S9927 Radiation Therapy After Surgery, Chemotherapy, and/or Hormone Therapy in Stage II Breast Cancer
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Randomized Trial of Post-Mastectomy Radiotherapy in Stage II Breast Cancer in Women With One to Three Positive Axillary Nodes Phase III|
|Study Start Date:||June 2000|
|Study Completion Date:||March 2005|
|Primary Completion Date:||March 2005 (Final data collection date for primary outcome measure)|
Active Comparator: surgery
surgery followed by observation
Other Name: surgery
Experimental: surgery followed by RT
Surgery followed by radiation therapy
Radiation: radiation therapy
Other Name: surgery
- 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.
|Cancer Care Ontario-Hamilton Regional Cancer Centre|
|Hamilton, Ontario, Canada, L8V 5C2|
|Study Chair:||Lori J. Pierce, MD||University of Michigan Cancer Center|
|Study Chair:||Michael G. Haddock, MD||Mayo Clinic|
|Study Chair:||Stephen B. Edge, MD||Roswell Park Cancer Institute|
|Study Chair:||Eric A. Strom, MD, FACR||M.D. Anderson Cancer Center|
|Study Chair:||Lawrence J. Solin, MD, FACR||Abramson Cancer Center of the University of Pennsylvania|
|Study Chair:||Lawrence B. Marks, MD||Duke University|
|Study Chair:||Timothy J. Whelan, MD||Margaret and Charles Juravinski Cancer Centre|
|Study Chair:||Melvin Deutsch, MD||UPMC Cancer Center at UPMC Presbyterian|