Spots Global Cancer Trial Database for Refining Adjuvant Treatment IN Endometrial Cancer Based On Molecular Features
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Trial Identification
Brief Title: Refining Adjuvant Treatment IN Endometrial Cancer Based On Molecular Features
Official Title: Refining Adjuvant Treatment IN Endometrial Cancer Based On Molecular Features: the p53abn-RED Trial, the MMRd-GREEN Trial, the NSMP-ORANGE Trial and the POLEmut-BLUE Trial
Study ID: NCT05255653
Conditions
Study Description
Brief Summary: The RAINBO umbrella program consists of four clinical trials investigating new adjuvant therapies in endometrial cancer patients. Eligible patients will be assigned to one of the four RAINBO trials based on the molecular profile of their cancer: * p53 abnormal endometrial cancer patients to the p53abn-RED trial * mismatch repair deficient endometrial cancer patients to the MMRd-GREEN trial * no specific molecular profile endometrial cancer patients to NSMP-ORANGE trial * POLE mutant endometrial cancer patients to the POLEmut-BLUE trial
Detailed Description: The p53abn-RED trial (NCT05255653-1) is an international, multicenter, phase III randomised trial wherein adjuvant chemoradiation followed by olaparib for two years is compared to adjuvant chemoradiation. The MMRd-GREEN trial (NCT05255653-2) is an international, multicenter, phase III randomised trial wherein adjuvant pelvic external beam radiotherapy combined with and followed by durvalumab for one year is compared to adjuvant pelvic external beam radiotherapy. The NSMP-ORANGE trial (NCT05255653-3) is an international, multicenter, phase III randomised trial wherein adjuvant pelvic external beam radiotherapy followed by progestogens for two years is compared to adjuvant chemoradiation. The POLEmut-BLUE trial (NCT05255653-4) is an international, multicenter, single arm, phase II trial wherein safety of de-escalation of adjuvant therapy is investigated: no adjuvant therapy for stage I-II disease and no adjuvant therapy or pelvic external beam radiotherapy only for stage III disease. The overarching RAINBO research project will combine the data and tumor material of the four RAINBO clinical trials to perform translational research and compare molecular profile-based adjuvant therapy to standard adjuvant therapy in terms of effectiveness, toxicity, quality of life and cost utility.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
The POLEmut-BLUE trial: Princess Margaret Cancer Centre, University of Toronto, Toronto, , Canada
The POLEmut-BLUE trial: University of British Columbia, Vancouver, , Canada
The p53abn-RED trial: Institute Gustave Roussy, Villejuif, , France
Amsterdam University Medical Center, Amsterdam, , Netherlands
Amphia Ziekenhuis, Breda, , Netherlands
Instituut Verbeeten, Breda, , Netherlands
Haags Medisch Centrum, Den Haag, , Netherlands
Catharina Ziekenhuis, Eindhoven, , Netherlands
Medisch Spectrum Twente, Enschede, , Netherlands
Universitair Medisch Centrum Groningen, Groningen, , Netherlands
The MMRd-GREEN trial: Leiden University Medical Center, Leiden, , Netherlands
Erasmus Medical Center, Rotterdam, , Netherlands
The NSMP-ORANGE trial: Barts Health NHS Trust, London, , United Kingdom
The NSMP-ORANGE trial: Manchester Academic Health Science Centre, St Mary's Hospita, Manchester, , United Kingdom
Contact Details
Name: Alexandra Leary, Md PhD
Affiliation: Institute Gustave Roussy, Villejuif, France (p53abn-RED trial)
Role: PRINCIPAL_INVESTIGATOR
Name: Judith R Kroep, MD PhD
Affiliation: Leiden University Medical Center, Leiden, The Netherlands (MMRd-GREEN trial)
Role: PRINCIPAL_INVESTIGATOR
Name: Melanie E Powell, Md PhD
Affiliation: Barts Health NHS Trust, London, United Kingdom (NSMP-ORANGE trial)
Role: PRINCIPAL_INVESTIGATOR
Name: Emma J Crosbie, Md PhD
Affiliation: St Mary's Hospital, Manchester, United Kingdom (NSMP-ORANGE trial)
Role: PRINCIPAL_INVESTIGATOR
Name: Kathy Han, Md PhD
Affiliation: Princess Margaret Cancer Centre, University of Toronto, Toronto, Canada (POLEmut-BLUE trial)
Role: PRINCIPAL_INVESTIGATOR
Name: Jessica N McAlpine, Md PhD
Affiliation: University of British Columbia,Vancouver, Canada (POLEmut-BLUE trial)
Role: PRINCIPAL_INVESTIGATOR
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