Randomized Trial Testing Dose Escalated Intensity Modulated Radiotherapy for Women Treated by Breast Conservation Surgery and Appropriate Systemic Therapy for Early Breast Cancer
- To test dose-escalated intensity-modulated radiotherapy after breast conservation
surgery in women with early breast cancer who are at higher than average risk for local
OUTLINE: This is a multicenter study. Patients are stratified according to center. Patients
are randomized to 1 of 3 treatment arms.
- Arm I (control): Patients undergo sequential boost dose intensity-modulated
radiotherapy (IMRT) 5 days a week for 4.6 weeks (23 fractions; 56 Gy).
- Arm II: Patients undergo concurrent boost dose IMRT 5 days a week for 3 weeks (15
fractions; 48 Gy).
- Arm III: Patients undergo concurrent boost dose IMRT 5 days a week for 3 weeks (15
fractions; 53 Gy).
Quality-of-life questionnaires are administered at baseline, 6 months, and at 1, 3, and 5
years. Photograph assessments of the breasts are taken at baseline and at 3 and 5 years.
Blood samples are collected at baseline and periodically thereafter. Tissue samples are also
collected from primary tumor, including new primary tumor in either breast, and recurrent
After completion of study treatment, patients are followed annually for 10 years.
Allocation: Randomized, Primary Purpose: Treatment
Palpable induration inside the boost volume of the irradiated breast
John R. Yarnold, MD, FRCR
Royal Marsden NHS Foundation Trust