At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Pelvic external beam radiotherapy (radiation), Chemotherapy (drug), Durvalumab (drug), Vaginal brachytherapy (radiation)
- How long the study runs
- Study runs about 110 months (dates as stated)
- About the drug or intervention
- Pelvic external beam radiotherapy — radiation: 45.0-48.6 Gy; 1.8-2.0 Gy per fraction, 5 fractions a week · Chemotherapy — drug: 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 — drug: 1500 mg intravenous once every 4 weeks for in total 1 year (13 cycles) starting within the first week of radiotherapy, · Vaginal brachytherapy — radiation: Vaginal brachytherapy is to be considered in patients with documented cervical stromal involvement and/or substantial LVSI.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- Female
- Number of participants
- 316
- Started
- 2021-11-11
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for endometrial cancer
- • Phase3 - 316 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with endometrial cancer
- • Female only
Where?
- • No UK sites listed for this trial
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
The MMRd-GREEN trial (NCT05255653) 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. There are three other RAINBO trials, which are registered separately: The p53abn-RED trial (NCT06712472) is an international, multicenter, phase III randomised trial wherein patients with completely resected invasive stage I-III p5abn endometrial cancer and treated with adjuvant chemoradiation will be randomized between olaparib for one year and observation. The NSMP-ORANGE trial (NCT07831902) is an international, multicenter, non-inferiority phase III randomised trial wherein patients with stage II (with substantial LVSI) or stage III no-specific molecular profile (NSMP) endometrial cancer are randomised between standard chemoradiation and external beam radiotherapy followed by oral progestin for two years. The POLEmut-BLUE trial (NCT05640999) is an international, multicenter, single arm, phase II trial wherein safety of de-escalation of adjuvant therapy in POLE-mutated endometrial cancer is investigated. The overarching RAINBO research project will combine the data and tumor material of the four RAINBO clinical trials to perform translational research and compare molecular profile-based adjuvant therapy to standard adjuvant therapy in terms of effectiveness, toxicity, quality of life and cost utility.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: Female only
Biomarkers mentioned
What the study is looking for
- ✓Written agreement to take part
- ✓WHO Performance score 0-1
- ✓Molecular classification: MMRd EC\*
- ✓No prior pelvic radiotherapy
- ✓Body weight \> 30 kg
Who cannot take part
- ✗Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of Investigational...
- ✗History of allogenic organ transplantation.
- ✗Any previous treatment with a PD(L)1 inhibitor, including durvalumab.
- ✗Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab with the...
- ✗Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection).
See the full criteria
How to Get in Touch
Elma Meershoek- Klein Kranenbarg
Sponsor contactCONTACT
Annet Roodvoets
Sponsor contactCONTACT
