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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
600
Medroxyprogesterone acetate 200mg once daily OR megestrol acetate 160mg once daily following completion of radiotherapy, for 24 months (2 years)
carboplatin and paclitaxel +/- cisplatin, as per standard of care/investigator decision, with radiotherapy
carboplatin and paclitaxel +/- cisplatin, as per standard of care/investigator decision, with radiotherapy
Royal United Hospitals Bath
Bath, United Kingdom
RECRUITINGCheltenham General
Cheltenham, United Kingdom
RECRUITINGLeicester Royal Infirmary
Leicester, United Kingdom
RECRUITINGBartholemew's Hospital
London, United Kingdom
RECRUITINGRoyal Marsden (Chelsea)
London, United Kingdom
RECRUITINGUniversity College London Hospital (UCLH)
London, United Kingdom
RECRUITINGThe Christie
Manchester, United Kingdom
RECRUITINGJames Cook University Hospital
Middlesbrough, United Kingdom
RECRUITINGChurchill
Oxford, United Kingdom
RECRUITINGQueen Alexandra Hospital
Portsmouth, United Kingdom
RECRUITING...and 2 more locations
Recurrence free survival (RFS)
RFS is defined as the time from date of randomisation to date of recurrence or death from any cause.
Time frame: 3 years
Recurrence free survival (RFS)
RFS is defined as the time from date of randomisation to date of recurrence or death from any cause.
Time frame: 5 years
Vaginal recurrence free survival (RFS)
Defined as the time from date of randomisation to date of vaginal recurrence.
Time frame: 3 years, 5 years
Pelvic recurrence free survival (RFS)
Defined as the time from date of randomisation to date of pelvic recurrence.
Time frame: 3 years, 5 years
Para-aortic nodal recurrence free survival (RFS)
Defined as the time from date of randomisation to date of para-aortic nodal recurrence
Time frame: 3 years, 5 years
Distant recurrence free survival (RFS)
Defined as the time from date of randomisation to date of distant recurrence
Time frame: 3 years, 5 years
Cancer-specific survival
Defined as the time from date of randomisation to date of cancer-related death
Time frame: 3 years, 5 years
Overall survival
Defined as the time from date of randomisation to date of death from any cause
Time frame: 3 years, 5 years
Treatment-related toxicity (using the Common Terminology Criteria for Adverse Events [CTCAE] version 5.0)
Toxicity at any time will be described by trial arm in the safety population which will include all patients who receive any trial treatment.
Time frame: 3 years, 5 years
Health-related quality of life (using the validated common and endometrial cancer European Organization for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaires C30 and EN24)
Time frame: 3 years, 5 years
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