drugset / Trial / NCT05255653
Refining Adjuvant Treatment IN Endometrial Cancer Based On Molecular Features
Phase 3
Recruiting
316 enrolled
Leiden University Medical Center
AstraZeneca · collabBGOG: Belgian Gynaelogical Onology Group, Belgium · collabCanadian Cancer Trials Group (CCTG) · collabCanadian Institutes of Health Research (CIHR) · collabCancer Research UK & UCL Cancer Trials Centre · collabCentral & Eastern European Gynecologic Oncology Group (CEEGOG) · collabDutch Cancer Society · collabDutch Gynaecological Oncology Group · collabFondazione Policlinico Universitario Agostino Gemelli IRCCS · collabInstitute Gustave Roussy Paris · collabNational Cancer Institute, France · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
RAINBO MMRd-GREEN 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 with or without chemotherapy.
Timeline
- Start
- 2021-11-11
- Primary completion
- 2030-01-01
- Completion
- 2031-01-01
Outcome
Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)
paper main results are expected from 2028. PMID 36600534 ↗
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 |
|---|---|---|---|---|
| Comparator | Carboplatin | Small molecule | 5 unknown | Intravenous |
| Comparator | Cisplatin | Other / unclassified | 50 mg/m2 | Intravenous |
| Subject | Durvalumab | Monoclonal antibody | 1500 mg | Intravenous |
| Comparator | Paclitaxel | Small molecule | 175 mg/m2 | Intravenous |