RAINBO NSMP - ORANGE: Refining Adjuvant treatment IN endometrial cancer Based On molecular features (RAINBO) TransPORTEC platform trials. RAINBO - Non Specific molecular profile (NSMP) - ORANGE trial
Description
Design:
NSMP-ORANGE is a phase III, randomised controlled trial of chemoradiation against radiotherapy with hormone therapy in patients with endometrial cancer.
Treatment:
Patients will be randomised to receive current standard of care chemoradiation (2 cycles of cisplatin during radiotherapy followed by 4 cycles of carboplatin and paclitaxel) or 4 weeks of radiotherapy followed by oral progestin for 2 years.
Key inclusion/exclusion criteria:
Inclusion
- Written informed consent
- Histologically confirmed diagnosis of endometrial cancer
- Hysterectomy and bilateral salpingo-oophorectomy
- No distant metastases
- Aged 18 or over
- Donation of tissue block
- p53 wildtype, MMR proficient with no somatic pathogenic POLE variant (i.e NSMP)
- ER+ by ICH
Exclusion- History of another primary malignancy
- Prior pelvic radiation
- Contraindication to trial medication
Duration of recruitment:
5 years
Aim
NSMP-ORANGE aims to investigate whether adjuvant radiotherapy with maintenance progestin tablets is as effective as chemoradiotherapy, whilst reducing toxicity and thus improving quality of life, in patients with high-risk NSMP endometrial cancer.