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Radiation Therapy or Standard Therapy in Treating Women With Stage II Breast Cancer Who Have Undergone Mastectomy

Phase 3
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
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Overall survival
Acute and late morbidity
Secondary Outcome Measures
NameTimeMethod
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

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