The Relationship Between Plasma Transforming Growth Factor-beta 1 (TGF-β) and Fractionation in Radiotherapy for Breast Cancer: A Randomized Study
- Compare the ratio between post- and pre-treatment plasma transforming growth
factor-beta 1 (TGF-β) in women with invasive breast cancer undergoing hypofractionated
radiotherapy vs standard-fractionated external-beam radiotherapy.
- Establish longitudinal serum and plasma biorepository for retrospective evaluation of
TGF-β and other biomarkers with special relevance to radiation response.
- Correlate pre-treatment plasma TGF-β levels with clinical fibrosis development.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
- Arm I (hypofractionated radiotherapy): Patients undergo external-beam radiotherapy once
daily 5 days a week for up to 3.5 weeks (16 fractions total).
- Arm II (standard fractionated radiotherapy): Patients undergo radiotherapy as in arm I
at a lower dose for up to 5 weeks (25 fractions total).
After completion of study treatment, patients are followed every 6 months for 2 years and
then annually for 3 years.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
Allocation: Randomized, Primary Purpose: Treatment
Catherine C. Park, MD
University of California, San Francisco
United States: Federal Government
|UCSF Helen Diller Family Comprehensive Cancer Center||San Francisco, California 94115|