Refining Adjuvant Treatment IN Endometrial Cancer Based On Molecular Features
ConditionEndometrial Cancer
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorLeiden University Medical Center
About this trial
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
Qualifiers
None
Disqualifiers
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 (CT scan of chest, abdomen and pelvis or whole-body PET-CT scan)
Trial design
Treatments tested in this trial
- Olaparib
- Pelvic external beam radiotherapy
- Chemotherapy
- Durvalumab
- Medroxyprogesterone Acetate
- Megestrol Acetate
- Vaginal brachytherapy
- Observation
Treatment groups
1,615 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Leiden University Medical Center
Lead sponsor
Institute Gustave Roussy (sponsor p53abn-RED trial)
Collaborator
Leiden University Medical center (sponsor MMRd-GREEN trial)
Collaborator
University College London (sponsor NSMP-ORANGE trial)
Collaborator
Canadian Clinical Trials Group (sponsor POLEmut-BLUE trial)
Collaborator
Dutch Gynaecological Oncology Group
Collaborator
Comprehensive Cancer Centre The Netherlands
Collaborator
Cancer Research UK & UCL Cancer Trials Centre
Collaborator
Dutch Cancer Society
Collaborator
AstraZeneca
Collaborator
National Cancer Institute, France
Collaborator
Canadian Institutes of Health Research (CIHR)
Collaborator
Source ClinicalTrials.gov