Gynecologic Disease Site

Gynecologic

ID Sort	Study Title	Status Sort
I240C	A PHASE II STUDY OF TORIPALIMAB-TPZI (LOQTORZI ®) AND ENB-003, AN ENDOTHELIN B RECEPTOR (ETBR) INHIBITOR IN PATIENTS WITH PLATINUM RESISTANT OR REFRACTORY HIGH GRADE SEROUS OVARIAN CANCER OR CLEAR CELL OVARIAN CARCINOMA Complexity Level: 1 Eligibility: Patients must have platinum resistant or platinum refractory high grade serous or clear cell carcinoma of ovarian, fallopian tube or peritoneal origin. Platinum resistant disease defined as progression within 6 months of last platinum containing chemotherapy. Platinum refractory disease defined as progression during the administration of the first or second line of platinum containing chemotherapy. Histological confirmation of the original primary tumour. No limit to the number of prior regimens for platinum sensitive disease. But, patients may not have received more than one cytotoxic chemotherapy regimen for platinum resistant or refractory disease. If applicable, the use effective contraception defined as post-menopausal, surgically sterile (hysterectomy or ovariectomy) or on two forms of birth control while on study and 6 months after last treatment. of ENB-003 and toripalimab. Objectives: For complete list of objectives please refer to the main protocol. For this substudy imRECIST will be explored as a secondary objective. Participation: Open to member centres NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: CCTG Led Trial Status: Planned	Planned
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. 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
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. 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. 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. 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
VU2	STRatIfication of Vulvar squamous cell carcinoma by HPV and p53 status to guide Excision: STRIVE Study To estimate the 3-year local recurrence rates in participants with HPV-associated (HPV-A) and HPV-independent (HPV-I) vulvar squamous cell carcinoma (VSCC) where surgically management is based on dVIN/p53 status and tumour margin clearance. Complexity Level: 2 Eligibility: Histologically confirmed primary diagnosis of vulvar squamous cell carcinoma (VSSC). Surgically staged FIGO I-II VSCC. Vulvar resection according to standard of care guidelines. Post-operative margin assessment of tumour clearance, dVIN, and p53 status. Participants must be >/= 18 years old. Participants must enroll within 60 days of primary vulvar surgery. Local reference pathologist(s) review has been performed. Objectives: Primary: Estimate the 3-year local recurrence rates in participants with HPV-independent (HPV-I) and HPV-associated (HPV-A) VSCC surgically managed based on dVIN/p53 status and tumour margin clearance. Secondary: Estimate RFS, DSS and OS in both the HPV-I and HPV-A cohorts. Estimate health economic impact of surgical management based on molecular stratification and margin status in both cohorts. Describe PROs in both cohorts. Estimate recurrence rates of vulvar dVIN and/or p53abn (HPV-I cohort only). Exploratory: Identify prognostic or predictive molecular biomarkers in HPV-I and HPV-A VSCC. NCT Registration ID (from clinicaltrials.gov): NCT06358469 Participation: Open to member centres NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: CCTG Led Trial Status: Open to Accrual Activation Date: October 01, 2024 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	Open to Accrual
EN11 (RAINBO GREEN)	RAINBO: Refining Adjuvant treatment IN endometrial cancer Based On molecular features, TransPORTEC platform trials - The MMRD-GREEN trial Complexity Level: 2 Eligibility: Histologically confirmed diagnosis of EC of the following histologic subtypes: endometrioid endometrial carcinoma, serous endometrial carcinoma, uterine clear cell carcinoma, dedifferentiated and undifferentiated endometrial carcinoma, uterine carcinosarcoma, and mixed endometrial carcinomas of the aforementioned histotypes.Full molecular classification performed following the diagnostic algorithm described in WHO 2020. TLH-BSO or TAH-BSO with or without lymphadenectomy or sentinel node biopsy, without macroscopic residual disease after surgery. Molecular classification: MMRd EC (POLE status must be determined, and must be wildtype (or non-pathogenic) for inclusion.) Objectives: 2.1. Primary objective • 3-year RFS 2.2. Secondary objectives • RFS median and at 5 years • Vaginal RFS, pelvic RFS, distant metastasis free-survival (median, 3-year, 5-year) • Disease-specific survival (median, 3-year, 5-year) • OS (median, 3-year, 5-year) • HRQoL (EORTC QLQC30 and QLQEN24) • Safety & tolerability (NCI-CTC grade 3-5) • Explorative translational research , such as analysis PD-L1 positive subgroup (using SP263 assay (>1% and 5%). NCT Registration ID (from clinicaltrials.gov): NCT05255653-2 Participation: Open to member centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: On Hold Activation Date: July 07, 2023 Chair: (Canada) Dr. Stephen Welch, London Regional Cancer Program, (519) 685-8640	On Hold
CX6 (GINECO CE106)	International Validation Study of Sentinel Node Biopsy in Early Cervical Cancer SENTICOL III Complexity Level: 2 Eligibility: - With squamous or adenocarcinoma of the cervix (proven by biopsy or cone biopsy), - Stage Ia1 with lymphovascular emboli, Ia2, Ib1 IIa1, Ib2 (clinical stage) of the 2018 FIGO classification (see appendix 1), - Maximum diameter . 40 mm by clinical examination and/or magnetic resonance imaging (MRI), - No suspicious node on pelvic MRI with an exploration up to the left renal vein (according to RECIST 1.1), Objectives: - To assess that Disease Free Survival (DFS) is similar between pN0 patients after SLN biopsy versus SLN biopsy + PLN - To assess a superiority of SLN biopsy for quality of life (HR-QoL) NCT Registration ID (from clinicaltrials.gov): NCT03386734 Participation: Open to member centres NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: Intergroup Led Trial Status: Closed to Accrual Activation Date: July 24, 2020 Closing Date: May 27, 2024 Chair: (Canada) Dr. Vanessa Samouelian, CHUM-Centre Hospitalier de l'Universite de Montreal, (514) 890-8444	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 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
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 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) 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 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 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) 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
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) Complexity Level: 1 Eligibility: Histologically confirmed adenocarcinoma, squamous, or adenosquamous cancer of the cervix. Diagnosis has been made by LEEP, cone or cervical biopsy and has been reviewed and confirmed by the local reference gynecological pathologist. Objectives: Evaluate whether treatment with radical hysterectomy and pelvic node dissection is non-inferior to treatment with simple hysterectomy and pelvic node dissection in terms of pelvic-relapse free survival. Compare the rates of treatment-related toxicity, extrapelvic relapse-free survival, and overall survival. Compare rates of sentinel node detection, and rates of parametrial, margins and pelvic nodes involvement Compare quality of life (including sexual health) NCT Registration ID (from clinicaltrials.gov): NCT01658930 Participation: Open to member centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: August 02, 2012 Closing Date: November 29, 2019	Permanently Closed
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. Complexity Level: 2 Eligibility: Histologically confirmed endometrial carcinoma, grade of differentiation determined according to the FIGO/AFIP criteria, with one of the following postoperative FIGO 2009 stages; confirmed at pathology review: Stage IA with myometrial invasion, grade 3 with documented lymph-vascular space invasion (LVSI); Stage IB grade 3; Stage II; Stage IIIA or IIIC; or IIIB if parametrial invasion; Stage IA with myometrial invasion, IB, II or IIIA/C with serous or clear cell histology. Objectives: Overall and failure free survival; toxicity; Quality of Life; Pelvic and distant recurrence; Translational studies on paraffin fixed tissue. NCT Registration ID (from clinicaltrials.gov): NCT00411138 Participation: Open to member centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Permanently Closed Activation Date: September 03, 2008 Closing Date: December 20, 2013	Permanently Closed

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