NCT00966888

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

Selective Use of Postoperative Radiotherapy AftEr MastectOmy - SUPREMO

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,500 (estimated)
• Sponsor: Medical Research Council · Other Government
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	standard follow-up care	No intervention
RADIATION	radiation therapy	Chest wall radiotherapy

Timeline

• Start date: 2006-01-01
• Primary completion: 2010-06-01
• First posted: 2009-08-27
• Last updated: 2013-08-12

Locations

2 sites across 1 country: United Kingdom