Particle Therapy 2017

A Bayesian randomized trial of Image-Guided Adaptive Conformal Photon vs Proton Therapy, with Concurrent Chemotherapy, for Locally Advanced Non-Small Cell Lung Carcinoma: Treatment Related Pneumonitis and Locoregional Recurrence PI’s: T. Delaney of MGH and R. Mohan of MDACC.

Primary Objective Incidence and time to development of grade > 3 TRP or local failure, whichever comes first, among patients treated with adaptive photon therapy (IGAXT, Group 1) or proton therapy (IGAPT, Group 2) using Bayesian randomization to 74 Gy

Pa#ent Eligibility 1. Pathologically proven, unresected NSCLC (stage II-IIIB )

with excepBon of paBents with solitary brain metastasis without sign of progression (stage IV) 2.Karnofsky performance score of > 70, or ECOG 0-1, < 10% unintenBonal weight loss 3. Measurable disease on chest x-ray, contrast-enhanced CT, or PET scan. 4. Locoregional recurrence aVer surgical resecBon, if suitable for chemoradiaBon, 5. Forced expiratory volume in the first second (FEV1) ≥ 1 liters. 6. Age≥18 years but ≤ 85 years. Hypothesis: Expected 6-month and 12-month treatment failure rates for IGAXT of 30% and 40% Assumption: IGAPT reduces failure rates to 20% and 25%. Sample size : 168 patients.