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Clinical Trials in Australia / NCT05640999
Recruiting Phase 2

Adjuvant Therapy in POLE-Mutated and p53-Wildtype/NSMP Early Stage Endometrial Cancer RAINBO BLUE & TAPER

NCT05640999 · tracked via the Priya Life Science Australia tracker
Phase
Phase 2
Started
2022-12-19
Last updated
2026-09-24

Condition(s) studied

Endometrial Cancer

Investigational drug(s) / intervention(s)

Vaginal brachytherapyAdjuvant radiotherapy (EBRT +/- brachytherapy)Observation

Vaginal brachytherapy: Vaginal brachytherapy should be delivered using a vaginal cylinder, or alternatively ovoids

Adjuvant radiotherapy (EBRT +/- brachytherapy): Treatment is to be delivered using 4-18 MV photons. MV, kV or CBCT imaging capabilities are required. Planning systems with capability for DICOM data transfer must be used.

Observation: Observation

Study summary

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

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * Prior Neoadjuvant chemotherapy for current endometrial cancer diagnosis. * Prior pelvic radiation. * 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. * 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 documented positive peritoneal washings, if performed.

Primary outcome measure(s)

Trial sites (122)

FacilityCityRegionStatus
Alaska Womens Cancer Care Anchorage Alaska Recruiting
University of Arizona Cancer Center Tucson Arizona Recruiting
Cedars-Sinai Medical Center Los Angeles California Recruiting
Huntington Memorial Hospital Pasadena California Recruiting
Sutter Medical Center Sacramento Sacramento California Recruiting
UCHealth University of Colorado Hospital Aurora Colorado Recruiting
AdventHealth Porter Denver Colorado Recruiting
UM Sylvester Comprehensive Cancer Center at Deerfield Beach Florida Recruiting
UM Sylvester Comprehensive Cancer Center at Doral Doral Florida Recruiting
University of Florida Gainesville Florida Recruiting
University of Miami School of Medicine Miami Florida Recruiting
Sarasota Memorial Hospital - Venice N. Venice Florida Recruiting
University of Miami Sylvester North Miami Florida Recruiting
UM Sylvester Comprehensive Cancer Center Plantation Florida Recruiting
Florida Cancer Specialists - Sarasota Downtown Sarasota Florida Recruiting
First Physicians Group-Sarasota Sarasota Florida Recruiting
Sarasota Memorial Hospital Sarasota Florida Recruiting
Sarasota Memorial Health Care Centre Sarasota Florida Recruiting
Florida Cancer Specialists - Venice Pinebrook Venice Florida Recruiting
Grady Health System Atlanta Georgia Recruiting
Emory University Hospital Midtown Atlanta Georgia Recruiting
Piedmont Hospital Atlanta Georgia Recruiting
Emory University Hospital Winship Cancer Institute Atlanta Georgia Recruiting
Emory Saint Josephs Hospital Atlanta Georgia Recruiting
Emory Decatur Hospital Decatur Georgia Recruiting
Northwestern University Chicago Illinois Recruiting
Northwestern Medicine Orland Park Orland Park Illinois Recruiting
Northwestern Medicine Cancer Center Warrenville Warrenville Illinois Recruiting
Ascension Saint Vincent Indianapolis Hospital Indianapolis Indiana Recruiting
Norton Hospital Pavilion and Medical Campus Louisville Kentucky Recruiting
Norton Suburban Hospital and Medical Campus Louisville Kentucky Recruiting
University Medical Center New Orleans New Orleans Louisiana Recruiting
Massachusetts General Hospital Cancer Center Boston Massachusetts Recruiting
Baystate Medical Center Springfield Massachusetts Recruiting
UMass Memorial Medical Centre Worcester Massachusetts Recruiting
Mercy Hospital Coon Rapids Minnesota Recruiting
Washington University School of Medicine St Louis Missouri Recruiting
Nebraska Methodist Hospital Omaha Nebraska Recruiting
Womens Cancer Center of Nevada Las Vegas Nevada Recruiting
Sidney Kimmel Cancer Center Washington Township Sewell New Jersey Recruiting

+ 82 more sites — see the full list on the official registry below.

More Canadian Cancer Trials Group trials in Australia

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05640999 on ClinicalTrials.gov ↗ ← All trials in Australia