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Adjuvant Therapy in POLE-Mutated and p53-Wildtype/NSMP Early Stage Endometrial Cancer RAINBO BLUE & TAPER
RecruitingPhase 2
A Phase II Study of Tailored Adjuvant Therapy in POLE-Mutated and p53-Wildtype/NSMP Early Stage Endormetrial Cancer (RAINBO BLUE & TAPER)
Who can join
Ages 18 and older · Women
Full eligibility criteria
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.
About the study
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
What is being tested
- Vaginal brachytherapy (radiation)
- Adjuvant radiotherapy (EBRT +/- brachytherapy) (radiation)
- Observation (other)
Sponsor: Canadian Cancer Trials Group · Participants: 393 · Started: Dec 19, 2022
Contact the study team
Official record on ClinicalTrials.gov — NCT05640999
Locations in the U.S.
| Alaska | Alaska Womens Cancer Care, Anchorage |
| Arizona | University of Arizona Cancer Center, Tucson |
| California | Cedars-Sinai Medical Center, Los Angeles Huntington Memorial Hospital, Pasadena Sutter Medical Center Sacramento, Sacramento |
| Colorado | UCHealth University of Colorado Hospital, Aurora AdventHealth Porter, Denver |
| Florida | UM Sylvester Comprehensive Cancer Center at, Deerfield Beach UM Sylvester Comprehensive Cancer Center at Doral, Doral University of Florida, Gainesville University of Miami School of Medicine, Miami Sarasota Memorial Hospital - Venice, N. Venice University of Miami Sylvester, North Miami UM Sylvester Comprehensive Cancer Center, Plantation First Physicians Group-Sarasota, Sarasota Florida Cancer Specialists - Sarasota Downtown, Sarasota Sarasota Memorial Health Care Centre, Sarasota Sarasota Memorial Hospital, Sarasota Florida Cancer Specialists - Venice Pinebrook, Venice |
| Georgia | Emory Saint Josephs Hospital, Atlanta Emory University Hospital Midtown, Atlanta Emory University Hospital Winship Cancer Institute, Atlanta Grady Health System, Atlanta Piedmont Hospital, Atlanta Emory Decatur Hospital, Decatur |
| Illinois | Northwestern University, Chicago Northwestern Medicine Orland Park, Orland Park Northwestern Medicine Cancer Center Warrenville, Warrenville |
| Indiana | Ascension Saint Vincent Indianapolis Hospital, Indianapolis |
| Kentucky | Norton Hospital Pavilion and Medical Campus, Louisville Norton Suburban Hospital and Medical Campus, Louisville |
| Louisiana | University Medical Center New Orleans, New Orleans |
| Massachusetts | Massachusetts General Hospital Cancer Center, Boston Baystate Medical Center, Springfield UMass Memorial Medical Centre, Worcester |
| Minnesota | Mercy Hospital, Coon Rapids |
| Missouri | Washington University School of Medicine, St Louis |
| Nebraska | Nebraska Methodist Hospital, Omaha |
| Nevada | Womens Cancer Center of Nevada, Las Vegas |
| New Jersey | Sidney Kimmel Cancer Center Washington Township, Sewell |
| New York | Roswell Park Cancer Institute, Buffalo Mount Sinai Chelsea, New York Mount Sinai Hospital, New York Upstate Cancer Center Radiation Oncology at Oswego, Oswego State University of New York, Syracuse Upstate Cancer Center at Hill Radiation Oncology, Syracuse Upstate Cancer Center at Verona, Verona |
| North Carolina | UNC Lineberger Comprehensive Cancer Center, Chapel Hill Duke University Medical Center, Durham Duke Womens Cancer Care Raleigh, Raleigh |
| Ohio | UHHS-Chagrin Highlands Medical Center, Beachwood Geauga Hospital, Chardon Case Western Reserve University, Cleveland Ohio State University Comprehensive, Columbus UH Seidman Cancer Center, Mentor University Hospitals Parma Medical Center, Parma UH Seidman Cancer Center, Westlake |
| Oklahoma | University of Oklahoma Health Sciences Center, Oklahoma City |
| Oregon | Providence Portland Medical Centre, Portland Providence Saint Vincent Medical Center, Portland |
| Pennsylvania | Penn State Milton S Hershey Medical Center, Hershey Paoli Memorial Hospital, Paoli Thomas Jefferson University, Philadelphia Asplundh Cancer Pavilion, Willow Grove Lankenau Medical Center, Wynnewood |
| Rhode Island | Women and Infants Hospital, Providence |
| Texas | M.D. Anderson Cancer Center, Houston |
| Utah | Farmington Health Centre, Farmington Huntsman Cancer Institute University of Utah, Salt Lake City University of Utah Sugarhouse Health Centre, Salt Lake City |
| Vermont | University of Vermont Medical Center, Burlington University of Vermont and State Agricultural College, Burlington |
| Virginia | University of Virginia Cancer Center, Charlottesville Virginia Commonwealth University, Richmond |
| Washington | Swedish Medical Center First Hill, Seattle |
| Wisconsin | Saint Vincent Hospital Cancer Center Green Bay, Green Bay Medical College of Wisconsin, Milwaukee |
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.