The purpose of this study is to determine if lumpectomy followed by Intraoperative Electron Radiation Therapy (IOeRT) as a single, full dose partial breast irradiation will have as good or better results in preventing recurrence of local breast cancer, cosmetic appearance and early and late side effects.
See points VIII inclusion/exclusion criteria Operation: * Lumpectomy, steninal node biopsy * IOeRT After Surgery: * Meet with a medical oncologist and discuss if chemotherapy and/or hormone therapy is recommended as part of your treatment course. In some cases, pathology results may indicate the need for removal of additional lymph nodes. The doctor will review pathology and discuss if additional surgery is required. * Chemotherapy (if indicated) * Hormone therapy (if indicated) Follow-Up * Visits will be completed with the surgeon, radiation oncologist and research staff as the protocol indicates. * Assessements of acute toxicity according to CTC-toxicity scoring system * Assessments of late toxicity according to LENT-SOMA scoring systems * Assessment of cosmetic outcome according to scoring system and photo documentation in standardized positions.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
A single dose of 21 Gy calculated such that the 90% isodose line encompasses the posterior of the tumor bed will be administered.
Avera Cancer Institute
Sioux Falls, South Dakota, United States
Proportion of patients who are free of breast cancer.
Patients will be followed by standard of care breast imaging along with appointments with breast surgeon, radiation oncologist and medical oncologist if indicated.
Time frame: 10 years
Local recurrance rate with acute toxicity and cosmetic evaluations
AEs and Lent Soma will be assessed for acute toxicity. We will use a 20% toxicity cutoff, the protocol would be stopped if 2/10 were determined to have developed significant toxicities, grade 3 or greater, at the first 6-month follow-up visit. 2/10 patients at 6-months follow-up, 4/20 patients at 1-year follow-up, 6/30 at 18-months follow-up, 8/40 at 24-months follow-up, 10/50 at 30-months follow-up, 12/60 at 36-months follow-up, 14/70 at 42-months follow-up, 16/80 at 48-months follow-up, 18/90 at 54-months and 20/100 at 60-months follow-up. Cosmetic evaluations will be completed by the patient and radiation oncologist an via breast exams, questionnaires and breast photo documentation.
Time frame: 10 years
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