A Phase II Study of Tailored Adjuvant Therapy in POLE-Mutated and p53-Wildtype/NSMP Early Stage Endormetrial Cancer (RAINBO BLUE & TAPER)
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.
Arms & interventions
- RadiationVaginal brachytherapy
Vaginal brachytherapy should be delivered using a vaginal cylinder, or alternatively ovoids
- RadiationAdjuvant 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.
- OtherObservation
Observation
Outcome measures
Primary
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
Secondary
Estimate the rate of isolated vaginal recurrence at 3 years
Time frame: 3 years
Estimate the rate of para-aortic recurrence at 3 years
Time frame: 3 years
Estimate the rate of distant metastasis at 3 years
Time frame: 3 years
Estimate recurrence-free survival
Time frame: 9 years
Estimate endometrial cancer-specific survival
Time frame: 9 years
Estimate overall survival
Time frame: 9 years
Describe the impact of molecular classification on fear of recurrence by Fear of Recurrence Inventory
Time frame: 9 years
Eligibility criteria
Study locations (68)
Alaska Womens Cancer Care
Anchorage, Alaska, 99508
University of Arizona Cancer Center
Tucson, Arizona, 85719
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Huntington Memorial Hospital
Pasadena, California, 91105
Sutter Medical Center Sacramento
Sacramento, California, 95816
UCHealth University of Colorado Hospital
Aurora, Colorado, 80045
AdventHealth Porter
Denver, Colorado, 80210
University of Miami School of Medicine
Miami, Florida, 33136
Sarasota Memorial Hospital - Venice
N. Venice, Florida, 34275
Florida Cancer Specialists - Sarasota Downtown
Sarasota, Florida, 34236
First Physicians Group-Sarasota
Sarasota, Florida, 34239
Sarasota Memorial Hospital
Sarasota, Florida, 34239
Sarasota Memorial Health Care Centre
Sarasota, Florida, 34243
Florida Cancer Specialists - Venice Pinebrook
Venice, Florida, 34275
Grady Health System
Atlanta, Georgia, 30303
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Piedmont Hospital
Atlanta, Georgia, 30309
Emory University Hospital Winship Cancer Institute
Atlanta, Georgia, 30322
Emory Saint Josephs Hospital
Atlanta, Georgia, 30342
Emory Decatur Hospital
Decatur, Georgia, 30033
Northwestern University
Chicago, Illinois, 60611
Northwestern Medicine Orland Park
Orland Park, Illinois, 60462
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555
Ascension Saint Vincent Indianapolis Hospital
Indianapolis, Indiana, 46260
Norton Hospital Pavilion and Medical Campus
Louisville, Kentucky, 40202
Norton Suburban Hospital and Medical Campus
Louisville, Kentucky, 40207
University Medical Center New Orleans
New Orleans, Louisiana, 70112
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Baystate Medical Center
Springfield, Massachusetts, 01199
UMass Memorial Medical Centre
Worcester, Massachusetts, 01605
Washington University School of Medicine
St Louis, Missouri, 63110
Nebraska Methodist Hospital
Omaha, Nebraska, 68114
Womens Cancer Center of Nevada
Las Vegas, Nevada, 89106
Sidney Kimmel Cancer Center Washington Township
Sewell, New Jersey, 08080
Mount Sinai Chelsea
New York, New York, 10011
Mount Sinai Hospital
New York, New York, 10029
Upstate Cancer Center Radiation Oncology at Oswego
Oswego, New York, 13126
State University of New York
Syracuse, New York, 13210
Upstate Cancer Center at Hill Radiation Oncology
Syracuse, New York, 13210
Upstate Cancer Center at Verona
Verona, New York, 13478
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Duke University Medical Center
Durham, North Carolina, 27710
Duke Womens Cancer Care Raleigh
Raleigh, North Carolina, 27607
UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio, 44122
Case Western Reserve University
Cleveland, Ohio, 44106
Ohio State University Comprehensive
Columbus, Ohio, 43210
UH Seidman Cancer Center
Mentor, Ohio, 44060
University Hospitals Parma Medical Center
Parma, Ohio, 44129
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Providence Portland Medical Centre
Portland, Oregon, 97213
Providence Saint Vincent Medical Center
Portland, Oregon, 97225
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033
Paoli Memorial Hospital
Paoli, Pennsylvania, 19301
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania, 19090
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096
Women and Infants Hospital
Providence, Rhode Island, 02905
M.D. Anderson Cancer Center
Houston, Texas, 77030
Farmington Health Centre
Farmington, Utah, 84025
University of Utah Sugarhouse Health Centre
Salt Lake City, Utah, 84106
Huntsman Cancer Institute University of Utah
Salt Lake City, Utah, 84112
University of Vermont Medical Center
Burlington, Vermont, 05401
University of Vermont and State Agricultural College
Burlington, Vermont, 05405
University of Virginia Cancer Center
Charlottesville, Virginia, 22908
Virginia Commonwealth University
Richmond, Virginia, 23298
Swedish Medical Center First Hill
Seattle, Washington, 98122
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226