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.