Radiation Therapy After Surgery in Treating Women With Early Stage Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT00005587
- Lead Sponsor
- Medical Research Council
- 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.
Quality of life is assessed at baseline and then at 6, 12, 24, and 60 months.
Patients are followed annually for up to 20 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 1840 patients (920 per arm) will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (32)
Royal Sussex County Hospital
🇬🇧Brighton, England, United Kingdom
Addenbrooke's NHS Trust
🇬🇧Cambridge, England, United Kingdom
Cheltenham General Hospital
🇬🇧Cheltenham, England, United Kingdom
Royal Devon and Exeter Hospital
🇬🇧Exeter, England, United Kingdom
Royal Surrey County Hospital
🇬🇧Guildford, England, United Kingdom
Ipswich Hospital NHS Trust
🇬🇧Ipswich, England, United Kingdom
University Hospitals of Leicester
🇬🇧Leicester, England, United Kingdom
Guy's and St. Thomas' Hospitals Trust
🇬🇧London, England, United Kingdom
Maidstone Hospital
🇬🇧Maidstone, England, United Kingdom
Christie Hospital N.H.S. Trust
🇬🇧Manchester, England, United Kingdom
Scroll for more (22 remaining)Royal Sussex County Hospital🇬🇧Brighton, England, United Kingdom