Prospective Randomised Clinical Trial Testing 5.7 Gy and 6.0 Gy Fractions of Whole Breast Radiotherapy in Terms of Late Normal Tissue Responses and Tumour Control - FAST
- Compare late normal tissue effects of standard vs 2 different dose levels of
hypofractionated adjuvant whole breast radiotherapy, in terms of changes in
photographic breast appearance, in women with localized breast cancer who are at
average or low risk of recurrence.
- Compare tumor control in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center. Patients are randomized to 1 of 3 treatment arms.
- Arm I (control): Patients undergo standard radiotherapy 5 days a week for 5 weeks.
- Arm II: Patients undergo hypofractional radiotherapy once a week for 5 weeks.
- Arm III: Patients undergo hypofractional radiotherapy (at a lower dose than arm II)
once a week for 5 weeks.
After completion of study treatment, patients are followed annually for 5-10 years.
PROJECTED ACCRUAL: A total of 900 patients (300 per treatment arm) will be accrued for this
study within 12 months.
Allocation: Randomized, Primary Purpose: Treatment
John R. Yarnold, MD, FRCR
Royal Marsden NHS Foundation Trust
United States: Federal Government