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Refining Adjuvant Treatment IN Endometrial Cancer Based On Molecular Features — RAINBO  

Endometrial Cancer Clinical Trial

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

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05255653
Study type Interventional
Source Leiden University Medical Center
Contact Carien L Creutzberg, MD PhD
Phone +31 71 52 65539
Email c.l.creutzberg@lumc.nl
Status Recruiting
Phase Phase 2/Phase 3
Start date November 11, 2021
Completion date January 1, 2031
View Details
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