Safety and Feasibility of Short-course, Accelerated, Hypofractionated Partial Breast Radiotherapy in Women With Early Stage Breast Cancer Using the Contura MLB Breast Brachytherapy Catheter: A Phase II Trial
- To determine local disease control in women with early-stage breast cancer treated with
shorter courses of accelerated partial-breast radiotherapy (APBI) delivered with a
breast brachytherapy applicator.
- To determine whether the acceptable toxicity rates of APBI can be preserved when
further accelerating the dose delivery scheme from the commonly applied ten treatments
delivered twice daily over 5 days to two treatments delivered over 2 days.
- To assess the rate of excellent or good cosmesis at 3 years after shorter courses of
- To identify covariants associated with and predictive of poor cosmetic outcome in
patients treated with an overnight course of APBI.
OUTLINE: This is a multicenter study.
Patients undergo placement of the Contura™ MLB device into the lumpectomy cavity followed by
CT scan for treatment planning. Approximately 1-5 days after balloon placement, patients
undergo accelerated partial-breast radiotherapy twice daily over 2 days.
After completion of study therapy, patients are followed up periodically for 5 years.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Locoregional failure rate at 3 years
Atif Khan, MD
Cancer Institute of New Jersey
United States: Institutional Review Board
|Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School||New Brunswick, New Jersey 08903|