Single arm study to assess the effectiveness of single dose intraoperative radiation therapy in patient with in situ and early stage breast cancer.
The purpose of this clinical study is to assess the effectiveness of IORT, using an electronic brachytherapy system, in patients with limited-volume in situ and early stage breast cancer, with endpoints of: * Local recurrence in early stage breast cancer patients treated with IORT. * Toxicity associated with IORT. * Long-term disease-specific and overall survival * Cosmetic results using the Harvard Scale at start and follow-up periods in patients treated with IORT. * Quality of life in patients treated with IORT. * Health care costs associated with IORT.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
500
Intraoperative radiation therapy at the time of partial mastectomy in early stage breast cancer
Virginia Mason Medical Center
Seattle, Washington, United States
Local Disease Relapse
Patients are evaluated clinically at 3 months, 6 months, 9 months, 1 year and every six months for 10 years for disease recurrence. In addition to clinical exams, yearly mammograms and other imaging studies as deemed appropriate will be obtained to rule out recurrent disease. Recurrent disease will be defined as cancer recurrence within 2cm of site of original tumor bed (marked by surgical clips).
Time frame: 10 years
Disease specific and overall survival
Disease specific and overall survival will be obtained for all patients in the study.
Time frame: 10 years
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