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RECRUITING
NCT05255653
PHASE3

Refining Adjuvant Treatment IN Endometrial Cancer Based On Molecular Features

Sponsor: Leiden University Medical Center

View on ClinicalTrials.gov

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.

Official title: RAINBO: Refining Adjuvant Treatment IN Endometrial Cancer Based On Molecular Features, TransPORTEC Platform Trials - MMRd-GREEN.

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

316

Start Date

2021-11-11

Completion Date

2031-01-01

Last Updated

2026-10-08

Healthy Volunteers

No

Interventions

RADIATION

Pelvic external beam radiotherapy

45.0-48.6 Gy; 1.8-2.0 Gy per fraction, 5 fractions a week

DRUG

Chemotherapy

Preferably concurrent and adjuvant according to the PORTEC-3 schedule: two cycles of intravenous cisplatin 50mg/m² in the first and fourth week of the pelvic external beam radiotherapy followed by four cycles of intravenous carboplatin AUC 5 and paclitaxel 175 mg/m² at 21-day intervals.

DRUG

Durvalumab

1500 mg intravenous once every 4 weeks for in total 1 year (13 cycles) starting within the first week of radiotherapy,

RADIATION

Vaginal brachytherapy

Vaginal brachytherapy is to be considered in patients with documented cervical stromal involvement and/or substantial LVSI. Brachytherapy is given with a vaginal cylinder or vaginal ovoids or ring applicator, according to the center's standard technique. When using a cylinder, the active length will ideally be 2-3 cm, with the reference isodose covering the proximal 2.5-3 cm of the vagina. High-dose-rate (HDR) and pulse-dose-rate (PDR) schedules are permitted, which deliver an EQD2 equivalent dose of 10-14 Gy at 5 mm from the vaginal mucosa (to obtain a cumulative EDQ2 of 60 Gy at 5 mm).

Locations (60)

Antwerp University Hospital

Antwerp, Belgium

Clinique Universitaire Saint-Luc

Brussels, Belgium

GHDC

Charleroi, Belgium

CHU Helora

Mons, Belgium

CHU UCL Namur

Namur, Belgium

AZ Damiaan

Ostend, Belgium

Juravinski Cancer Center

Hamilton, Canada

BCCA Kelowna

Kelowna, Canada

Kingston Health Sciences Centre

Kingston, Canada

London Regional Cancer Centre

London, Canada

Centre Hospitalier de Universite de Montreal

Montreal, Canada

Jewish General Hospital

Montreal, Canada

Maisonneuve-Rosemont Hospital

Montreal, Canada

Allan Blair Cancer Centre

Regina, Canada

Saint John Regional Center

Saint John, Canada

Saskatoon Cancer Centre

Saskatoon, Canada

Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Canada

Princess Margaret Cancer Centre

Toronto, Canada

Sunnybrook Health Science Centre

Toronto, Canada

BC Cancer Vancouver

Vancouver, Canada

BCCA Victoria

Victoria, Canada

Fakultní nemocnice Hradec Králové

Hradec Králové, Czechia

FN Bulovka

Prague, Czechia

FN Motol

Prague, Czechia

Všeobecná fakultní nemocnice v Praze

Prague, Czechia

CHU Jean Minjoz

Besançon, France

Institut Bergonie

Bordeaux, France

Institut Leon Berard

Lyon, France

Institut Paoli Calmattes-Marseille

Marseille, France

Institut du cancer de Montpellier

Montpellier, France

Centre Antoine Lacassagne

Nice, France

ICO Saint Herblain

Saint-Herblain, France

Clinique Sainte-Anna

Strasbourg, France

Institut Universitaire de Cancer de Toulouse

Toulouse, France

Institute Gustave Roussy

Villejuif, France

Evangelisches Waldkrankenhaus Spandau Berlin

Berlin, Germany

Klinikum Lippe

Detmold, Germany

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

Universitätsklinikum Heidelberg

Heidelberg, Germany

Klinikum Kempten

Kempten, Germany

Ludwigsburg

Ludwigsburg, Germany

Rotkreuzklinikum München

München, Germany

Diakoneo Diakonie-Klinikum Schwäbisch Hall

Schwäbisch Hall, Germany

Universitätsklinik Tübingen

Tübingen, Germany

Universitätsklinikum Ulm

Ulm, Germany

Klinikum Worms

Worms, Germany

Policlinico Universitario Fondazione Agostino Gemelli

Roma, Italy

Amsterdam University Medical Center

Amsterdam, Netherlands

Amphia Ziekenhuis

Breda, Netherlands

Instituut Verbeeten

Breda, Netherlands

Catharina Ziekenhuis

Eindhoven, Netherlands

Medisch Spectrum Twente

Enschede, Netherlands

Universitair Medisch Centrum Groningen

Groningen, Netherlands

MCL

Leeuwarden, Netherlands

RIF

Leeuwarden, Netherlands

Leiden University Medical Center

Leiden, Netherlands

Maastro

Maastricht, Netherlands

MUMC

Maastricht, Netherlands

Erasmus Medical Center

Rotterdam, Netherlands

UMCU

Utrecht, Netherlands