Radiation Therapy in Treating Women With Localized Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Radiation: Radiation therapy
- Registration Number
- NCT00107497
- Lead Sponsor
- Institute of Cancer Research, United Kingdom
- Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in different ways and giving it after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This randomized clinical trial is studying radiation therapy to see how well it works in treating women with localized breast cancer.
- Detailed Description
OBJECTIVES:
* Compare late normal tissue effects of standard vs 2 different dose levels of hypofractionated adjuvant whole breast radiotherapy, in terms of changes in photographic breast appearance, in women with localized breast cancer who are at average or low risk of recurrence.
* Compare tumor control in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 3 treatment arms.
* Arm I (control): Patients undergo standard radiotherapy 5 days a week for 5 weeks.
* Arm II: Patients undergo hypofractional radiotherapy once a week for 5 weeks.
* Arm III: Patients undergo hypofractional radiotherapy (at a lower dose than arm II) once a week for 5 weeks.
After completion of study treatment, patients are followed annually for 5-10 years.
PROJECTED ACCRUAL: A total of 900 patients (300 per treatment arm) will be accrued for this study within 12 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 917
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Test group 2 Radiation therapy 28.5Gy in 5 fractions of radiation therapy over 5 weeks Control Radiation therapy 50Gy in 25 fractions of radiation therapy over 5 weeks Test group 1 Radiation therapy 30Gy in 5 fractions of radiation therapy over 5 weeks
- Primary Outcome Measures
Name Time Method Change in photographic breast appearance 2 years post randomisation Change in photographic breast appearance at 2 years post randomisation compared to a baseline pre-surgical photograph
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (19)
Southend University Hospital NHS Foundation Trust
🇬🇧Westcliff-On-Sea, England, United Kingdom
Royal Shrewsbury Hospital
🇬🇧Shrewsbury, England, United Kingdom
University Hospital of North Staffordshire
🇬🇧Stoke-On-Trent, England, United Kingdom
Royal Marsden NHS Foundation Trust - Surrey
🇬🇧Sutton, England, United Kingdom
Torbay Hospital
🇬🇧Torquay Devon, England, United Kingdom
Worthing Hospital
🇬🇧Worthing, England, United Kingdom
Velindre Cancer Center at Velindre Hospital
🇬🇧Cardiff, Wales, United Kingdom
Sussex Cancer Centre at Royal Sussex County Hospital
🇬🇧Brighton, England, United Kingdom
Cumberland Infirmary
🇬🇧Carlisle, England, United Kingdom
Royal Devon and Exeter Hospital
🇬🇧Exeter, England, United Kingdom
Cheltenham General Hospital
🇬🇧Cheltenham, England, United Kingdom
Ipswich Hospital NHS Trust
🇬🇧Ipswich, England, United Kingdom
Clatterbridge Centre for Oncology NHS Trust
🇬🇧Merseyside, England, United Kingdom
Christie Hospital NHS Trust
🇬🇧Manchester, England, United Kingdom
Berkshire Cancer Centre at Royal Berkshire Hospital
🇬🇧Reading, England, United Kingdom
Royal Cornwall Hospital
🇬🇧Truro, Cornwall, England, United Kingdom
Worcester Royal Hospital
🇬🇧Worcester, England, United Kingdom
Halton Hospital - North Cheshire Hospitals NHS Trust
🇬🇧Cheshire, United Kingdom
Hereford Hospitals NHS Trust
🇬🇧Hereford, United Kingdom