S9927 Radiation Therapy After Surgery, Chemotherapy, and/or Hormone Therapy in Stage II Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Procedure: surgeryRadiation: radiation therapy
- Registration Number
- NCT00005983
- Lead Sponsor
- SWOG Cancer Research Network
- Brief 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 98
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description surgery surgery surgery followed by observation surgery followed by RT radiation therapy Surgery followed by radiation therapy surgery followed by RT surgery Surgery followed by radiation therapy
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Cancer Care Ontario-Hamilton Regional Cancer Centre
🇨🇦Hamilton, Ontario, Canada