Tests lighter follow-up treatment for early endometrial cancer with certain tumor gene profiles
Tests reduced treatment after surgery in adults with early endometrial cancer.
Plain-language title generated from the registry record
Registry title: Adjuvant Therapy in POLE-Mutated and p53-Wildtype/NSMP Early Stage Endometrial Cancer RAINBO BLUE & TAPER
Key facts
- Where
- Clayton, Darwin, Frankston, Garran, Herston, Liverpool, Parkville, South Brisbane, St Leonards, Waratah, and Westmead, AustraliaSee the 11 sites
- Phase
- Phase 2
Where in Australia
- Monash Medical CentreClayton, AustraliaTaking people
- Royal Darwin HospitalDarwin, AustraliaTaking people
- Frankston HospitalFrankston, AustraliaTaking people
- Canberra HospitalGarran, AustraliaTaking people
- Royal Brisbane and Womens HospitalHerston, AustraliaTaking people
- South Western Sydney Local Health DistrictLiverpool, AustraliaTaking people
- The Royal Women's HospitalParkville, AustraliaTaking people
- Mater Research Institute South BrisbaneSouth Brisbane, AustraliaTaking people
- Royal North Shore HospitalSt Leonards, AustraliaTaking people
- Calvary Mater Newcastle HospitalWaratah, AustraliaTaking people
- Westmead HospitalWestmead, AustraliaTaking 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
- Canadian Cancer Trials Group
- Trial code
- NCT05640999
- Record updated
- 14 October 2026
- Original description
This protocol tests de-escalated adjuvant treatment in patients with POLE-mutated or p53wt/NSMP (p53 wildtype/no specific molecular profile) early-stage endometrial cancer (EC). Patients may be enrolled in one of two sub-studiesRead full original descriptionShow less
A Phase II Study of Tailored Adjuvant Therapy in POLE-Mutated and p53-Wildtype/NSMP Early Stage Endormetrial Cancer (RAINBO BLUE & TAPER)
This protocol tests de-escalated adjuvant treatment in patients with POLE-mutated or p53wt/NSMP (p53 wildtype/no specific molecular profile) early-stage endometrial cancer (EC). Patients may be enrolled in one of two sub-studies
* EN10.A/RAINBO BLUE: POLE-mutated EC * EN10.B/TAPER: p53 wildtype / NSMP EC
Inclusion: Patients must have had surgery consisting of hysterectomy and bilateral salpingo-oophorectomy. Lymph node dissection can be performed as per institutional standards. There must be no macroscopic residual disease after surgery; Patients must have histologically confirmed Stage I to III endometrial carcinoma which can be endometrioid, serous, clear cell, un/dedifferentiated, carcinosarcoma or mixed; Patients' Eastern Cooperative Group (ECOG) performance status must be 0, 1, or 2; HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial; Patients' age must be ≥ 18 years; Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements; Patient is able (i.e. sufficiently fluent) and willing to complete the patient-reported outcomes (PRO) questionnaires in either English, French or a validated language; Patients must be accessible for treatment and follow-up. Patients enrolled on this trial must be treated and followed at the participating centre; Protocol treatment is to begin within 10 weeks of hysterectomy/bilateral salpingo-oophorectomy.
Exclusion: Prior Neoadjuvant chemotherapy for current endometrial cancer diagnosis; Prior pelvic radiation; Clinical evidence of distant metastasis as determined by pre-surgical or post-surgical imaging (CT scan of chest, abdomen and pelvis or whole-body PET-CT scan); Patients with a documented positive surgical margin; Patients with a history of other malignancies, except: carcinoma in-situ without evidence of invasive disease when resected, adequately treated non-melanoma skin cancer, or other tumours curatively treated with no evidence of disease for ≥ 5 years; Patients with a documented positive peritoneal washings, if performed.