Phase II Trial of Single Fraction Radiation Therapy (SFRT) at Roswell Park Cancer Institute for Select Patients With Early Stage Breast Cancer
I. For select patients with early stage breast cancer undergoing wide local excision
followed by single fraction radiation therapy (SFRT), we will evaluate rates of
observer-rated toxicity, cosmetic outcomes and patient satisfaction, objective measures of
toxicity and quality of life as well as delivery of intended dose.
I. Locoregional control reported at five years.
Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once
negative margins are obtained.
After completion of study treatment, patients are followed at 1 week, 1 month, 3 months, and
then every 6 months for 2 years.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Toxicity as assessed by National Cancer Institute (NCI) Common Toxicity Criteria (CTC) v 3.0
Acute toxicities will be graded using the NCI CTC version 3.0.
1 week post treatment
Roswell Park Cancer Institute
United States: Institutional Review Board
|Roswell Park Cancer Institute||Buffalo, New York 14263|