Standardization of Breast Radiotherapy: Trial B - A Randomized Comparison of Fractionation Regimens After Local Excision or Mastectomy in Women With Early Stage Breast Cancer
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Medical Research Council
- Locations
- 32
Study Overview
Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of radiation therapy is more effective following surgery for breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of radiation therapy following surgery in treating women who have early stage breast cancer.
Detailed Description
OBJECTIVES:
- Determine the benefits of radiotherapy schedules using fraction sizes larger than 2.0 Gy in terms of normal tissue responses, local-regional tumor control, quality of life, and economic consequences in women prescribed postoperative radiotherapy for early stage breast cancer.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, type of surgery (mastectomy vs local excision), and breast boost (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive radiotherapy 5 times a week for 5 weeks for a total dose of 50 Gy.
- Arm II: Patients receive radiotherapy 5 times a week for 3 weeks for a total dose of 40 Gy.
A breast boost is recommended in both arms for patients with microscopic evidence of invasive or in situ cancer at, or within 1 mm of, a resection margin. These patients receive radiotherapy for 5 fractions in 1 week for a total boost dose of 10 Gy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed invasive unilateral breast cancer
- •T1-3, N0-1, M0 at presentation
- •Complete macroscopic excision of tumor by breast conserving surgery or mastectomy
- •No immediate breast reconstruction
- •No requirement for axillary radiotherapy after greater than a Level 1 axillary dissection or after greater than 10 lymph nodes have been removed
- •Not enrolled on SECRAB or OSCAR trials
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Menopausal status:
- •Not specified
- •Performance status:
- •Not specified
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •Not specified
- •Not specified
- •PRIOR CONCURRENT THERAPY:
- •Prior neoadjuvant, or primary medical, therapy is allowed provided subsequent surgery confirms complete macroscopic excision of residual primary tumor
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •At least 2 weeks since prior cytotoxic agents
- •No concurrent chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •See Disease Characteristics
- •See Disease Characteristics
Exclusion Criteria
- Not provided