Particle Therapy 2017

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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

Patient Eligibility

Pathologically proven, unresected NSCLC (stage II-IIIB )

with exception of patients with solitary brain metastasis without sign of progression (stage IV)

2.Karnofsky performance score of > 70, or ECOG 0-1, < 10% unintentional weight loss

3. Measurable disease on chest x-ray, contrast-enhanced CT, or PET scan.

4. Locoregional recurrence after surgical resection, if suitable for chemoradiation,

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.