NCT05255653: RAINBO

Refining Adjuvant Treatment IN Endometrial Cancer Based On Molecular Features

Recruiting now Phase 2, PHASE3 Last updated 29 November 2024

What this trial tests

Phase 2, PHASE3 trial testing Olaparib in Endometrial Cancer in 1,615 participants. Currently enrolling.

Timeline

11 November 2021

Primary endpoint
1 January 2030

1 January 2031

Quick facts

Lead sponsor	Leiden University Medical Center
Phase	Phase 2, PHASE3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	1,615
Start date	11 November 2021
Primary completion	1 January 2030
Estimated completion	1 January 2031
Sites	14 locations across France, Canada, United Kingdom, Netherlands

Drugs / interventions tested

• Olaparib (olaparib) — full drug profile →
• Pelvic external beam radiotherapy
• Chemotherapy
• Durvalumab — full drug profile →
• Medroxyprogesterone Acetate — full drug profile →
• Megestrol Acetate (MEGESTROL ACETATE) — full drug profile →
• Vaginal brachytherapy
• Observation

Conditions studied

• Endometrial Cancer — all drugs for Endometrial Cancer →

Sponsor

Leiden University Medical Center

Who can join

18 and older, female only, with Endometrial Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. FIGO staging of endometrial cancer: 2023.
   Berek JS, Matias-Guiu X, Creutzberg C, Fotopoulou C, et al · · 2023 · cited 155× · PMID 37593813 · DOI 10.3802/jgo.2023.34.e85
2. Refining adjuvant treatment in endometrial cancer based on molecular features: the RAINBO clinical trial program.
   RAINBO Research Consortium. · · 2023 · cited 139× · PMID 36600534 · DOI 10.1136/ijgc-2022-004039
3. Prognostic refinement of NSMP high-risk endometrial cancers using oestrogen receptor immunohistochemistry.
   Vermij L, Jobsen JJ, León-Castillo A, Brinkhuis M, et al · · 2023 · cited 130× · PMID 36690721 · DOI 10.1038/s41416-023-02141-0
4. Endometrial cancer: molecular classification and future treatments.
   Corr B, Cosgrove C, Spinosa D, Guntupalli S. · · 2022 · cited 66× · PMID 36936577 · DOI 10.1136/bmjmed-2022-000152
5. Characterization of mismatch-repair/microsatellite instability-discordant endometrial cancers.
   Riedinger CJ, Esnakula A, Haight PJ, Suarez AA, et al · · 2024 · cited 60× · PMID 37751191 · DOI 10.1002/cncr.35030
6. Can Cisplatin Therapy Be Improved? Pathways That Can Be Targeted.
   Ali R, Aouida M, Alhaj Sulaiman A, Madhusudan S, et al · · 2022 · cited 51× · PMID 35806243 · DOI 10.3390/ijms23137241
7. Molecular Classification of Endometrial Cancer and Its Impact on Therapy Selection.
   Galant N, Krawczyk P, Monist M, Obara A, et al · · 2024 · cited 46× · PMID 38892080 · DOI 10.3390/ijms25115893
8. Translating biological insights into improved management of endometrial cancer.
   How JA, Jazaeri AA, Westin SN, Lawson BC, et al · · 2024 · cited 25× · PMID 39198622 · DOI 10.1038/s41571-024-00934-7