Radiotherapy with progestin tablets versus radiotherapy with chemotherapy in endometrial cancer
Compares two after-surgery treatments in high-risk endometrial cancer without a specific molecular profile.
Plain-language title generated from the registry record
Registry title: Refining Adjuvant Treatment IN Endometrial Cancer Based On Molecular Features (RAINBO) - NSMP-ORANGE Trial: Comparing Radiotherapy With Oral Progestin Tablets vs. the Current Standard Care, Radiotherapy and Chemotherapy, in Patients With NSMP Endometrial Cancer
Key facts
- Where
- Bath, Cheltenham, Leicester, London, Manchester, Middlesbrough, Oxford, Portsmouth, Southampton, and Sutton, United KingdomSee the 12 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women with high-risk endometrial cancer of the NSMP type who have had surgery and need further treatment. It compares radiotherapy plus progestin tablets with radiotherapy plus chemotherapy.
- Age
- 18 years or older
- Sex
- Women only
- Disease stage
- FIGO (2018) stage II endometrial cancer with substantial LVSI, or stage III NSMP tumours. No macroscopic residual disease after surgery and no distant metastases.
- Earlier treatment
- Must have had a hysterectomy and removal of both tubes and ovaries. Adjuvant treatment is expected to start within 10 weeks after surgery. No prior pelvic radiation.
- Biomarker or test result
- NSMP tumour: p53 wildtype, MMR proficient, no somatic pathogenic POLE variant. ER positive by IHC (10% threshold) or Allred score of 3 or more.
Main reasons for not taking part
- Another cancer in the past 5 years (except non-melanoma skin cancer)
- Prior pelvic radiation
- Artery or blood clot events (such as heart attack, pulmonary embolism or deep vein thrombosis) in the past 6 months
- Poor kidney function, uncontrolled heart disease, or peripheral neuropathy grade 2 or higher
- Taking part in another interventional trial or receiving an investigational drug
Read by machine on 9 November 2026.
Where in United Kingdom
- Royal United Hospitals BathBath, United KingdomTaking people
- Cheltenham GeneralCheltenham, United KingdomTaking people
- Leicester Royal InfirmaryLeicester, United KingdomTaking people
- Bartholemew's HospitalLondon, United KingdomTaking people
- Royal Marsden (Chelsea)London, United KingdomTaking people
- University College London Hospital (UCLH)London, United KingdomTaking people
- The ChristieManchester, United KingdomTaking people
- James Cook University HospitalMiddlesbrough, United KingdomTaking people
- ChurchillOxford, United KingdomTaking people
- Queen Alexandra HospitalPortsmouth, United KingdomTaking people
- University Hospital SouthamptonSouthampton, United KingdomTaking people
- Royal Marsden - SuttonSutton, United KingdomTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University College, London
- Trial code
- NCT07831902
- Record updated
- 21 September 2026
- Original description
RAINBO NSMP-ORANGE aims to investigate if adjuvant radiotherapy with oral progestin tablets is as effective as radiotherapy with chemotherapy, whilst reducing toxicity and thus improving quality of life, in patients with high-risk NSMP endometrial cancer. Patients will be randomised to radiotherapy with chemotherapy (standard of care), or radiotherapy followed by oral progestin tablets.Read full original descriptionShow less
Refining Adjuvant Treatment IN Endometrial Cancer Based On Molecular Features (RAINBO) No Specific Molecular Profile (NSMP) - ORANGE Trial
RAINBO NSMP-ORANGE aims to investigate if adjuvant radiotherapy with oral progestin tablets is as effective as radiotherapy with chemotherapy, whilst reducing toxicity and thus improving quality of life, in patients with high-risk NSMP endometrial cancer. Patients will be randomised to radiotherapy with chemotherapy (standard of care), or radiotherapy followed by oral progestin tablets.
Inclusion: Written informed consent and consent for data sharing for the overarching RAINBO programme; 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, adapted from Vermij et al. 2020); Hysterectomy and bilateral salpingo-oophorectomy 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 scan of chest, abdomen and pelvis within 8 weeks of randomisation). Whole-body PET-CT scan is acceptable if this is part of standard of care at participating sites; Age ≥ 18 years; WHO performance status 0 or 1; Expected start of adjuvant treatment within 10 weeks after surgery; Patients must be accessible for treatment and follow-up; Consent for the donation of a tissue block for translational research for the overarching RAINBO programme; FIGO (2018) stage II EC with substantial LVSI or stage III NSMP tumours; p53 wildtype, MMR proficient EC with no somatic pathogenic POLE variant (i.e. NSMP); ER+ by IHC (10% threshold applied) or Allred score of ≥3; Absolute neutrophil count (ANC) ≥1.5 x 109 /l; Platelets ≥ 100 x 109 /L; Bilirubin ≤ 1.5 x UNL (or ≤ 3 x ULN for cases of known Gilbert's syndrome); AST/ALT ≤ 2.5 x UNL.
Exclusion: Prior pelvic radiation; Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction) within previous 6 months; Thromboembolic event, e.g. pulmonary embolism or deep vein thrombosis, within previous 6 months; Patients who have received a live attenuated vaccine within 2 weeks prior to planned treatment start; The patient is currently participating in another interventional clinical trial or has received an investigational drug (either approved or not approved) in any prior clinical study within 5 half-lives prior to screening; Previous malignancy, except for non-melanoma skin cancer, in the past 5 years; Uncontrolled cardiac disease (defined as cardiac function which would preclude hydration during cisplatin administration and any contraindication to paclitaxel); Inflammatory bowel disease; Known history of porphyria; Any other condition which as per section 4.3 of the relevant SmPC or in the opinion of the investigator contraindicates the use of chemotherapy, radiotherapy and/or oral progestin tablets; Impaired renal function: ≤50ml/min (EDTA clearance, or measured creatinine clearance) or creatinine clearance ≤60 ml/min (calculated according to Cockcroft gault); History of active immune deficiency syndromes or uncontrolled HIV infection: HIV positive patients receiving effective antiretroviral therapy and CD4 count >200 may be included; Peripheral neuropathy, ≥ grade 2.