drugset / Trial / NCT05255653
Refining Adjuvant Treatment IN Endometrial Cancer Based On Molecular Features
Phase 2/3
Recruiting
1615 enrolled
Leiden University Medical Center
AstraZeneca · collabCanadian Clinical Trials Group (sponsor POLEmut-BLUE trial) · collabCanadian Institutes of Health Research (CIHR) · collabCancer Research UK & UCL Cancer Trials Centre · collabComprehensive Cancer Centre The Netherlands · collabDutch Cancer Society · collabDutch Gynaecological Oncology Group · collabInstitute Gustave Roussy (sponsor p53abn-RED trial) · collabLeiden University Medical center (sponsor MMRd-GREEN trial) · collabNational Cancer Institute, France · collabUniversity College London (sponsor NSMP-ORANGE trial) · collab
RandomizedParallel-groupOpen-labelTreatment
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
Timeline
- Start
- 2021-11-11
- Primary completion
- 2030-01-01
- Completion
- 2031-01-01
Publications
- Results IMPLEMENTATION OF COLLABORATIVE TRANSLATIONAL RESEARCH (TRANSPORTEC) FINDINGS IN AN INTERNATIONAL ENDOMETRIAL CANCER CLINICAL TRIALS PROGRAM (RAINBO). T Bosse, M Powell, E Crosbie, A Leary, J Kroep, K Han, J Mcalpine, N Horeweg, S De Boer, M De Bruyn, R Nout, V Smit, HW Nijman, N Singh, H Mackay, R Edmondson, L Mileshkin, D Church, H Kitchener, CL Creutzberg. Int J Gynecol Cancer 2021;31(Suppl 3):A1-A395. DOI: 10.1136/ijgc-2021-ESGO.171
- Results RAINBO Research Consortium. Refining adjuvant treatment in endometrial cancer based on molecular features: the RAINBO clinical trial program. Int J Gynecol Cancer. 2023 Jan 3;33(1):109-117. doi: 10.1136/ijgc-2022-004039.
- Secord AA, Powell MA, McAlpine J. Molecular Characterization and Clinical Implications of Endometrial Cancer. Obstet Gynecol. 2025 Nov 1;146(5):660-671. doi: 10.1097/AOG.0000000000006080. Epub 2025 Sep 18.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Durvalumab | Monoclonal antibody | 1500 mg | Intravenous |
| Subject | Megestrol Acetate | Other / unclassified | — | Oral |
| Subject | Olaparib | Small molecule | 300 mg | — |
| Subject | medroxyprogesterone acetate | Other / unclassified | — | Oral |
| Background | Carboplatin | Small molecule | 5 unknown | Intravenous |
| Background | Cisplatin | Other / unclassified | 50 mg/m2 | Intravenous |
| Background | Paclitaxel | Small molecule | 175 mg/m2 | Intravenous |