Single Fraction Intraoperative Radiotherapy With Electrons: An Option in Breast-Conserving Operable Breast Cancer Stages 0, I and II - Prospective, Single-arm Trial
For patients with certain types of breast cancer, one standard treatment is breast
conserving surgery or lumpectomy (surgery to remove abnormal tissue or cancer from the
breast and a small amount of normal tissue around it) followed by breast radiation. The
radiation treatment in this situation usually lasts 3 to 5 1/2 weeks followed by 5-8 daily
localized irradiation (or boost) treatments at the site where the lump was removed. During
this study, the single dose of electron irradiation given at the surgical site during the
operation will replace the radiation given after surgery.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Assessment of acute toxicity of breast irradiation according to CTC-toxicity Scoring - system: End of initial surgical phase: Week 1, 4 First Follow-up investigation: Month 2 Assessment of late toxicity according to NSABP scoring-systems at 6, 12, 24, 36, 48, and 60 months
Lawrence Wagman, M.D.
St. Joseph Hospital of Orange
United States: Food and Drug Administration
12-001 Single Fraction IORT
|St. Joseph Hospital of Orange||Orange, California 92868|