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ACTIVE NOT RECRUITING
NCT03422003
NA

Study of Radiation Fractionation on Patient Outcomes After Breast REConstruction (FABREC) for Invasive Breast Carcinoma

Sponsor: Dana-Farber Cancer Institute

View on ClinicalTrials.gov

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

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