Radiation Therapy in Treating Women With Stage I or Stage II Breast Cancer
RATIONALE: Radiation therapy may kill any tumor cells remaining after surgery.
PURPOSE: Phase I/II trial to study the effectiveness of brachytherapy in treating women who have stage I or stage II breast cancer.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A PHASE I/II TRIAL TO EVALUATE BRACHYTHERAPY AS THE SOLE METHOD OF RADIATION THERAPY FOR STAGE I AND II BREAST CARCINOMA|
|Study Start Date:||May 1997|
|Primary Completion Date:||June 2007 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Evaluate the technical feasibility and reproducibility, cosmetic results, complication rates, and local cancer control rate experience with brachytherapy used as the sole method of radiotherapy in women with stage I/II breast cancer treated with tylectomy who have histologically assessed negative surgical margins, less than 4 positive axillary nodes, and no extracapsular nodal extension or extensive intraductal component. II. Reduce the total treatment time of breast irradiation from 6 weeks to 4-5 days in these patients.
OUTLINE: Treatment begins no sooner than 4 days and within 6 weeks after definitive surgery. All patients receive brachytherapy to the target volume (as defined by the excision cavity demarcated by post-tylectomy surgical clips plus 2 cm margin) using iridium-192 implants for dose distribution to five planes. Patients may be treated with either high-dose-rate or low-dose-rate brachytherapy at the institution's discretion. Patients are followed at 2 and 6 weeks after treatment, then at 3, 6, 9 and 12 months, then every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A maximum of 46 patients will be accrued in each group (high-dose rate vs low-dose rate) over 2 years.