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Study of Radiation Fractionation on Patient Outcomes After Breast REConstruction (FABREC) for Invasive Breast Carcinoma
Sponsor: Dana-Farber Cancer Institute
Summary
This study is a randomized trial of hypofractionation (short-course) radiation therapy versus conventional radiation therapy in women who have undergone mastectomy and immediate breast reconstruction. The investigators will assess cosmetic and reconstruction outcomes, lymphedema, cancer status, side effects, and oncologic outcomes.
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2018-04-01
Completion Date
2030-04-01
Last Updated
2024-11-01
Healthy Volunteers
No
Conditions
Interventions
Radiation Therapy
For the conventional fractionation arm: Each fraction will consist of 200 cGy per day. Total dose = 5000 cGy to the chest wall and 4600-5000 cGy to the lymph nodes. For the hypofractionation arm: Each fraction consists of 266 cGy per day. Total dose = 4256 cGy to the chest wall and 3990 cGy to the lymph nodes.
Locations (15)
University of California, San Francisco
San Francisco, California, United States
Stanford University Medical Center
Stanford, California, United States
Vail Health
Edwards, Colorado, United States
Yale Cancer Center
New Haven, Connecticut, United States
Johns Hopkins Medicine
Washington D.C., District of Columbia, United States
Eastern Maine Medical Center
Brewer, Maine, United States
Maine Medical Center
Scarborough, Maine, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Massachusetts General Hospital/North Shore Center for Outpatient Care
Danvers, Massachusetts, United States
Dana-Farber/Brigham and Women's Cancer Center (DF/BWCC) at Milford Regional Medical Center
Milford, Massachusetts, United States
Dana-Farber/Brigham and Women's Cancer Center in clinical affiliation with South Shore Hospital
South Weymouth, Massachusetts, United States
Lifespan/Rhode Island Hospital
Providence, Rhode Island, United States
University of Washington
Seattle, Washington, United States