Phase III Randomized Trial of Proton Beam Therapy (PBT) versus Intensity Modulated Photon Radiotherapy (IMRT) for the Treatment of Esophageal Cancer (NRG-GI006)

General Information Age Group Adults Status Recruiting Protocol Number NCT03801876 Background Information The purpose of this study is to compare the usual treatment of chemotherapy plus photon radiation therapy followed by surgery (if your cancer is able to be surgically removed) to chemotherapy plus proton radiation therapy followed by surgery (if your cancer is able to be surgically removed). The addition of proton radiation therapy to the usual chemotherapy could extend survival. The usual photon radiation therapy uses high-energy x-rays to send the radiation inside the body to the tumor and is the most common radiation treatment approach for esophageal cancer. Proton radiation therapy uses a beam of protons (rather than x-rays) to send radiation inside the body to the tumor. This is the type of radiation therapy being studied in this trial. Because protons act differently inside the body than x-rays, proton radiation may result in better survival and cause fewer side effects. Both photon and proton therapy precisely deliver radiation to the tumor and use special images to help guide accurate delivery of a full dose of radiation to the tumor without damaging much of the healthy tissue around it. Both proton and photon therapy have already been tested for safety. Both of these types of radiation may shrink tumors, but both could also cause side effects, and doctors and scientists do not know if one is better than the other or if they work equally well. This study will help the study doctors find out if proton radiation is better, the same, or worse than the usual approach. To decide if it is better, the study doctors will be looking to see if the study approach increases the life of patients by 6 months or more and results in fewer side effects compared to the usual approach. This trial is part of the National Clinical Trials Network (NCTN) program, which is sponsored by the National Cancer Institute (NCI). The trial will be led by NRG Oncology with the participation of the network of NCTN organizations: the Alliance for Clinical Trials in Oncology; ECOG-ACRIN Medical Group; and SWOG. Offered At Inova Schar Cancer Institute 8081 Innovation Park Drive Fairfax, VA 22031 A Department of Inova Fairfax Hospital Eligibility Information 18 years of age or older Histologically proven diagnosis of adenocarcinoma or squamous cell carcinoma of the thoracic esophagus or gastroesophageal junction (Siewert I-II) Additional eligibility in protocol Ineligibility Information Cervical esophageal cancers arisen from 15-18 cm from the incisors Pregnancy/nursing Patients with T4b disease according to the AJCC 8th Edition Definitive clinical or radiologic evidence of metastatic disease HIV positive with CD4 count < 200 cells/microliter. Note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count ≥ 200 cells/microliter within 30 days prior to registration Additional ineligibility in protocol For additional information, please see: https://www.clinicaltrials.gov/ct2/show/ NCT03801876 Contact Information Contact Name Sangeetha Moturi Contact Phone 571-472-0343 Contact Email Send Email