Radiation Therapy After Surgery in Treating Women With Early Stage Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT00005588
- 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 different 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 3 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 fortnight (i.e., Monday/Wednesday/Friday/Tuesday/Thursday/Monday, etc.) for 13 fractions over 5 weeks for a total dose of 41.6 Gy.
* Arm III: Patients receive radiotherapy as in arm II for a total dose of 39 Gy. A breast boost is recommended in all 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.
PROJECTED ACCRUAL: A total of 2,010 patients (670 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)
Christie Hospital N.H.S. Trust
🇬🇧Manchester, England, United Kingdom
Cheltenham General Hospital
🇬🇧Cheltenham, England, United Kingdom
South Tees Hospitals NHS Trust
🇬🇧Middlesbrough, Cleveland, England, United Kingdom
University Hospitals of Leicester
🇬🇧Leicester, England, United Kingdom
Maidstone Hospital
🇬🇧Maidstone, England, United Kingdom
Royal Berkshire Hospital
🇬🇧Reading, England, United Kingdom
Mount Vernon Hospital
🇬🇧Northwood, England, United Kingdom
Nottingham City Hospital NHS Trust
🇬🇧Nottingham, England, United Kingdom
Weston Park Hospital
🇬🇧Sheffield, England, United Kingdom
North Staffs Royal Infirmary
🇬🇧Stoke-On-Trent, England, United Kingdom
Royal Shrewsbury Hospital
🇬🇧Shrewsbury, England, United Kingdom
Southend NHS Trust Hospital
🇬🇧Westcliff-On-Sea, England, United Kingdom
New Cross Hospital
🇬🇧Wolverhampton, England, United Kingdom
Belfast City Hospital Trust Incorporating Belvoir Park Hospital
🇬🇧Belfast, Northern Ireland, United Kingdom
Royal Sussex County Hospital
🇬🇧Brighton, England, United Kingdom
Guy's and St. Thomas' Hospitals Trust
🇬🇧London, England, United Kingdom
Ipswich Hospital NHS Trust
🇬🇧Ipswich, England, United Kingdom
Ninewells Hospital and Medical School
🇬🇧Dundee, Scotland, United Kingdom
Velindre Hospital
🇬🇧Cardiff, Wales, United Kingdom
Royal Preston Hospital
🇬🇧Preston, United Kingdom
Cumberland Infirmary
🇬🇧Carlisle, United Kingdom
Saint Mary's Hospital
🇬🇧Portsmouth Hants, United Kingdom
Royal Devon and Exeter Hospital
🇬🇧Exeter, England, United Kingdom
Royal Surrey County Hospital
🇬🇧Guildford, England, United Kingdom
Addenbrooke's NHS Trust
🇬🇧Cambridge, England, United Kingdom
Clatterbridge Centre for Oncology NHS Trust
🇬🇧Merseyside, England, United Kingdom
King Edward VII Hospital
🇬🇧Midhurst, England, United Kingdom
Norfolk & Norwich Hospital
🇬🇧Norwich, England, United Kingdom
Derriford Hospital
🇬🇧Plymouth, England, United Kingdom
Oldchurch Hospital
🇬🇧Romford, England, United Kingdom
Royal Marsden Hospital
🇬🇧Sutton, England, United Kingdom
Torbay Hospital
🇬🇧Torquay Devon, England, United Kingdom