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
Sponsor: University College, London • ClinicalTrials.gov ID: NCT07831902
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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.
Interventions
-
medroxyprogesterone acetate tablets OR megestrol acetate
(Drug)
Medroxyprogesterone acetate 200mg once daily OR megestrol acetate 160mg once daily following completion of radiotherapy, for 24 months (2 years)
-
Cisplatin
(Drug)
carboplatin and paclitaxel +/- cisplatin, as per standard of care/investigator decision, with radiotherapy
-
Carboplatin + Paclitaxel
(Drug)
carboplatin and paclitaxel +/- cisplatin, as per standard of care/investigator decision, with radiotherapy
Eligibility criteria
Conditions
Locations
- Royal United Hospitals Bath — Bath, United Kingdom
- Cheltenham General — Cheltenham, United Kingdom
- Leicester Royal Infirmary — Leicester, United Kingdom
- Bartholemew's Hospital — London, United Kingdom
- Royal Marsden (Chelsea) — London, United Kingdom
- University College London Hospital (UCLH) — London, United Kingdom
- The Christie — Manchester, United Kingdom
- James Cook University Hospital — Middlesbrough, United Kingdom
- Churchill — Oxford, United Kingdom
- Queen Alexandra Hospital — Portsmouth, United Kingdom
- University Hospital Southampton — Southampton, United Kingdom
- Royal Marsden (Sutton) — Sutton, United Kingdom
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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