Radiation Therapy or Standard Therapy in Treating Women With Stage II Breast Cancer Who Have Undergone Mastectomy
- Conditions
- Breast Cancer
- Registration Number
- NCT00966888
- Lead Sponsor
- Medical Research Council
- Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays or other types of radiation to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether radiation therapy is more effective than observation after mastectomy in treating women with stage II breast cancer.
PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared with standard therapy in treating women with stage II breast cancer who have undergone mastectomy.
- Detailed Description
OBJECTIVES:
* Determine the overall survival of women at intermediate risk for locoregional recurrence of breast cancer treated with ipsilateral chest wall adjuvant radiotherapy after mastectomy.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Beginning 12 weeks after mastectomy or 6 weeks after adjuvant chemotherapy, patients undergo radiotherapy 5 days a week for 3-5 weeks in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients receive standard of care and observation only. After completion of study therapy, patients are followed up twice in the first year, and then annually for up to 10 years.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 3500
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival Acute and late morbidity
- Secondary Outcome Measures
Name Time Method Quality of life Chest wall recurrence Regional recurrence Disease-free survival Metastasis-free survival Cause of death (breast cancer, or intercurrent disease [cardiovascular or non-cardiovascular]) Cost effectiveness
Trial Locations
- Locations (2)
Edinburgh Cancer Centre at Western General Hospital
🇬🇧Edinburgh, Scotland, United Kingdom
Royal Infirmary - Castle
🇬🇧Glasgow, Scotland, United Kingdom
Edinburgh Cancer Centre at Western General Hospital🇬🇧Edinburgh, Scotland, United Kingdom