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Looking for participantsPhase3

Refining Adjuvant Treatment IN Endometrial Cancer Based On Molecular Features

Sponsor: Leiden University Medical Center

NCT ID: NCT05255653

View on ClinicalTrials.gov ↗

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.

Endometrial Cancer

How this trial compares with your answers

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What we know so far

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Still need:

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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

known positivePatients positivereaction is negative

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
Participants of the four RAINBO trials should be eligible according to the inclusion and exclusion criteria of both the overarching RAINBO trials program and the clinical trial that they are assigned to based on the molecular profile. Inclusion Criteria of the overarching RAINBO program: * Histologically confirmed diagnosis of endometrial cancer (EC) of the following histotypes: endometrioid endometrial carcinoma, serous endometrial carcinoma, uterine clear cell carcinoma, dedifferentiated and undifferentiated endometrial carcinoma, uterine carcinosarcoma and mixed endometrial carcinomas of the aforementioned histotypes. * Full molecular classification performed following the diagnostic algorithm described in WHO 2020 (5th Edition, IARC, Lyon, 2020) * TLH-BSO or TAH-BSO with or without lymphadenectomy or sentinel node biopsy, without macroscopic residual disease after surgery * No distant metastases as determined by pre-surgical or post-surgical imaging (CT/MRI scan of chest, abdomen and pelvis or PET-CT scan) * Age ≥ 18 years * Expected start of adjuvant treatment (if applicable) within 10 weeks after surgery * Patients must be accessible for treatment and follow-up * Written informed consent for participation in one of the RAINBO trials, permission for the contribution of a tissue block for translation research and permission for the use and sharing of data for the overarching research project according to the local Ethics Committee requirements. Exclusion Criteria overarching RAINBO program: * History of another primary malignancy, except for non-melanoma skin cancer, in the past 5 years * Prior pelvic radiation The MMRd-GREEN trial Inclusion criteria: * Written informed consent * WHO Performance score 0-1 * Histologically confirmed FIGO 2009 stage IB/II with LVSI, stage III, or stage IV with limited pelvic peritoneal involvement (FIGO 2023 stage IB with LVSI, stage II with myometrial or cervical stroma involvement and LVSI, or stage III disease) * Molecular classification: MMRd EC\* * No prior pelvic radiotherapy * Body weight \> 30 kg * Adequate systemic organ function: * Creatinine clearance (\> 40 cc/min): Measured creatinine clearance (CL) \>40 mL/min or Calculated creatinine CL\>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance. * Adequate bone marrow function : hemoglobin \>9.0 g/dl, Absolute neutrophil count (ANC) ≥1.0 x 109/l, platelet count ≥75 x 109/l. * Adequate liver function: Bilirubin ≤1.5 x institutional upper limit of normal (ULN). \<\<This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.\>\> * ALT (SGPT) and/or AST (SGOT) ≤2.5 x ULN Exclusion criteria: * Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of Investigational medicinal product (IMP). * History of allogenic organ transplantation. * Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent. * Any previous treatment with a PD(L)1 inhibitor, including durvalumab. * Receipt of live attenuated vaccine within 30 days prior to the first dose of durvalumab. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IMP. * Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab with the exceptions of : * Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection). * Systemic corticosteroids at physiologic doses not to exceed \<\<10 mg/day\>\> of prednisone or its equivalent. * Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication). * History of active primary immunodeficiency * Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[e.g., colitis or Crohn's disease\], diverticulitis \[with the exception of diverticulosis\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome. The following are exceptions to this criterion: * Patients with vitiligo or alopecia * Patients with hypothyroidism (e.g., following Hashimoto syndrome)stable on hormone replacement * Any chronic skin condition that does not require systemic therapy * Patients without active disease in the last 5 years may be included but only after consultation with the study physician. * Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C, or human immuno-deficiency virus (positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \[anti-HBc\] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA. * Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent.

How to Get in Touch

Elma Meershoek- Klein Kranenbarg

Sponsor contact

CONTACT

0031 71 526 3500 ClinicalResearchCenter@lumc.nl

Annet Roodvoets

Sponsor contact

CONTACT

ClinicalResearchCenter@lumc.nl
Data sourced from ClinicalTrials.gov · Last verified: 2026-10