Intensity Modulated Radiation Therapy for Breast Cancer: A Phase I Feasibility Study
IMRT treatment uses a computer-controlled x-ray (CT) to deliver radiation beams at several
different angles and strengths to deliver precise doses to the regions at risk for
recurrence of breast cancer while reducing or sparing the dose to critical structures
(heart, lungs) and nearby normal tissue.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluate the feasibility of adjuvant comprehensive radiation therapy via IMRT with daily set-up position verified using 3D verification
The study will be deemed infeasible if greater than 10% of enrolled patients have at least one of the following outcomes: Patient cannot be given the treatment because her anatomy is such that a dosimetrically satisfactory treatment plan cannot be devised for her. Within 1 year of protocol registration, the patient develops radiation pneumonitis toxicity of greater than or equal to grade 3 by CTCAE scales. Within 1 year of protocol registration, the patient develops any local or regional breast cancer recurrence. Within 1 year of protocol registration, the patient dies from causes judged to be related to her treatment.
Within 1 year of protocol registration
Imran Zoberi, MD
Washington University School of Medicine
United States: Institutional Review Board
07-1077 / 201106403
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