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
Open to Accrual
Date Opened To Accrual
March 06 2019
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) 8th edition.
Target Accrual
300