NRG-GI006

Phase III Randomized Trial of Proton Beam Therapy (PBT) Versus Intensity Modulated Photon Radiotherapy (IMRT) for the Treatment of Esophageal Cancer

Principal Investigator

Steven Lin, MD PhD

Status

Disease Site

Gastrointestinal [GI] Esophageal

Phase

III

Developmental Therapeutics

No

Primary Objective

Co-Primary Objectives

To determine if overall survival (OS) is improved with proton beam therapy (PBT) treatment as compared to intensity modulated radiation therapy (IMRT) as part of planned protocol treatment for patients with esophageal cancer.

To determine if OS with PBT is non-inferior to IMRT as part of planned protocol treatment and that there will be less grade 3+ cardiopulmonary toxicity with PBT than with IMRT.

Patient Population

Patients with histologically proven diagnosis of adenocarcinoma or squamous cell carcinoma of the thoracic esophagus or gastroesophageal junction (Siewert I-II); Stage I-IVA, excluding T4b, according to the American Joint Committee on Cancer (AJCC) 8^th edition.

Target Accrual

300