Adjuvant Therapy in POLE-Mutated and p53-Wildtype/NSMP Early Stage Endometrial Cancer RAINBO BLUE & TAPER
Start Date
12/19/2022
Completion Date
6/30/2029
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
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Vaginal brachytherapy
Adjuvant radiotherapy (EBRT +/- brachytherapy)
Observation
Conditions
Locations
Alaska Womens Cancer Care
Anchorage, Alaska 99508
United States
University of Arizona Cancer Center
Tucson, Arizona 85719
United States
Cedars-Sinai Medical Center
Los Angeles, California 90048
United States
Huntington Memorial Hospital
Pasadena, California 91105
United States
Sutter Medical Center Sacramento
Sacramento, California 95816
United States
UCHealth University of Colorado Hospital
Aurora, Colorado 80045
United States
AdventHealth Porter
Denver, Colorado 80210
United States
University of Florida
Gainesville, Florida 32610-0277
United States
University of Miami School of Medicine
Miami, Florida 33136
United States
Sarasota Memorial Hospital - Venice
N. Venice, Florida 34275
United States
Florida Cancer Specialists - Sarasota Downtown
Sarasota, Florida 34236
United States
First Physicians Group-Sarasota
Sarasota, Florida 34239
United States
Sarasota Memorial Hospital
Sarasota, Florida 34239
United States
Sarasota Memorial Health Care Centre
Sarasota, Florida 34243
United States
Florida Cancer Specialists - Venice Pinebrook
Venice, Florida 34275
United States
Grady Health System
Atlanta, Georgia 30303
United States
Emory University Hospital Midtown
Atlanta, Georgia 30308
United States
Piedmont Hospital
Atlanta, Georgia 30309
United States
Emory University Hospital Winship Cancer Institute
Atlanta, Georgia 30322
United States
Emory Saint Josephs Hospital
Atlanta, Georgia 30342
United States
Emory Decatur Hospital
Decatur, Georgia 30033
United States
Northwestern University
Chicago, Illinois 60611
United States
Northwestern Medicine Orland Park
Orland Park, Illinois 60462
United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois 60555
United States
Ascension Saint Vincent Indianapolis Hospital
Indianapolis, Indiana 46260
United States
Norton Hospital Pavilion and Medical Campus
Louisville, Kentucky 40202
United States
Norton Suburban Hospital and Medical Campus
Louisville, Kentucky 40207
United States
University Medical Center New Orleans
New Orleans, Louisiana 70112
United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts 02114
United States
Baystate Medical Center
Springfield, Massachusetts 01199
United States
UMass Memorial Medical Centre
Worcester, Massachusetts 01605
United States
Washington University School of Medicine
St Louis, Missouri 63110
United States
Nebraska Methodist Hospital
Omaha, Nebraska 68114
United States
Womens Cancer Center of Nevada
Las Vegas, Nevada 89106
United States
Sidney Kimmel Cancer Center Washington Township
Sewell, New Jersey 08080
United States
Roswell Park Cancer Institute
Buffalo, New York 14263
United States
Mount Sinai Chelsea
New York, New York 10011
United States
Mount Sinai Hospital
New York, New York 10029
United States
Upstate Cancer Center Radiation Oncology at Oswego
Oswego, New York 13126
United States
State University of New York
Syracuse, New York 13210
United States
Upstate Cancer Center at Hill Radiation Oncology
Syracuse, New York 13210
United States
Upstate Cancer Center at Verona
Verona, New York 13478
United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina 27599
United States
Duke University Medical Center
Durham, North Carolina 27710
United States
Duke Womens Cancer Care Raleigh
Raleigh, North Carolina 27607
United States
UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio 44122
United States
Geauga Hospital
Chardon, Ohio 44024
United States
Case Western Reserve University
Cleveland, Ohio 44106
United States
Ohio State University Comprehensive
Columbus, Ohio 43210
United States
UH Seidman Cancer Center
Mentor, Ohio 44060
United States
University Hospitals Parma Medical Center
Parma, Ohio 44129
United States
UH Seidman Cancer Center
Westlake, Ohio 44145
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
United States
Providence Portland Medical Centre
Portland, Oregon 97213
United States
Providence Saint Vincent Medical Center
Portland, Oregon 97225
United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania 17033
United States
Paoli Memorial Hospital
Paoli, Pennsylvania 19301
United States
Thomas Jefferson University
Philadelphia, Pennsylvania 19107
United States
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania 19090
United States
Lankenau Medical Center
Wynnewood, Pennsylvania 19096
United States
Women and Infants Hospital
Providence, Rhode Island 02905
United States
M.D. Anderson Cancer Center
Houston, Texas 77030
United States
Farmington Health Centre
Farmington, Utah 84025
United States
University of Utah Sugarhouse Health Centre
Salt Lake City, Utah 84106
United States
Huntsman Cancer Institute University of Utah
Salt Lake City, Utah 84112
United States
University of Vermont Medical Center
Burlington, Vermont 05401
United States
University of Vermont and State Agricultural College
Burlington, Vermont 05405
United States
University of Virginia Cancer Center
Charlottesville, Virginia 22908
United States
Virginia Commonwealth University
Richmond, Virginia 23298
United States
Swedish Medical Center First Hill
Seattle, Washington 98122
United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin 54301
United States
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United States
South Western Sydney Local Health District
Liverpool, New South Wales 2170
Australia
Royal North Shore Hospital
St Leonards, New South Wales 2065
Australia
Calvary Mater Newcastle Hospital
Waratah, New South Wales 2298
Australia
Westmead Hospital
Westmead, New South Wales 2145
Australia
Mater Research Institute South Brisbane
South Brisbane, Queensland 4101
Australia
Monash Medical Centre
Clayton, Victoria 3168
Australia
Frankston Hospital
Frankston, Victoria 3199
Australia
The Royal Women's Hospital
Parkville, Victoria 3053
Australia
Canberra Hospital
Garran, ACT 2605
Australia
Royal Brisbane and Womens Hospital
Herston, 4029
Australia
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta T2N 5G2
Canada
Cross Cancer Institute
Edmonton, Alberta T6G 1Z2
Canada
BCCA - Kelowna
Kelowna, British Columbia V1Y 5L3
Canada
BCCA - Prince George
Prince George, British Columbia V2M 7E9
Canada
BCCA - Vancouver
Vancouver, British Columbia V5Z 4E6
Canada
BCCA - Victoria
Victoria, British Columbia V8R 6V5
Canada
Royal Victoria Regional Health Centre
Barrie, Ontario L4M 6M2
Canada
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario L8V 5C2
Canada
London Health Sciences Centre Research Inc.
London, Ontario N6A 5W9
Canada
Trillium Health Partners - Credit Valley Hospital
Mississauga, Ontario L5M 2N1
Canada
Odette Cancer Centre
Toronto, Ontario M4N 3M5
Canada
University Health Network
Toronto, Ontario M5G 2M9
Canada
CHUM-Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec H2X 3E4
Canada
The Jewish General Hospital
Montreal, Quebec H3T 1E2
Canada
CIUSSS de l'Estrie - Centre hospitalier
Sherbrooke, Quebec J1H 5N4
Canada
Centre Leon Berard
Lyon, Auvergne-Rhône-Alpes 69008
France
Institut Gustave-Roussy
Villejuif, FR 94805
France
Institut Universitaire du Cancer de Toulouse - IUCT
Toulouse, Occitanie 31100
France
Groupe Hospitalier Diaconesses Croix Saint-Simon
Paris, 75012
France
ASST Spedali Civili Brescia
Brescia, 25123
Italy
ASST Lecco
Lecco, 23900
Italy
European Institute of Oncology
Milan, 20141
Italy
Policlinico Umberto I, Universita Sapienza
Rome, 00161
Italy
Radiotherapiegroep
Arnhem, Gelderland 6815AD
Netherlands
Maastro clinic (Maastricht UMC)
Maastricht, Limburg 6229ET
Netherlands
Catharina ziekenhuis
Eindhoven, North Brabant 5623 EJ
Netherlands
MC Haaglanden
The Hague, South Holland 432
Netherlands
Leiden University Medical Center (LUMC)
Leiden, 2333ZA
Netherlands
Erasmus Medical Center (EMC)
Rotterdam,
Netherlands
Auckland City Hospital
Auckland, 1023
New Zealand
Christchurch Hospital
Christchurch, 8140
New Zealand
Oslo University Hospital
Oslo, Ullernchausseen 70 0379
Norway