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RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Canadian Cancer Trials Group • ClinicalTrials.gov ID: NCT05640999

Registry updated: 2026-10-14
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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-studies * EN10.A/RAINBO BLUE: POLE-mutated EC * EN10.B/TAPER: p53 wildtype / NSMP EC

Interventions

  • Vaginal brachytherapy (Radiation)
    Vaginal brachytherapy should be delivered using a vaginal cylinder, or alternatively ovoids
  • Adjuvant radiotherapy (EBRT +/- brachytherapy) (Radiation)
    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 (Other)
    Observation

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.

Conditions

Endometrial Cancer

Locations

  • Alaska Womens Cancer Care — Anchorage, Alaska, United States
  • University of Arizona Cancer Center — Tucson, Arizona, United States
  • Cedars-Sinai Medical Center — Los Angeles, California, United States
  • Huntington Memorial Hospital — Pasadena, California, United States
  • Sutter Medical Center Sacramento — Sacramento, California, United States
  • UCHealth University of Colorado Hospital — Aurora, Colorado, United States
  • AdventHealth Porter — Denver, Colorado, United States
  • UM Sylvester Comprehensive Cancer Center at — Deerfield Beach, Florida, United States
  • UM Sylvester Comprehensive Cancer Center at Doral — Doral, Florida, United States
  • University of Florida — Gainesville, Florida, United States
  • University of Miami School of Medicine — Miami, Florida, United States
  • Sarasota Memorial Hospital - Venice — N. Venice, Florida, United States
  • University of Miami Sylvester — North Miami, Florida, United States
  • UM Sylvester Comprehensive Cancer Center — Plantation, Florida, United States
  • Florida Cancer Specialists - Sarasota Downtown — Sarasota, Florida, United States
  • First Physicians Group-Sarasota — Sarasota, Florida, United States
  • Sarasota Memorial Hospital — Sarasota, Florida, United States
  • Sarasota Memorial Health Care Centre — Sarasota, Florida, United States
  • Florida Cancer Specialists - Venice Pinebrook — Venice, Florida, United States
  • Grady Health System — Atlanta, Georgia, United States
  • Emory University Hospital Midtown — Atlanta, Georgia, United States
  • Piedmont Hospital — Atlanta, Georgia, United States
  • Emory University Hospital Winship Cancer Institute — Atlanta, Georgia, United States
  • Emory Saint Josephs Hospital — Atlanta, Georgia, United States
  • Emory Decatur Hospital — Decatur, Georgia, United States
  • Northwestern University — Chicago, Illinois, United States
  • Northwestern Medicine Orland Park — Orland Park, Illinois, United States
  • Northwestern Medicine Cancer Center Warrenville — Warrenville, Illinois, United States
  • Ascension Saint Vincent Indianapolis Hospital — Indianapolis, Indiana, United States
  • Norton Hospital Pavilion and Medical Campus — Louisville, Kentucky, United States
  • Norton Suburban Hospital and Medical Campus — Louisville, Kentucky, United States
  • University Medical Center New Orleans — New Orleans, Louisiana, United States
  • Massachusetts General Hospital Cancer Center — Boston, Massachusetts, United States
  • Baystate Medical Center — Springfield, Massachusetts, United States
  • UMass Memorial Medical Centre — Worcester, Massachusetts, United States
  • Mercy Hospital — Coon Rapids, Minnesota, United States
  • Washington University School of Medicine — St Louis, Missouri, United States
  • Nebraska Methodist Hospital — Omaha, Nebraska, United States
  • Womens Cancer Center of Nevada — Las Vegas, Nevada, United States
  • Sidney Kimmel Cancer Center Washington Township — Sewell, New Jersey, United States
  • Roswell Park Cancer Institute — Buffalo, New York, United States
  • Mount Sinai Chelsea — New York, New York, United States
  • Mount Sinai Hospital — New York, New York, United States
  • Upstate Cancer Center Radiation Oncology at Oswego — Oswego, New York, United States
  • State University of New York — Syracuse, New York, United States
  • Upstate Cancer Center at Hill Radiation Oncology — Syracuse, New York, United States
  • Upstate Cancer Center at Verona — Verona, New York, United States
  • UNC Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States
  • Duke University Medical Center — Durham, North Carolina, United States
  • Duke Womens Cancer Care Raleigh — Raleigh, North Carolina, United States
  • UHHS-Chagrin Highlands Medical Center — Beachwood, Ohio, United States
  • Geauga Hospital — Chardon, Ohio, United States
  • Case Western Reserve University — Cleveland, Ohio, United States
  • Ohio State University Comprehensive — Columbus, Ohio, United States
  • UH Seidman Cancer Center — Mentor, Ohio, United States
  • University Hospitals Parma Medical Center — Parma, Ohio, United States
  • UH Seidman Cancer Center — Westlake, Ohio, United States
  • University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
  • Providence Portland Medical Centre — Portland, Oregon, United States
  • Providence Saint Vincent Medical Center — Portland, Oregon, United States
  • Penn State Milton S Hershey Medical Center — Hershey, Pennsylvania, United States
  • Paoli Memorial Hospital — Paoli, Pennsylvania, United States
  • Thomas Jefferson University — Philadelphia, Pennsylvania, United States
  • Asplundh Cancer Pavilion — Willow Grove, Pennsylvania, United States
  • Lankenau Medical Center — Wynnewood, Pennsylvania, United States
  • Women and Infants Hospital — Providence, Rhode Island, United States
  • M.D. Anderson Cancer Center — Houston, Texas, United States
  • Farmington Health Centre — Farmington, Utah, United States
  • University of Utah Sugarhouse Health Centre — Salt Lake City, Utah, United States
  • Huntsman Cancer Institute University of Utah — Salt Lake City, Utah, United States
  • University of Vermont Medical Center — Burlington, Vermont, United States
  • University of Vermont and State Agricultural College — Burlington, Vermont, United States
  • University of Virginia Cancer Center — Charlottesville, Virginia, United States
  • Virginia Commonwealth University — Richmond, Virginia, United States
  • Swedish Medical Center First Hill — Seattle, Washington, United States
  • Saint Vincent Hospital Cancer Center Green Bay — Green Bay, Wisconsin, United States
  • Medical College of Wisconsin — Milwaukee, Wisconsin, United States
  • South Western Sydney Local Health District — Liverpool, New South Wales, Australia
  • Royal North Shore Hospital — St Leonards, New South Wales, Australia
  • Calvary Mater Newcastle Hospital — Waratah, New South Wales, Australia
  • Westmead Hospital — Westmead, New South Wales, Australia
  • Mater Research Institute South Brisbane — South Brisbane, Queensland, Australia
  • Royal Darwin Hospital — Darwin, Tiwi, Australia
  • Monash Medical Centre — Clayton, Victoria, Australia
  • Frankston Hospital — Frankston, Victoria, Australia
  • The Royal Women's Hospital — Parkville, Victoria, Australia
  • Canberra Hospital — Garran, Australia
  • Royal Brisbane and Womens Hospital — Herston, Australia
  • Arthur J.E. Child Comprehensive Cancer Centre — Calgary, Alberta, Canada
  • Cross Cancer Institute — Edmonton, Alberta, Canada
  • BCCA - Kelowna — Kelowna, British Columbia, Canada
  • BCCA - Prince George — Prince George, British Columbia, Canada
  • BCCA - Vancouver — Vancouver, British Columbia, Canada
  • BCCA - Victoria — Victoria, British Columbia, Canada
  • Royal Victoria Regional Health Centre — Barrie, Ontario, Canada
  • Juravinski Cancer Centre at Hamilton Health Sciences — Hamilton, Ontario, Canada
  • London Health Sciences Centre Research Inc. — London, Ontario, Canada
  • Trillium Health Partners - Credit Valley Hospital — Mississauga, Ontario, Canada
  • Odette Cancer Centre — Toronto, Ontario, Canada
  • University Health Network — Toronto, Ontario, Canada
  • CHUM-Centre Hospitalier de l'Universite de Montreal — Montreal, Quebec, Canada
  • The Jewish General Hospital — Montreal, Quebec, Canada
  • CIUSSS de l'Estrie - Centre hospitalier — Sherbrooke, Quebec, Canada
  • Centre Leon Berard — Lyon, Auvergne-Rhône-Alpes, France
  • Institut Gustave-Roussy — Villejuif, FR, France
  • Centre Oscar Lambret — Lille, Nord, France
  • Institut Universitaire du Cancer de Toulouse - IUCT — Toulouse, Occitanie, France
  • Groupe Hospitalier Diaconesses Croix Saint-Simon — Paris, France
  • Diak Klinikum Landkreis Schwaebisch Hall — Schwäbisch Hall, Baden-Wurttemberg, Germany
  • Policliico Careggi — Florence, Florence, Italy
  • ASST Spedali Civili Brescia — Brescia, Italy
  • ASST Lecco — Lecco, Italy
  • European Institute of Oncology — Milan, Italy
  • Policlinico Umberto I, Universita Sapienza — Rome, Italy
  • Radiotherapiegroep — Arnhem, Gelderland, Netherlands
  • Maastro clinic (Maastricht UMC) — Maastricht, Limburg, Netherlands
  • Catharina ziekenhuis — Eindhoven, North Brabant, Netherlands
  • MC Haaglanden — The Hague, South Holland, Netherlands
  • Leiden University Medical Center (LUMC) — Leiden, Netherlands
  • Erasmus Medical Center (EMC) — Rotterdam, Netherlands
  • Auckland City Hospital — Auckland, New Zealand
  • Christchurch Hospital — Christchurch, New Zealand
  • Oslo University Hospital — Oslo, Ullernchausseen 70, Norway
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record