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

Last updated: August 11, 2025
Sponsor: Canadian Cancer Trials Group
Overall Status: Active - Recruiting

Phase

2

Condition

Vaginal Cancer

Endometrial Cancer

Pelvic Cancer

Treatment

Observation

Adjuvant radiotherapy (EBRT +/- brachytherapy)

Vaginal brachytherapy

Clinical Study ID

NCT05640999
EN10
NRG-GY032
  • Ages > 18
  • Female

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 Criteria

Inclusion

Inclusion Criteria:

  • Patients must have had surgery consisting of hysterectomy and bilateralsalpingo-oophorectomy. Lymph node dissection can be performed as per institutionalstandards. There must be no macroscopic residual disease after surgery.

  • Patients must have histologically confirmed Stage I to III endometrial carcinomawhich can be endometrioid, serous, clear cell, un/dedifferentiated, carcinosarcomaor mixed.

  • Patients' Eastern Cooperative Group (ECOG) performance status must be 0, 1, or 2.

  • HIV-infected patients on effective anti-retroviral therapy with undetectable viralload within 6 months are eligible for this trial.

  • Patients' age must be ≥ 18 years.

  • Patient consent must be appropriately obtained in accordance with applicable localand regulatory requirements.

  • Patient is able (i.e. sufficiently fluent) and willing to complete thepatient-reported outcomes (PRO) questionnaires in either English, French or avalidated language

  • Patients must be accessible for treatment and follow-up. Patients enrolled on thistrial must be treated and followed at the participating centre

  • Protocol treatment is to begin within 10 weeks of hysterectomy/bilateralsalpingo-oophorectomy

Exclusion

Exclusion Criteria:

  • Prior Neoadjuvant chemotherapy for current endometrial cancer diagnosis.

  • Prior pelvic radiation.

  • Patients with a history of other malignancies, except: carcinoma in-situ withoutevidence of invasive disease when resected, adequately treated non-melanoma skincancer, or other tumours curatively treated with no evidence of disease for ≥ 5years.

  • Clinical evidence of distant metastasis as determined by pre-surgical orpost-surgical imaging (CT scan of chest, abdomen and pelvis or whole-body PET-CTscan)

  • Patients with a documented positive surgical margin.

  • Patients with a documented positive peritoneal washings, if performed.

Study Design

Total Participants: 393
Treatment Group(s): 3
Primary Treatment: Observation
Phase: 2
Study Start date:
December 19, 2022
Estimated Completion Date:
June 30, 2029

Study Description

This study is being done in order to find out if this new approach is better or worse than the usual approach for early-stage endometrial cancer. The usual approach is defined as the care most people get for early-stage endometrial cancer.

The usual approach for patients who are not in a study is treatment with surgery. Tissue that is removed as part of this procedure is analyzed in the pathology laboratory to guide the doctor to decide whether or not additional treatment such as radiation and or chemotherapy should be recommended.

Connect with a study center

  • South Western Sydney Local Health District

    Liverpool, New South Wales 2170
    Australia

    Active - Recruiting

  • Calvary Mater Newcastle Hospital

    Waratah, New South Wales 2298
    Australia

    Active - Recruiting

  • Westmead Hospital

    Westmead, New South Wales 2145
    Australia

    Active - Recruiting

  • Mater Research Institute South Brisbane

    South Brisbane, Queensland 4101
    Australia

    Active - Recruiting

  • The Royal Women's Hospital

    Carlton, Victoria 3053
    Australia

    Site Not Available

  • Monash Medical Centre

    Clayton, Victoria 3168
    Australia

    Active - Recruiting

  • Frankston Hospital

    Frankston, Victoria 3199
    Australia

    Active - Recruiting

  • The Royal Women's Hospital

    Parkville, Victoria 3053
    Australia

    Active - Recruiting

  • The Royal Women's Hospital

    Victoria Park, Victoria 3053
    Australia

    Site Not Available

  • Canberra Hospital

    Garran, ACT 2605
    Australia

    Active - Recruiting

  • Royal Brisbane and Womens Hospital

    Herston, 4029
    Australia

    Active - Recruiting

  • Arthur J.E. Child Comprehensive Cancer Centre

    Calgary, Alberta T2N 5G2
    Canada

    Active - Recruiting

  • Tom Baker Cancer Centre

    Calgary, Alberta T2N 4N2
    Canada

    Active - Recruiting

  • Cross Cancer Institute

    Edmonton, Alberta T6G 1Z2
    Canada

    Active - Recruiting

  • BCCA - Cancer Centre for the Southern Interior

    Kelowna, British Columbia V1Y 5L3
    Canada

    Active - Recruiting

  • BCCA - Kelowna

    Kelowna, British Columbia V1Y 5L3
    Canada

    Active - Recruiting

  • BCCA - Centre for the North

    Prince George, British Columbia V2M 7E9
    Canada

    Active - Recruiting

  • BCCA - Prince George

    Prince George, British Columbia V2M 7E9
    Canada

    Active - Recruiting

  • BCCA - Vancouver

    Vancouver, British Columbia V5Z 4E6
    Canada

    Active - Recruiting

  • BCCA - Vancouver Cancer Centre

    Vancouver, British Columbia V5Z 4E6
    Canada

    Active - Recruiting

  • BCCA - Vancouver Island Cancer Centre

    Victoria, British Columbia V8R 6V5
    Canada

    Active - Recruiting

  • BCCA - Victoria

    Victoria, British Columbia V8R 6V5
    Canada

    Active - Recruiting

  • London Health Sciences Centre Research Inc.

    London, Ontario N6A 5W9
    Canada

    Active - Recruiting

  • London Regional Cancer Program

    London, Ontario N6A 5W9
    Canada

    Active - Recruiting

  • Verspeeten Family Cancer Centre

    London, Ontario N6A 5W9
    Canada

    Active - Recruiting

  • Trillium Health Partners - Credit Valley Hospital

    Mississauga, Ontario L5M 2N1
    Canada

    Active - Recruiting

  • Odette Cancer Centre

    Toronto, Ontario M4N 3M5
    Canada

    Active - Recruiting

  • University Health Network

    Toronto, Ontario M5G 2M9
    Canada

    Active - Recruiting

  • CHUM-Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec H2X 3E4
    Canada

    Active - Recruiting

  • The Jewish General Hospital

    Montreal, Quebec H3T 1E2
    Canada

    Active - Recruiting

  • CIUSSS de l'Estrie - Centre hospitalier

    Sherbrooke, Quebec J1H 5N4
    Canada

    Active - Recruiting

  • Institut Gustave-Roussy

    Villejuif, FR 94805
    France

    Active - Recruiting

  • Institut Universitaire du Cancer de Toulouse - IUCT

    Toulouse, Occitanie 31100
    France

    Site Not Available

  • European Institute of Oncology

    Milan, 20141
    Italy

    Active - Recruiting

  • Radiotherapiegroep

    Arnhem, Gelderland 6815AD
    Netherlands

    Active - Recruiting

  • Maastro clinic (Maastricht UMC)

    Maastricht, Limburg 6229ET
    Netherlands

    Active - Recruiting

  • Catharina ziekenhuis

    Eindhoven, Noord Brabant 5623 EJ
    Netherlands

    Active - Recruiting

  • MC Haaglanden

    Den Haag, South Holland 432
    Netherlands

    Active - Recruiting

  • Leiden University Medical Center (LUMC)

    Leiden, 2333ZA
    Netherlands

    Active - Recruiting

  • Erasmus Medical Center (EMC)

    Rotterdam,
    Netherlands

    Active - Recruiting

  • Auckland City Hospital

    Auckland, 1023
    New Zealand

    Active - Recruiting

  • Christchurch Hospital

    Christchurch, 8140
    New Zealand

    Active - Recruiting

  • Alaska Womens Cancer Care

    Anchorage, Alaska 99508
    United States

    Active - Recruiting

  • University of Arizona Cancer Center

    Tucson, Arizona 85719
    United States

    Active - Recruiting

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Active - Recruiting

  • Huntington Memorial Hospital

    Pasadena, California 91105
    United States

    Active - Recruiting

  • Sutter Medical Center Sacramento

    Sacramento, California 95816
    United States

    Active - Recruiting

  • UCHealth University of Colorado Hospital

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Sarasota Memorial Hospital - Venice

    N. Venice, Florida 34275
    United States

    Active - Recruiting

  • First Physicians Group-Sarasota

    Sarasota, Florida 34239
    United States

    Active - Recruiting

  • Florida Cancer Specialists - Sarasota Downtown

    Sarasota, Florida 34236
    United States

    Active - Recruiting

  • Sarasota Memorial Health Care Centre

    Sarasota, Florida 34243
    United States

    Active - Recruiting

  • Sarasota Memorial Hospital

    Sarasota, Florida 34239
    United States

    Active - Recruiting

  • Florida Cancer Specialists - Venice Pinebrook

    Venice, Florida 34275
    United States

    Active - Recruiting

  • Piedmont Hospital

    Atlanta, Georgia 30309
    United States

    Active - Recruiting

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Northwestern Medicine Cancer Center Warrenville

    Warrenville, Illinois 60555
    United States

    Active - Recruiting

  • Ascension Saint Vincent Indianapolis Hospital

    Indianapolis, Indiana 46260
    United States

    Active - Recruiting

  • University Medical Center New Orleans

    New Orleans, Louisiana 70112
    United States

    Active - Recruiting

  • UMass Memorial Medical Centre

    Worcester, Massachusetts 01605
    United States

    Active - Recruiting

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Womens Cancer Center of Nevada

    Las Vegas, Nevada 89106
    United States

    Active - Recruiting

  • Sidney Kimmel Cancer Center Washington Township

    Sewell, New Jersey 08080
    United States

    Active - Recruiting

  • Mount Sinai Chelsea

    New York, New York 10011
    United States

    Active - Recruiting

  • Mount Sinai Hospital

    New York, New York 10029
    United States

    Active - Recruiting

  • Upstate Cancer Center Radiation Oncology at Oswego

    Oswego, New York 13126
    United States

    Active - Recruiting

  • State University of New York

    Syracuse, New York 13210
    United States

    Active - Recruiting

  • Upstate Cancer Center at Hill Radiation Oncology

    Syracuse, New York 13210
    United States

    Active - Recruiting

  • Upstate Cancer Center at Verona

    Verona, New York 13478
    United States

    Active - Recruiting

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina 27599
    United States

    Active - Recruiting

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • Duke Womens Cancer Care Raleigh

    Raleigh, North Carolina 27607
    United States

    Active - Recruiting

  • Case Western Reserve University

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • Ohio State University Comprehensive

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma 73104
    United States

    Active - Recruiting

  • Providence Portland Medical Centre

    Portland, Oregon 97213
    United States

    Active - Recruiting

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania 17033
    United States

    Active - Recruiting

  • Thomas Jefferson University

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • Asplundh Cancer Pavilion

    Willow Grove, Pennsylvania 19090
    United States

    Active - Recruiting

  • Women and Infants Hospital

    Providence, Rhode Island 02905
    United States

    Active - Recruiting

  • Farmington Health Centre

    Farmington, Utah 84025
    United States

    Active - Recruiting

  • Huntsman Cancer Institute University of Utah

    Salt Lake City, Utah 84112
    United States

    Active - Recruiting

  • University of Utah Sugarhouse Health Centre

    Salt Lake City, Utah 84106
    United States

    Active - Recruiting

  • University of Virginia Cancer Center

    Charlottesville, Virginia 22908
    United States

    Active - Recruiting

  • Virginia Commonwealth University

    Richmond, Virginia 23298
    United States

    Active - Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

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