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Refining Adjuvant Treatment IN Endometrial Cancer Based On Molecular Features
Sponsor: Leiden University Medical Center
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
Conditions
Interventions
Pelvic external beam radiotherapy
45.0-48.6 Gy; 1.8-2.0 Gy per fraction, 5 fractions a week
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.
Durvalumab
1500 mg intravenous once every 4 weeks for in total 1 year (13 cycles) starting within the first week of radiotherapy,
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