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.
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
Previous malignancy, except for non-melanoma skin cancer, in the past 5 years
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
Parallel
medroxyprogesterone acetate tablets OR megestrol acetate
DrugMedroxyprogesterone acetate 200mg once daily OR megestrol acetate 160mg once daily following completion of radiotherapy, for 24 months (2 years)
Cisplatin
Drugcarboplatin and paclitaxel +/- cisplatin, as per standard of care/investigator decision, with radiotherapy
Carboplatin + Paclitaxel
Drugcarboplatin and paclitaxel +/- cisplatin, as per standard of care/investigator decision, with radiotherapy
Recurrence free survival (RFS)
RFS is defined as the time from date of randomisation to date of recurrence or death from any cause.
Recurrence free survival (RFS)
RFS is defined as the time from date of randomisation to date of recurrence or death from any cause.
Vaginal recurrence free survival (RFS)
Defined as the time from date of randomisation to date of vaginal recurrence.
Pelvic recurrence free survival (RFS)
Defined as the time from date of randomisation to date of pelvic recurrence.
Para-aortic nodal recurrence free survival (RFS)
Defined as the time from date of randomisation to date of para-aortic nodal recurrence
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