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Adjuvant Therapy in POLE-Mutated and p53-Wildtype/NSMP Early Stage Endometrial Cancer RAINBO BLUE & TAPER
Sponsor: Canadian Cancer Trials Group
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
Official title: A Phase II Study of Tailored Adjuvant Therapy in POLE-Mutated and p53-Wildtype/NSMP Early Stage Endormetrial Cancer (RAINBO BLUE & TAPER)
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
393
Start Date
2022-12-19
Completion Date
2029-06-30
Last Updated
2026-03-10
Healthy Volunteers
No
Conditions
Interventions
Vaginal brachytherapy
Vaginal brachytherapy should be delivered using a vaginal cylinder, or alternatively ovoids
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.
Observation
Observation
Locations (100)
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
University of Miami School of Medicine
Miami, Florida, United States
Sarasota Memorial Hospital - Venice
N. Venice, 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
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
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
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
Case Western Reserve University
Cleveland, Ohio, United States
Ohio State University Comprehensive
Columbus, 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
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Asplundh Cancer Pavilion
Willow Grove, 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
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
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
Institut Universitaire du Cancer de Toulouse - IUCT
Toulouse, Occitanie, France
Groupe Hospitalier Diaconesses Croix Saint-Simon
Paris, France
ASST Spedali Civili Brescia
Brescia, Italy
European Institute of Oncology
Milan, 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