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

NCT05640999 | Recruiting Phase 2 DMC FDA Device

• 2 other identifiers: EN10NRG-GY032
• Study Type: interventional
• Target: 393
• Locations: 8 countries
• Sites: 110

Brief 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

Conditions

Endometrial Cancer

Outcome Measures

Primary Outcomes (1)

• Estimate the rate of pelvic recurrence at 3 years in patients who are treated with de-escalated adjuvant treatment directed by tumour molecular status

  3 years

Secondary Outcomes (7)

• Estimate the rate of isolated vaginal recurrence at 3 years

  3 years

• Estimate the rate of para-aortic recurrence at 3 years

  3 years

• Estimate the rate of distant metastasis at 3 years

  3 years

• Estimate recurrence-free survival

  9 years

• Estimate endometrial cancer-specific survival

  9 years

Study Arms (3)

Sub-study A: RAINBO BLUE Cohort A1

EXPERIMENTAL

Observation

Other: Observation

Sub-Study A: RAINBO BLUE Cohort A2

EXPERIMENTAL

Observation or Adjuvant Radiotherapy

Radiation: Adjuvant radiotherapy (EBRT +/- brachytherapy); Other: Observation

Sub-Study B: TAPER

EXPERIMENTAL

Observation or Vaginal Brachytherapy

Radiation: Vaginal brachytherapy; Other: Observation

Interventions

Vaginal brachytherapy RADIATION

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

Sub-Study B: TAPER

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.

Sub-Study A: RAINBO BLUE Cohort A2

Observation OTHER

Observation

Sub-Study A: RAINBO BLUE Cohort A2; Sub-Study B: TAPER; Sub-study A: RAINBO BLUE Cohort A1

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Leiden University Medical Center: collaborator
• Philipps University Marburg: collaborator
• NRG Oncology: collaborator
• Canadian Cancer Clinical Trials Network: collaborator
• Australia New Zealand Gynaecological Oncology Group: collaborator
• Gustave Roussy, Cancer Campus, Grand Paris: collaborator
• Mario Negri Gynecologic Oncology group (MaNGO): collaborator
• Canadian Cancer Trials Group: lead

Study Sites (110)

Alaska Womens Cancer Care

Anchorage, Alaska, 99508, United States

RECRUITING

University of Arizona Cancer Center

Tucson, Arizona, 85719, United States

RECRUITING

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

Huntington Memorial Hospital

Pasadena, California, 91105, United States

RECRUITING

Sutter Medical Center Sacramento

Sacramento, California, 95816, United States

RECRUITING

UCHealth University of Colorado Hospital

Aurora, Colorado, 80045, United States

RECRUITING

AdventHealth Porter

Denver, Colorado, 80210, United States

RECRUITING

University of Miami School of Medicine

Miami, Florida, 33136, United States

RECRUITING

Sarasota Memorial Hospital - Venice

N. Venice, Florida, 34275, United States

RECRUITING

Florida Cancer Specialists - Sarasota Downtown

Sarasota, Florida, 34236, United States

RECRUITING

First Physicians Group-Sarasota

Sarasota, Florida, 34239, United States

RECRUITING

Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States

RECRUITING

Sarasota Memorial Health Care Centre

Sarasota, Florida, 34243, United States

RECRUITING

Florida Cancer Specialists - Venice Pinebrook

Venice, Florida, 34275, United States

RECRUITING

Grady Health System

Atlanta, Georgia, 30303, United States

RECRUITING

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

RECRUITING

Piedmont Hospital

Atlanta, Georgia, 30309, United States

RECRUITING

Emory University Hospital Winship Cancer Institute

Atlanta, Georgia, 30322, United States

RECRUITING

Emory Saint Josephs Hospital

Atlanta, Georgia, 30342, United States

RECRUITING

Emory Decatur Hospital

Decatur, Georgia, 30033, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Northwestern Medicine Orland Park

Orland Park, Illinois, 60462, United States

RECRUITING

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, 60555, United States

RECRUITING

Ascension Saint Vincent Indianapolis Hospital

Indianapolis, Indiana, 46260, United States

RECRUITING

Norton Hospital Pavilion and Medical Campus

Louisville, Kentucky, 40202, United States

RECRUITING

Norton Suburban Hospital and Medical Campus

Louisville, Kentucky, 40207, United States

RECRUITING

University Medical Center New Orleans

New Orleans, Louisiana, 70112, United States

RECRUITING

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

RECRUITING

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

RECRUITING

UMass Memorial Medical Centre

Worcester, Massachusetts, 01605, United States

RECRUITING

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Nebraska Methodist Hospital

Omaha, Nebraska, 68114, United States

RECRUITING

Womens Cancer Center of Nevada

Las Vegas, Nevada, 89106, United States

RECRUITING

Sidney Kimmel Cancer Center Washington Township

Sewell, New Jersey, 08080, United States

RECRUITING

Mount Sinai Chelsea

New York, New York, 10011, United States

RECRUITING

Mount Sinai Hospital

New York, New York, 10029, United States

RECRUITING

Upstate Cancer Center Radiation Oncology at Oswego

Oswego, New York, 13126, United States

RECRUITING

State University of New York

Syracuse, New York, 13210, United States

RECRUITING

Upstate Cancer Center at Hill Radiation Oncology

Syracuse, New York, 13210, United States

RECRUITING

Upstate Cancer Center at Verona

Verona, New York, 13478, United States

RECRUITING

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Duke University Medical Center

Durham, North Carolina, 27710, United States

RECRUITING

Duke Womens Cancer Care Raleigh

Raleigh, North Carolina, 27607, United States

RECRUITING

UHHS-Chagrin Highlands Medical Center

Beachwood, Ohio, 44122, United States

RECRUITING

Case Western Reserve University

Cleveland, Ohio, 44106, United States

RECRUITING

Ohio State University Comprehensive

Columbus, Ohio, 43210, United States

RECRUITING

UH Seidman Cancer Center

Mentor, Ohio, 44060, United States

RECRUITING

University Hospitals Parma Medical Center

Parma, Ohio, 44129, United States

RECRUITING

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

Providence Portland Medical Centre

Portland, Oregon, 97213, United States

RECRUITING

Providence Saint Vincent Medical Center

Portland, Oregon, 97225, United States

RECRUITING

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

RECRUITING

Paoli Memorial Hospital

Paoli, Pennsylvania, 19301, United States

RECRUITING

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Asplundh Cancer Pavilion

Willow Grove, Pennsylvania, 19090, United States

RECRUITING

Lankenau Medical Center

Wynnewood, Pennsylvania, 19096, United States

RECRUITING

Women and Infants Hospital

Providence, Rhode Island, 02905, United States

RECRUITING

M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Farmington Health Centre

Farmington, Utah, 84025, United States

RECRUITING

University of Utah Sugarhouse Health Centre

Salt Lake City, Utah, 84106, United States

RECRUITING

Huntsman Cancer Institute University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

RECRUITING

University of Vermont and State Agricultural College

Burlington, Vermont, 05405, United States

RECRUITING

University of Virginia Cancer Center

Charlottesville, Virginia, 22908, United States

RECRUITING

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

RECRUITING

Swedish Medical Center First Hill

Seattle, Washington, 98122, United States

RECRUITING

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, 54301, United States

RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

South Western Sydney Local Health District

Liverpool, New South Wales, 2170, Australia

RECRUITING

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

RECRUITING

Calvary Mater Newcastle Hospital

Waratah, New South Wales, 2298, Australia

RECRUITING

Westmead Hospital

Westmead, New South Wales, 2145, Australia

RECRUITING

Mater Research Institute South Brisbane

South Brisbane, Queensland, 4101, Australia

RECRUITING

Monash Medical Centre

Clayton, Victoria, 3168, Australia

RECRUITING

Frankston Hospital

Frankston, Victoria, 3199, Australia

RECRUITING

The Royal Women's Hospital

Parkville, Victoria, 3053, Australia

RECRUITING

Canberra Hospital

Garran, ACT 2605, Australia

RECRUITING

Royal Brisbane and Womens Hospital

Herston, 4029, Australia

RECRUITING

Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta, T2N 5G2, Canada

RECRUITING

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

RECRUITING

BCCA - Kelowna

Kelowna, British Columbia, V1Y 5L3, Canada

RECRUITING

BCCA - Prince George

Prince George, British Columbia, V2M 7E9, Canada

RECRUITING

BCCA - Vancouver

Vancouver, British Columbia, V5Z 4E6, Canada

RECRUITING

BCCA - Victoria

Victoria, British Columbia, V8R 6V5, Canada

RECRUITING

Royal Victoria Regional Health Centre

Barrie, Ontario, L4M 6M2, Canada

RECRUITING

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, L8V 5C2, Canada

RECRUITING

London Health Sciences Centre Research Inc.

London, Ontario, N6A 5W9, Canada

RECRUITING

Trillium Health Partners - Credit Valley Hospital

Mississauga, Ontario, L5M 2N1, Canada

RECRUITING

Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

University Health Network

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

CHUM-Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2X 3E4, Canada

RECRUITING

The Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

RECRUITING

CIUSSS de l'Estrie - Centre hospitalier

Sherbrooke, Quebec, J1H 5N4, Canada

RECRUITING

Centre Leon Berard

Lyon, Auvergne-Rhône-Alpes, 69008, France

RECRUITING

Institut Gustave-Roussy

Villejuif, FR, 94805, France

RECRUITING

Institut Universitaire du Cancer de Toulouse - IUCT

Toulouse, Occitanie, 31100, France

RECRUITING

Groupe Hospitalier Diaconesses Croix Saint-Simon

Paris, 75012, France

RECRUITING

ASST Spedali Civili Brescia

Brescia, 25123, Italy

RECRUITING

ASST Lecco

Lecco, 23900, Italy

RECRUITING

European Institute of Oncology

Milan, 20141, Italy

RECRUITING

Policlinico Umberto I, Universita Sapienza

Rome, 00161, Italy

RECRUITING

Radiotherapiegroep

Arnhem, Gelderland, 6815AD, Netherlands

RECRUITING

Maastro clinic (Maastricht UMC)

Maastricht, Limburg, 6229ET, Netherlands

RECRUITING

Catharina ziekenhuis

Eindhoven, North Brabant, 5623 EJ, Netherlands

RECRUITING

MC Haaglanden

The Hague, South Holland, 432, Netherlands

RECRUITING

Leiden University Medical Center (LUMC)

Leiden, 2333ZA, Netherlands

RECRUITING

Erasmus Medical Center (EMC)

Rotterdam, Netherlands

RECRUITING

Auckland City Hospital

Auckland, 1023, New Zealand

RECRUITING

Christchurch Hospital

Christchurch, 8140, New Zealand

RECRUITING

Oslo University Hospital

Oslo, Ullernchausseen 70, 0379, Norway

RECRUITING

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Radiotherapy, Adjuvant; Observation

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Radiotherapy; Methods; Investigative Techniques

Study Officials

• Kathy Han

  University Health Network, Princess Margaret Hospital, Toronto ON Canada

  STUDY CHAIR

• Jessica McAlpine

  BCCA-Vancouver Cancer Centre, Vancouver BC Canada

  STUDY CHAIR

Central Study Contacts

Wendy Parulekar

CONTACT

613-533-6430; wparulekar@ctg.queensu.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2022
• First Posted: December 7, 2022
• Study Start: December 19, 2022
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: June 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (4); US (68); CA (15); NZ (2); NL (6); AU (10); NO (1); FR (4)