Radiation Therapy in Treating Women With Stage I or Stage II Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT00002873
- Lead Sponsor
- Radiation Therapy Oncology Group
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (232)
Veterans Affairs Medical Center - Birmingham
🇺🇸Birmingham, Alabama, United States
University of Alabama Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
Huntsville Hospital System
🇺🇸Huntsville, Alabama, United States
Urology Associates - Mobile AL
🇺🇸Mobile, Alabama, United States
MBCCOP - University of South Alabama
🇺🇸Mobile, Alabama, United States
Alabama Oncology, LLC
🇺🇸Montgomery, Alabama, United States
Radiation Oncology Associates of West Alabama
🇺🇸Tuscallosa, Alabama, United States
Providence Cancer Therapy Center
🇺🇸Anchorage, Alaska, United States
Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
Providence Saint Joseph Medical Center - Burbank
🇺🇸Burbank, California, United States
Scroll for more (222 remaining)Veterans Affairs Medical Center - Birmingham🇺🇸Birmingham, Alabama, United States