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.

Study Timeline

• Study Start: 2006-01
• Status Verified: 2009-08
• Study First Submitted: 2009-08-26
• Study First Submitted QC: 2009-08-26
• Study First Posted: 2009-08-27
• Primary Completion: 2010-06
• Last Update Submitted: 2013-08-09
• Last Update Posted: 2013-08-12

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

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