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

June 8, 2026 updated by: Canadian Cancer Trials Group

A Phase II Study of Tailored Adjuvant Therapy in POLE-Mutated and p53-Wildtype/NSMP Early Stage Endormetrial Cancer (RAINBO BLUE & TAPER)

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

393

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
      • Garran, Australia, ACT 2605
        • Recruiting
        • Canberra Hospital
        • Contact:
          • Andrew Douglas Lee
      • Herston, Australia, 4029
        • Recruiting
        • Royal Brisbane and Womens Hospital
        • Contact:
          • Andrea Garrett
          • Phone Number: 73 646-8111
    • New South Wales
      • Liverpool, New South Wales, Australia, 2170
        • Recruiting
        • South Western Sydney Local Health District
        • Contact:
          • Viet Do
      • St Leonards, New South Wales, Australia, 2065
        • Recruiting
        • Royal North Shore Hospital
        • Contact:
          • Marita Morgia
          • Phone Number: 2 946-3130
      • Waratah, New South Wales, Australia, 2298
        • Recruiting
        • Calvary Mater Newcastle Hospital
        • Contact:
          • Geetha Govindarajulu
      • Westmead, New South Wales, Australia, 2145
        • Recruiting
        • Westmead Hospital
        • Contact:
          • Alison Brand
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • Recruiting
        • Mater Research Institute South Brisbane
        • Contact:
          • Nimithri Cabraal
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Recruiting
        • Monash Medical Centre
        • Contact:
          • Shih-Ern Yao
          • Phone Number: 39 594-6666
      • Frankston, Victoria, Australia, 3199
        • Recruiting
        • Frankston Hospital
        • Contact:
          • Yoland Antill
      • Parkville, Victoria, Australia, 3053
        • Recruiting
        • The Royal Women's Hospital
        • Contact:
          • Orla McNally
          • Phone Number: 2 613 834-5356
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 5G2
        • Recruiting
        • Arthur J.E. Child Comprehensive Cancer Centre
        • Contact:
          • Ruth Fullerton
          • Phone Number: 403 521-3095
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Recruiting
        • Cross Cancer Institute
        • Contact:
          • Fleur Huang
          • Phone Number: 780 432-8516
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 5L3
        • Recruiting
        • BCCA - Kelowna
        • Contact:
          • Hamid Raziee
      • Prince George, British Columbia, Canada, V2M 7E9
        • Recruiting
        • BCCA - Prince George
        • Contact:
          • Allison Ye
          • Phone Number: 250 645-7300
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Recruiting
        • BCCA - Vancouver
        • Contact:
          • Jessica McAlpine
          • Phone Number: 2395 604 877-6000
      • Victoria, British Columbia, Canada, V8R 6V5
        • Recruiting
        • BCCA - Victoria
        • Contact:
          • Caroline Holloway
          • Phone Number: 250 519-5609
    • Ontario
      • Barrie, Ontario, Canada, L4M 6M2
        • Recruiting
        • Royal Victoria Regional Health Centre
        • Contact:
          • Jessica Conway
          • Phone Number: 705 728-9090
      • Hamilton, Ontario, Canada, L8V 5C2
        • Recruiting
        • Juravinski Cancer Centre at Hamilton Health Sciences
        • Contact:
          • Clare Reade
          • Phone Number: 905 389-5688
      • London, Ontario, Canada, N6A 5W9
        • Recruiting
        • London Health Sciences Centre Research Inc.
        • Contact:
          • Lucas Mendez
          • Phone Number: 53169 519 685-8600
      • Mississauga, Ontario, Canada, L5M 2N1
        • Recruiting
        • Trillium Health Partners - Credit Valley Hospital
        • Contact:
          • Katherine Pulman
          • Phone Number: 1841 905 813-1100
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • University Health Network
        • Contact:
          • Kathy Han
          • Phone Number: 2919 416 946-4501
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Odette Cancer Centre
        • Contact:
          • Helen MacKay
          • Phone Number: 416 480-5145
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Recruiting
        • The Jewish General Hospital
        • Contact:
          • Susie K.S. Lau
          • Phone Number: 3114 514 340-8222
      • Montreal, Quebec, Canada, H2X 3E4
        • Recruiting
        • CHUM-Centre Hospitalier de l'Universite de Montreal
        • Contact:
          • Maroie Barkati
          • Phone Number: 514 890-8254
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Recruiting
        • CIUSSS de l'Estrie - Centre hospitalier
        • Contact:
          • Mathieu Viau
  • France
      • Paris, France, 75012
        • Recruiting
        • Groupe Hospitalier Diaconesses Croix Saint-Simon
        • Contact:
          • Frederic Selle
          • Phone Number: 33 144-6437
    • Auvergne-Rhône-Alpes
      • Lyon, Auvergne-Rhône-Alpes, France, 69008
        • Recruiting
        • Centre Leon Berard
        • Contact:
          • Olivia Le Saux
          • Phone Number: 47 878-2828
    • FR
      • Villejuif, FR, France, 94805
        • Recruiting
        • Institut Gustave-Roussy
        • Contact:
          • Alexandra Leary
          • Phone Number: 11 33 142-1142
    • Occitanie
      • Toulouse, Occitanie, France, 31100
        • Recruiting
        • Institut Universitaire du Cancer de Toulouse - IUCT
        • Contact:
          • Laurence Gladieff
  • Italy
      • Brescia, Italy, 25123
        • Recruiting
        • ASST Spedali Civili Brescia
        • Contact:
          • Germana Tognon
      • Lecco, Italy, 23900
        • Recruiting
        • ASST Lecco
        • Contact:
          • Romerai D'Amico
      • Milan, Italy, 20141
        • Recruiting
        • European Institute of Oncology
        • Contact:
          • Ilaria Betella
          • Phone Number: 39 025-7489
      • Rome, Italy, 00161
        • Recruiting
        • Policlinico Umberto I, Universita Sapienza
        • Contact:
          • Federica Tomao
  • Netherlands
      • Leiden, Netherlands, 2333ZA
        • Recruiting
        • Leiden University Medical Center (LUMC)
        • Contact:
          • Stephanie De Boer
      • Rotterdam, Netherlands
        • Recruiting
        • Erasmus Medical Center (EMC)
        • Contact:
          • Henrieke Westerveld
    • Gelderland
      • Arnhem, Gelderland, Netherlands, 6815AD
        • Recruiting
        • Radiotherapiegroep
        • Contact:
          • Dorien Haverkort
          • Phone Number: 318 877-9000
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229ET
        • Recruiting
        • Maastro clinic (Maastricht UMC)
        • Contact:
          • Nienke Kuijsters
          • Phone Number: 31 088-4456
    • North Brabant
      • Eindhoven, North Brabant, Netherlands, 5623 EJ
        • Recruiting
        • Catharina Ziekenhuis
        • Contact:
          • Bastiaan Wortman
          • Phone Number: 40 239-9111
    • South Holland
      • The Hague, South Holland, Netherlands, 432
        • Recruiting
        • MC Haaglanden
        • Contact:
          • Mandy Kiderlen
          • Phone Number: 3 889-7979
  • New Zealand
      • Auckland, New Zealand, 1023
        • Recruiting
        • Auckland City Hospital
        • Contact:
          • Ruth Angell
      • Christchurch, New Zealand, 8140
        • Recruiting
        • Christchurch Hospital
        • Contact:
          • Bryony Simcock
  • Norway
    • Ullernchausseen 70
      • Oslo, Ullernchausseen 70, Norway, 0379
        • Recruiting
        • Oslo University Hospital
        • Contact:
          • Kristina Lindemann
          • Phone Number: 2 293-4983
  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Recruiting
        • Alaska Womens Cancer Care
        • Contact:
          • Melissa Hardesty
          • Phone Number: 907-212-6871
    • Arizona
      • Tucson, Arizona, United States, 85719
        • Recruiting
        • University of Arizona Cancer Center
        • Contact:
          • Marina Miller
    • California
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars-Sinai Medical Center
        • Contact:
          • Andrew Li
          • Phone Number: 310-423-5246
      • Pasadena, California, United States, 91105
        • Recruiting
        • Huntington Memorial Hospital
        • Contact:
          • Andrew Li
          • Phone Number: 310-423-5246
      • Sacramento, California, United States, 95816
        • Recruiting
        • Sutter Medical Center Sacramento
        • Contact:
          • Anna Likhacheva
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • UCHealth University of Colorado Hospital
        • Contact:
          • Bradley Corr
      • Denver, Colorado, United States, 80210
        • Recruiting
        • AdventHealth Porter
        • Contact:
          • Neil Phippen
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami School of Medicine
        • Contact:
          • Joseph Pearson
      • N. Venice, Florida, United States, 34275
        • Recruiting
        • Sarasota Memorial Hospital - Venice
        • Contact:
          • Beverly Long
          • Phone Number: 941-917-2225
      • Sarasota, Florida, United States, 34236
        • Recruiting
        • Florida Cancer Specialists - Sarasota Downtown
        • Contact:
          • Beverly Long
          • Phone Number: 941-917-2225
      • Sarasota, Florida, United States, 34239
        • Recruiting
        • Sarasota Memorial Hospital
        • Contact:
          • Beverly Long
          • Phone Number: 941-917-2225
      • Sarasota, Florida, United States, 34239
        • Recruiting
        • First Physicians Group-Sarasota
        • Contact:
          • Beverly Long
          • Phone Number: 941-917-2225
      • Sarasota, Florida, United States, 34243
        • Recruiting
        • Sarasota Memorial Health Care Centre
        • Contact:
          • Beverly Long
          • Phone Number: 941-917-2225
      • Venice, Florida, United States, 34275
        • Recruiting
        • Florida Cancer Specialists - Venice Pinebrook
        • Contact:
          • Beverly Long
          • Phone Number: 941-917-2225
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Recruiting
        • Grady Health System
        • Contact:
          • Jill Remick
          • Phone Number: 404-778-1900
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • Emory University Hospital Midtown
        • Contact:
          • Jill Remick
          • Phone Number: 404-778-1900
      • Atlanta, Georgia, United States, 30309
        • Recruiting
        • Piedmont Hospital
        • Contact:
          • Leda Gattoc
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University Hospital Winship Cancer Institute
        • Contact:
          • Jill Remick
          • Phone Number: 404-778-1900
      • Atlanta, Georgia, United States, 30342
        • Recruiting
        • Emory Saint Josephs Hospital
        • Contact:
          • Jill Remick
          • Phone Number: 404-778-1900
      • Decatur, Georgia, United States, 30033
        • Recruiting
        • Emory Decatur Hospital
        • Contact:
          • Jill Remick
          • Phone Number: 404-778-1900
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Contact:
          • Dario Roque
          • Phone Number: 312-695-0990
      • Orland Park, Illinois, United States, 60462
        • Recruiting
        • Northwestern Medicine Orland Park
        • Contact:
          • Dario Roque
          • Phone Number: 312-695-0990
      • Warrenville, Illinois, United States, 60555
        • Recruiting
        • Northwestern Medicine Cancer Center Warrenville
        • Contact:
          • Dario Roque
          • Phone Number: 312-695-0990
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Recruiting
        • Ascension Saint Vincent Indianapolis Hospital
        • Contact:
          • Megan Buechel
          • Phone Number: 317-415-6740
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • Norton Hospital Pavilion and Medical Campus
        • Contact:
          • Monica Vetter
          • Phone Number: 502-899-3366
      • Louisville, Kentucky, United States, 40207
        • Recruiting
        • Norton Suburban Hospital and Medical Campus
        • Contact:
          • Monica Vetter
          • Phone Number: 502-899-3366
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • University Medical Center New Orleans
        • Contact:
          • Tara Castellano
          • Phone Number: 504-210-3539
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital Cancer Center
        • Contact:
          • Andrea Russo
          • Phone Number: 617-726-7941
      • Springfield, Massachusetts, United States, 01199
        • Recruiting
        • Baystate Medical Center
        • Contact:
          • Tashanna Myers
          • Phone Number: 413-974-3565
      • Worcester, Massachusetts, United States, 01605
        • Recruiting
        • UMass Memorial Medical Centre
        • Contact:
          • Susan Zweizig
          • Phone Number: 508-856-6265
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Contact:
          • Premal Thaker
          • Phone Number: 314-747-3604
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Recruiting
        • Nebraska Methodist Hospital
        • Contact:
          • Brent Tierney
          • Phone Number: 402-354-5144
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Recruiting
        • Womens Cancer Center of Nevada
        • Contact:
          • Nicola Spirtos
          • Phone Number: 702-851-4672
    • New Jersey
      • Sewell, New Jersey, United States, 08080
        • Recruiting
        • Sidney Kimmel Cancer Center Washington Township
        • Contact:
          • Mitchell Edelson
          • Phone Number: 215-481-4000
    • New York
      • New York, New York, United States, 10011
        • Recruiting
        • Mount Sinai Chelsea
        • Contact:
          • Caitlin Carr
          • Phone Number: 212-824-7309
      • New York, New York, United States, 10029
        • Recruiting
        • Mount Sinai Hospital
        • Contact:
          • Caitlin Carr
          • Phone Number: 212-824-7309
      • Oswego, New York, United States, 13126
        • Recruiting
        • Upstate Cancer Center Radiation Oncology at Oswego
        • Contact:
          • Mary Cunningham
          • Phone Number: 315-634-4112
      • Syracuse, New York, United States, 13210
        • Recruiting
        • Upstate Cancer Center at Hill Radiation Oncology
        • Contact:
          • Mary Cunningham
          • Phone Number: 315-634-4112
      • Syracuse, New York, United States, 13210
        • Recruiting
        • State University of New York
        • Contact:
          • Mary Cunningham
          • Phone Number: 315-634-4112
      • Verona, New York, United States, 13478
        • Recruiting
        • Upstate Cancer Center at Verona
        • Contact:
          • Mary Cunningham
          • Phone Number: 315-634-4112
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • UNC Lineberger Comprehensive Cancer Center
        • Contact:
          • Olivia Lara
          • Phone Number: 877-668-0683
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Medical Center
        • Contact:
          • Angeles Secord
      • Raleigh, North Carolina, United States, 27607
        • Recruiting
        • Duke Womens Cancer Care Raleigh
        • Contact:
          • Angeles Secord
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Recruiting
        • UHHS-Chagrin Highlands Medical Center
        • Contact:
          • Sarah Lynam
          • Phone Number: 216-844-3954
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • Case Western Reserve University
        • Contact:
          • Sarah Lynam
          • Phone Number: 216-844-3954
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University Comprehensive
        • Contact:
          • Casey Cosgrove
      • Mentor, Ohio, United States, 44060
        • Recruiting
        • UH Seidman Cancer Center
        • Contact:
          • Sarah Lynam
          • Phone Number: 216-844-3954
      • Parma, Ohio, United States, 44129
        • Recruiting
        • University Hospitals Parma Medical Center
        • Contact:
          • Sarah Lynam
          • Phone Number: 216-844-3954
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma Health Sciences Center
        • Contact:
          • Christina Washington
          • Phone Number: 405-271-8777
    • Oregon
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Providence Saint Vincent Medical Center
        • Contact:
          • Alison Conlin
          • Phone Number: 503-215-6259
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence Portland Medical Centre
        • Contact:
          • Alison Conlin
          • Phone Number: 503-215-6259
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Recruiting
        • Penn State Milton S Hershey Medical Center
        • Contact:
          • Shaina Bruce
          • Phone Number: 717-531-3779
      • Paoli, Pennsylvania, United States, 19301
        • Recruiting
        • Paoli Memorial Hospital
        • Contact:
          • Paul Gilman
          • Phone Number: 484-476-2649
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University
        • Contact:
          • Mitchell Edelson
          • Phone Number: 215-481-4000
      • Willow Grove, Pennsylvania, United States, 19090
        • Recruiting
        • Asplundh Cancer Pavilion
        • Contact:
          • Mitchell Edelson
          • Phone Number: 215-481-4000
      • Wynnewood, Pennsylvania, United States, 19096
        • Recruiting
        • Lankenau Medical Center
        • Contact:
          • Paul Gilman
          • Phone Number: 484-476-2649
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Recruiting
        • Women and Infants Hospital
        • Contact:
          • Matthew Oliver
          • Phone Number: 48181 401-274-1122
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • M.D. Anderson Cancer Center
        • Contact:
          • Ann Klopp
          • Phone Number: 713-563-2444
    • Utah
      • Farmington, Utah, United States, 84025
        • Recruiting
        • Farmington Health Centre
        • Contact:
          • Cristina DeCesaris
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • Huntsman Cancer Institute University of Utah
        • Contact:
          • Cristina DeCesaris
      • Salt Lake City, Utah, United States, 84106
        • Recruiting
        • University of Utah Sugarhouse Health Centre
        • Contact:
          • Cristina DeCesaris
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Recruiting
        • University of Vermont Medical Center
        • Contact:
          • Puyao Li
          • Phone Number: 802-656-8990
      • Burlington, Vermont, United States, 05405
        • Recruiting
        • University of Vermont and State Agricultural College
        • Contact:
          • Puyao Li
          • Phone Number: 802-656-8990
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia Cancer Center
        • Contact:
          • Kara Romano
          • Phone Number: 434-924-5191
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • Virginia Commonwealth University
        • Contact:
          • Emma Fields
    • Washington
      • Seattle, Washington, United States, 98122
        • Recruiting
        • Swedish Medical Center First Hill
        • Contact:
          • Charles Drescher
          • Phone Number: 206-991-2000
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54301
        • Recruiting
        • Saint Vincent Hospital Cancer Center Green Bay
        • Contact:
          • Matthew Ryan
          • Phone Number: 920-884-3135
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Contact:
          • William Bradley
          • Phone Number: 414-805-6600

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sub-study A: RAINBO BLUE Cohort A1
Observation
Other: Observation
Observation
Experimental: Sub-Study B: TAPER
Observation or Vaginal Brachytherapy
Other: Observation
Observation
Radiation: Vaginal brachytherapy
Vaginal brachytherapy should be delivered using a vaginal cylinder, or alternatively ovoids
Experimental: Sub-Study A: RAINBO BLUE Cohort A2
Observation or Adjuvant Radiotherapy
Other: Observation
Observation
Radiation: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Estimate the rate of isolated vaginal recurrence at 3 years
Time Frame: 3 years
3 years
Estimate the rate of para-aortic recurrence at 3 years
Time Frame: 3 years
3 years
Estimate the rate of distant metastasis at 3 years
Time Frame: 3 years
3 years
Estimate recurrence-free survival
Time Frame: 9 years
9 years
Estimate endometrial cancer-specific survival
Time Frame: 9 years
9 years
Estimate overall survival
Time Frame: 9 years
9 years
Describe the impact of molecular classification on fear of recurrence by Fear of Recurrence Inventory
Time Frame: 9 years
9 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Canadian Cancer Trials Group

Collaborators

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

Investigators

  • Study Chair: Kathy Han, University Health Network, Princess Margaret Hospital, Toronto ON Canada
  • Study Chair: Jessica McAlpine, BCCA-Vancouver Cancer Centre, Vancouver BC Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2022

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

June 30, 2029

Study Registration Dates

First Submitted

November 29, 2022

First Submitted That Met QC Criteria

November 29, 2022

First Posted (Actual)

December 7, 2022

Study Record Updates

Last Update Posted (Actual)

June 9, 2026

Last Update Submitted That Met QC Criteria

June 8, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EN10 (CCTG)
  • NRG-GY032 (Other Identifier: NRG)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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