Radiation Therapy in Treating Women With Stage I or Stage II Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00002873|
Recruitment Status : Completed
First Posted : September 2, 2004
Last Update Posted : July 19, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Radiation: brachytherapy||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|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|
|Actual Primary Completion Date :||June 2007|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002873
Show 232 Study Locations
|Study Chair:||Robert R. Kuske, MD||Ochsner Cancer Institute at Ochsner Clinic Foundation|