tumour in these patients. To explore patterns of change in markers of EGFR activation in patients that have biopsies (additional investigations). NCT Registration ID (from clinicaltrials.gov): NCT00030485 NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: January 10, 2002 Closing Date: March 16, 2004	Permanently Closed
I149	A Phase II Study Of OSI-774 (NSC 718781) Given In Combination With Carboplatin In Patients With Recurrent Epithelial Ovarian Cancer Read More Eligibility: Patients with histologically documented epithelial ovarian cancer. Clinically and/or radiologically documented disease. Unidimensionally measurable disease. Tumour tissue available from primary tumour to assess EGFR status. Up to 2 prior chemotherapy regimens with the first regimen containing carboplatin or cisplatin. Patients MUST have responded to platinum based first-line chemotherapy. No prior EGFR targeting therapy permitted. Objectives: To assess the efficacy (response rate and duration of stable disease) of OSI-774 given daily to patients with advanced ovarian carcinoma who are reveiving carboplatin. To assess toxicity, time to progression and response duration of OSI-774 in this patient population. To correlate objective tumour response with EGFR status from primary tumour in these patients. To explore patterns of change in EGFR markers in patients that have biopsies and/or ascitic taps (additional investigations). To assess CA 125 response in patients with elevated CA 125 levels at study entry. NCT Registration ID (from clinicaltrials.gov): NCT00030446 NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: January 10, 2002 Closing Date: June 01, 2004	Permanently Closed
I160	A Phase II Study Of CCI-779 In Patients With Metastatic and/or Locally Advanced Recurrent Endometrial Cancer Read More Complexity Level: 2 Eligibility: Patients with histologically documented endometrial cancer. Clinically and/or radiologically documented disease. Unidimensionally measurable disease. Tumour tissue available from primary tumour to assess molecular markers of CCI-779 activation. Group A patients may have had up to one prior hormonal treatment (adjuvant or metastatic) with no prior chemotherapy permitted. Group B patients may have had an unlimited number of prior hormonal treatments (adjuvant or metastatic) and must have had one cycle of cytotoxic chemotherapy. Objectives: To assess the efficacy (response rate and duration of stable disease) of CCI-779 given IV weekly in patients with metastatic and/or locally advanced recurrent carcinoma of the endometrium. To assess the adverse events, time to progression and response duration of CCI-779 given IV weekly in patients with metastatic and/or locally advanced recurrent carcinoma of the endometrium. To correlate objective tumour response with PTEN expression in the tumour tissue obtained at diagnosis (primary tumour). To explore the relatinoship between objective tumour response with other molecular measures in diagnostic tumour tissue. NCT Registration ID (from clinicaltrials.gov): NCT00072176 Participation: Limited to invited centres only. NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: January 14, 2004 Closing Date: June 15, 2007	Permanently Closed
I184	A Phase II Study of Sunitinib, an Oral Multi-Targeted Tyrosine Kinase Inhibitor, in Patients with Unresectable, Locally Advanced or Metastatic Cervical Carcinoma Read More Eligibility: Patients with histological/cytological documented squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma of the cervix (advanced, recurrent or persistent disease). Maximum of 1 prior chemotherapy regimen for metastatic disease. Prior neoadjuvant, adjuvant or concurrent chemoradiartion is permitted. Objectives: To assess the efficacy (objective response rate) of sunitinib given orally daily for 4 out of every 6 weeks in patients with unresectable, locally advanced or metastatic carcinoma of the cervix. To assess the toxicity of sunitinib in patients with unresectable, locally advanced or metastatic carcinoma of the cervix. To document time to progression, early objective progression rate, and, if objective responses are observed, response duration. NCT Registration ID (from clinicaltrials.gov): NCT00389974 Participation: Limited to invited centres NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: November 09, 2006 Closing Date: May 12, 2008	Permanently Closed
I185	A Phase II Study Of Sunitinib (SU11248; NSC 736511) In Patients With Recurrent Epithelial Ovarian, Fallopian Tube Or Primary Peritoneal Carcinoma Read More Eligibility: Patients with histological documented epithelial ovarian, fallopian tube carcinoma or primary peritoneal cancer (advanced or metastatic disease). Minimum of 1 and maximum of 2 prior chemotherapy regimens, one of which must be platinum containing. Objectives: To assess the efficacy (response rate) of sunitinib given orally daily for 4 out of every 6 weeks in patients with advanced or metastatic previously treated epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. To assess the toxicity of sunitinib in patients with advanced or metastatic previously treated epithelial ovarian, fallopian tube or primary peritoneal carcinoma. To document CA125 response rate, early objective progression rate, and, if objective responses are observed, response duration. NCT Registration ID (from clinicaltrials.gov): NCT00388037 Participation: Limited to invited centres NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: November 10, 2006 Closing Date: April 17, 2008	Permanently Closed
I192	A Phase II Study of Ridaforolimus in Patients with Metastatic and/or Locally Advanced Recurrent Endometrial Cancer Read More Complexity Level: 2 Eligibility: Patients with histologically documented endometrial cancer. Clinically and/or radiologically documented disease. Unidimensionally measurable disease. Tumour tissue available from primary tumour to assess molecular markers of deforolimus activation. Prior hormonal treatment (adjuvant or metastatic), but no prior chemotherapy permitted. Objectives: To assess the efficacy (response rate and duration of stable disease) of ridaforolimus given orally, once daily, 5 days/week continuously in patients with metastatic and/or locally advanced recurrent carcinoma of the endometrium. To assess the adverse events, time to progression and response duration of ridaforolimus in patients with metastatic and/or locally advanced recurrent carcinoma of the endometrium. To correlate objective tumour response with PTEN expression in the tumour tissue obtained at diagnosis (primary tumour). NCT Registration ID (from clinicaltrials.gov): NCT00770185 Participation: Limited to invited centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: August 26, 2008 Closing Date: August 11, 2010	Permanently Closed
I199	A Phase II Study of Temsirolimus (NSC 683864), an mTOR Inhibitor, in Patients with Recurrent, Unresectable, Locally Advanced or Metastatic Carcinoma of the Cervix. Read More Complexity Level: 2 Eligibility: Patients with histologically or cytologically confirmed squamous cell carcinoma or adenosquamous carcinoma of the cervix, or adenocarcinoma of the cervix. Clinically and/or radiologically documented disease. Only one prior chemotherapy regimen allowed. Patient must be > 4 weeks since chemotherapy, radiation therapy and surgery. No prior treatment with an mTOR inhibitor. Patient must have tumour tissue from their primary tumour available. Objectives: 1.1 To assess the efficacy (objective response rate) of temsirolimus given IV weekly in patients with metastatic and/or locally advanced recurrent carcinoma of the cervix. 1.2 To assess the adverse events, time to progression and response duration of temsirolimus given IV weekly in patients with metastatic and/or locally advanced recurrent carcinoma of the cervix. 1.3 To explore the relationship between expression of proteins in the mTOR pathway in archival tissue samples from patients on this trial and their objective response to therapy. NCT Registration ID (from clinicaltrials.gov): NCT01026792 Participation: Limited to invited centres NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: December 17, 2009 Closing Date: October 27, 2011	Permanently Closed
I25	NCIC CTG Phase II Study of Trimetrexate in Ovary Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: July 28, 1986 Closing Date: May 02, 1988	Permanently Closed
I51	NCIC CTG Phase I Study of GM-CSF + Carboplatin/Cyclophosphamide in Ovary Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: May 29, 1989 Closing Date: February 10, 1990	Permanently Closed
I51A	NCIC CTG Phase I Study of GM-CSF Plus Carboplatin in Ovary Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: February 10, 1990 Closing Date: September 28, 1990	Permanently Closed
I59	NCIC CTG Phase I Study of IL-3 in Patients With Relapsed Ovarian Cancer Receiving Carboplatin Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: December 10, 1990 Closing Date: March 27, 1992	Permanently Closed
I74	NCIC CTG Phase I Study of Biweekly Taxol/Cisplatin as Initial Chemotherapy for Ovarian Cancer Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: November 02, 1992 Closing Date: October 07, 1994	Permanently Closed
I82	NCIC CTG Randomized Phase II Study of Topotecan in Previously Treated Patients With Ovarian Cancer Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: July 08, 1994 Closing Date: April 22, 1997	Permanently Closed
OV1	Treatment of Patients With Advanced Ovarian Carcinoma (Stages III and IV) With Melphalan, 5 Fluorouracil and Methotrexate in Combination and Sequentially Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: April 04, 1974 Closing Date: March 07, 1977	Permanently Closed
OV10 (55931)	Intergroup Phase III Comparison of a Combination of TAXOL-Platinum and a Combination of Cyclophosphamide-Platinum Chemotherapy in the Treatment of Advanced Epithelial Ovarian Cancer. Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: Intergroup Led Trial Status: Permanently Closed Activation Date: June 03, 1994 Closing Date: July 31, 1995	Permanently Closed
OV11 (9619)	A Phase II Trial of Intraperitoneal Cisplatin and Intravenous and Intraperitoneal Paclitaxel in Women with Optimally-Debulked Stage III Epithelial Ovarian Cancer Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: Intergroup Led Trial Status: Permanently Closed Activation Date: June 21, 1996 Closing Date: May 15, 1998	Permanently Closed
OV12	A Phase III Comparison of BAY 12-9566 versus Placebo as Consolidation After Standard Chemotherapy in Patients with Epithelial Ovarian Cancer Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: May 06, 1998 Closing Date: September 20, 1999	Permanently Closed
OV13 (EORTC 55971)	An International Multi-Centre Randomized Phase III Study Comparing Upfront Debulking Surgery Versus Neo-Adjuvant Chemotherapy in Patients With Stage IIIC or IV Epithelial Ovarian Carcinoma Read More Complexity Level: 2 Eligibility: Patients with histologically confirmed stage IIIc or IV epithelial ovarian, peritoneal or fallopian tube carcinoma with a performance status of < 2 (WHO), adequate blood counts and liver and renal function. Objectives: To compare overall survival; to evaluate the differences in progression free survival, toxicity and tolerability and quality of life. NCT Registration ID (from clinicaltrials.gov): NCT00003636 Participation: Open to member centres NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: Intergroup Led Trial Status: Permanently Closed Activation Date: May 13, 1999 Closing Date: November 30, 2006	Permanently Closed
OV15 (OVAR 2.5)	International Randomized Phase III Study Comparing Gemcitabine Plus Carboplatin Versus Carboplatin Monotherapy in Patients with Advanced Epithelial Ovarian Carcinoma Who Failed First-Line Platinum-Based Therapy Read More Eligibility: Patients with histologically proven ovarian carcinoma with evidence of recurrence or progression, which is not amenable to curative surgery or radiotherapy. Patients must have failed first-line platinum-containing therapy more than 6 months after treatment discontinuation. Objectives: To compare the time to progressive disease (TTPD) in patients treated with gemcitabine plus carboplatin versus carboplatin monotherapy. The secondary objectives of this study are to compare the following in the two arms: response rate, duration of response, survival time, toxicity, and changes in quality of life over time. NCT Registration ID (from clinicaltrials.gov): NCT00006453 Participation: Open to member centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Permanently Closed Activation Date: October 17, 2000 Closing Date: April 15, 2002	Permanently Closed
OV16 (OV16)	A Phase III Study of Cisplatin Plus Topotecan Followed by Paciltaxel plus Carboplatin versus Paclitaxel plus Carboplatin as First Line Chemotherapy in Women with Newly Diagnosed Advanced Epithelial Ovarian Cancer Read More Complexity Level: 2 Eligibility: Patients with confirmed epithelial ovarian (or primary fallopian or peritoneal) cancer, Stage IIB to IV, with microscopic or macroscopic residual disease who have not received prior chemotherapy and have evidence of adequate organ function. Objectives: Primary: to compare progression free survival. Secondary: to compare overall survival, response rates, toxic effects, quality of life, and CA 125 normalization rates. NCT Registration ID (from clinicaltrials.gov): NCT00028743 Participation: Not limited NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: August 31, 2001 Closing Date: June 29, 2005	Permanently Closed
OV17 (CALYPSO)	A Multi-National, Randomized, Phase III, GCIG Intergroup Study Comparing Pegylated Liposomal Doxorubicin (Caelyx) and Carboplatin vs. Paclitaxel and Carboplatin in Patients with Epithelial Ovarian Cancer in Late Relapse (>6 months): GCIG Calypso Study Read More Complexity Level: 2 Eligibility: Epithelial cancer of the ovary in progression > 6 months (late relapse) after a first or a second line including a platinum-derivative. Patients should have received previously a taxane. Objectives: Primary objective: Progression-free survival (PFS) between both treatment groups Secondary objectives Overall survival (OS) Toxicities Quality of life (QOL) NCT Registration ID (from clinicaltrials.gov): NCT00189553 Participation: Open to member centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Permanently Closed Activation Date: October 17, 2005 Closing Date: September 25, 2007	Permanently Closed
OV19 (MRC ICON7)	A Randomized, Two-Arm, Multi-Center Gynecologic Cancer Intergroup Trial of Adding Bevacizumab To Standard Chemotherapy (Carboplatin And Paclitaxel) In Patients With Epithelial Ovarian Cancer. Read More Complexity Level: 2 Eligibility: ICON7 will include patients with newly diagnosed, histologically confirmed, high risk FIGO stage I and IIa (Grade 3 or clear cell carcinoma only) and FIGO stage IIb - IV (all grades and all histological types) epithelial ovarian, fallopian tube or primary peritoneal cancer, who have undergone initial surgery (either debulking cytoreductive surgery or a biopsy if the patient has FIGO stage IV disease) and who will not be considered for cytoreductive surgery prior to disease progression. Patients with measurable and non-measurable disease (see Appendix 10) are eligible. Objectives: Primary: Progression-free survival. Secondary: Overall survival, Response rate (rate and duration), Adverse events, Quality of Life, Health Economics and Translational Research. NCT Registration ID (from clinicaltrials.gov): NCT00483782 Participation: Open to member centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Permanently Closed Activation Date: March 19, 2007 Closing Date: February 13, 2009	Permanently Closed
OV2	A Clinical Trial of Radiotherapy and Chemotherapy With Melphalan Following Surgery for Patients With Limited (Stage I, II & IIIo) Carcinoma of the Ovary Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: May 20, 1975 Closing Date: March 31, 1984	Permanently Closed
OV21 (OV21)	A Phase II Study of Intraperitoneal (IP) Plus Intravenous (IV) Chemotherapy Versus IV Carboplatin Plus Paclitaxel in Patients With Epithelial Ovarian Cancer Optimally Debulked at Surgery Following Neoadjuvant Intravenous Chemotherapy. Read More Complexity Level: 1 Eligibility: Epithelial Ovarian Cancer Primary Peritoneal Carcinoma Fallopian Tube Carcinoma Objectives: 9 month progression rate following randomization Progression-Free Survival, Overall Survival, Toxic Effects, Quality of Life NCT Registration ID (from clinicaltrials.gov): NCT00993655 Participation: Open to member centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: September 11, 2009 Closing Date: May 27, 2015	Permanently Closed
OV3	Second Co-operative Clinical Trial on Treatment of Ovarian Carcinoma Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: March 16, 1978 Closing Date: May 14, 1979	Permanently Closed
OV4	Third Cooperative Clinical Trial on Treatment of Advanced Ovarian Carcinoma Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: December 08, 1980 Closing Date: March 31, 1984	Permanently Closed
OV5A	Pilot Study of Weekly Adriamycin and Cisplatinum With Co-Trimoxazole Coverage in Patients With Stage III And IV Ovarian Cancer Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: August 22, 1983 Closing Date: May 01, 1984	Permanently Closed
OV6	Non-Randomized Study to Determine the Efficacy of Surgery Alone in Patients With Stage IA Or IB Epithelial Ovarian Carcinoma When Extensive Surgical Staging Has Been Done to Confirm Limited Disease Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: September 10, 1984 Closing Date: March 18, 1988	Permanently Closed
OV7	Clinical Trial Comparing Abdominal-Pelvic Radiation versus Cyclophosphamide and Cisplatin Chemotherapy in Patients With Epithelial Ovarian Carcinoma Having Only Microscopic Residual Disease Following Surgery Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: January 29, 1985 Closing Date: March 16, 1988	Permanently Closed
OV8	Clinical Trial Examining the Treatment of Patients With Macroscopic Residual Epithelial Ovarian Carcinoma. Part I - The Comparison of Cyclophosphamide and Cisplatin Versus Cyclophosphamide and Carboplatin as Initial Treatment Part II - The Comparison of Whole Abdominal Radiation versus Continuing Chemotherapy in Patients on Part I of the Study Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: June 07, 1985 Closing Date: March 17, 1989	Permanently Closed
OV8A	Pilot Study of Cyclophosphamide and Cisplatin in Patients With Ovarian Cancer Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: December 03, 1984 Closing Date: May 06, 1985	Permanently Closed
OV9	A Multicentre, Randomized Comparative Study of Taxol in Platinum Treated Ovarian Cancer (High vs. Low Dose; Long vs. Short Infusion) Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: August 06, 1991 Closing Date: March 06, 1992	Permanently Closed

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AL6

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ALC8

ALC9

BR37

BR38

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