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Recruiting Phase 2, Phase 3 NCT05255653

Refining Adjuvant Treatment in Endometrial Cancer Based on Molecular Features

Trial Parameters

Condition Endometrial Cancer
Sponsor Leiden University Medical Center
Study Type INTERVENTIONAL
Phase Phase 2, Phase 3
Enrollment 1,615
Sex FEMALE
Min Age 18 Years
Max Age N/A
Start Date 2021-11-11
Completion 2030-01-01
Interventions
OlaparibPelvic external beam radiotherapyChemotherapy

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

Eligibility Criteria

Participants of the four RAINBO trials should be eligible according to the inclusion and exclusion criteria of both the overarching RAINBO trials program and the clinical trial that they are assigned to based on the molecular profile. Inclusion Criteria of the overarching RAINBO program: * Histologically confirmed diagnosis of endometrial cancer (EC) of the following histotypes: 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 (5th Edition, IARC, Lyon, 2020) * Hysterectomy and bilateral salpingo-oophorectomy with or without lymphadenectomy or sentinel node biopsy, without macroscopic residual disease after surgery * No distant metastases as determined by pre-surgical or post-surgical imaging (C

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