Spots Global Cancer Trial Database for Radiation Therapy After Surgery in Treating Women With Early Stage Breast Cancer
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Trial Identification
Brief Title: Radiation Therapy After Surgery in Treating Women With Early Stage Breast Cancer
Official Title: Standardization of Breast Radiotherapy: Trial B - A Randomized Comparison of Fractionation Regimens After Local Excision or Mastectomy in Women With Early Stage Breast Cancer
Study ID: NCT00005587
Conditions
Interventions
Study Description
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
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
Clatterbridge Centre for Oncology NHS Trust, Merseyside, England, United Kingdom
South Tees Hospitals NHS Trust, Middlesbrough, Cleveland, England, United Kingdom
King Edward VII Hospital, Midhurst, England, United Kingdom
Mount Vernon Hospital, Northwood, England, United Kingdom
Norfolk & Norwich Hospital, Norwich, England, United Kingdom
Nottingham City Hospital NHS Trust, Nottingham, England, United Kingdom
Derriford Hospital, Plymouth, England, United Kingdom
Royal Berkshire Hospital, Reading, England, United Kingdom
Oldchurch Hospital, Romford, England, United Kingdom
Weston Park Hospital, Sheffield, England, United Kingdom
Royal Shrewsbury Hospital, Shrewsbury, England, United Kingdom
North Staffs Royal Infirmary, Stoke-On-Trent, England, United Kingdom
Royal Marsden Hospital, Sutton, England, United Kingdom
Torbay Hospital, Torquay Devon, 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
Ninewells Hospital and Medical School, Dundee, Scotland, United Kingdom
Velindre Hospital, Cardiff, Wales, United Kingdom
Cumberland Infirmary, Carlisle, , United Kingdom
Saint Mary's Hospital, Portsmouth Hants, , United Kingdom
Royal Preston Hospital, Preston, , United Kingdom
Contact Details
Name: John R. Yarnold, MD, FRCR
Affiliation: Royal Marsden NHS Foundation Trust
Role: STUDY_CHAIR
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