NCT00005983

S9927 Radiation Therapy After Surgery, Chemotherapy, and/or Hormone Therapy in Stage II Breast Cancer

Randomized Trial of Post-Mastectomy Radiotherapy in Stage II Breast Cancer in Women With One to Three Positive Axillary Nodes Phase III

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether mastectomy, chemotherapy, and/or hormone therapy are more effective with or without radiation therapy in treating breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of mastectomy, chemotherapy, and/or hormone therapy with or without radiation therapy in treating women who have stage II breast cancer.

Detailed description

OBJECTIVES: * Compare overall and disease-free survival in women with stage II breast cancer with one to three positive nodes treated with radiotherapy vs observation only after mastectomy and adjuvant chemotherapy and/or hormonal therapy. * Compare local regional control in patients treated with these regimens. * Assess the potential toxic effects of radiotherapy in this patient population. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior systemic hormonal therapy (chemotherapy with or without hormonal therapy vs hormonal therapy alone), prior taxane exposure (yes vs no), and duration of chemotherapy (no chemotherapy vs less than 3 months vs 3-5 months vs 6 months or more). Patients are randomized to one of two treatment arms. * Arm I: Patients undergo radiotherapy 5 days a week for 5 weeks. * Arm II: Patients are observed for disease progression. Patients are followed every 6 months for 2 years and then annually for 15 years. PROJECTED ACCRUAL: A total of 2,500 patients (1,250 per treatment arm) will be accrued for this study within 5 years.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
RADIATION	radiation therapy
PROCEDURE	surgery	surgery

Timeline

• Start date: 2000-06-01
• Primary completion: 2005-03-01
• Completion: 2005-03-01
• First posted: 2003-01-27
• Last updated: 2013-01-24

Locations

1 site across 1 country: Canada