Phase II Study of Postoperative, Cardiac-Sparing Proton Radiotherapy for Women With Stage III,Loco-Regional, Non-Metastatic Breast Cancer
The proposed Phase II study is seeking to build clinical data as a continuation of the
original dosimetric analysis published by Ares et al. performed at Paul-Scherrer Institute
(PSI). That comparison demonstrated a benefit form proton planning for patients with
non-metastatic breast cancer requiring complex, loco-regional, postoperative radiotherapy.1
The advantages of PT were improved target coverage compared to standard photon irradiation
and reduced dose to heart, lungs and contralateral breast.
The study goal is to demonstrate a "meaningful benefit" of proton therapy for women with
loco-regionally advanced breast cancer. The main clinical endpoints of this trial are the
reduction of cardiac morbidity and mortality (coronary artery disease, myocardial
infarction, cardiac insufficiency) and the reduction of contralateral, second breast cancer.
Both adverse events are presently associated with external beam photon therapy. Both goals
require longitudinal follow-up of minimum 5-10 years. Despite the logistical challenges of
long term follow-up, the effort is needed in view of the compelling preclinical evidence of
dose avoidance or even absence of radiation dose to heart and contralateral breast uniquely
accomplishable by protons only.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determination of the rates of acute and late toxicities (acute and late adverse events) resulting from proton therapy radiation treatment.
Eugen Hug, MD
Proton Collaborative Group
United States: Institutional Review Board
|ProCure Proton Therapy Center||Warrenville, Illinois 60555|
|ProCure Proton Therapy Center||Oklahoma City, Oklahoma 73142|
|Princeton ProCure Managment LLC||Somerset, New Jersey 08873|