Phase II Study of Esomeprazole with Thoracic Radiation and Chemotherapy for Locally Advanced Non-Small Cell Lung Cancer to Reduce Radiation-Induced Esophagitis

What this Trial Is About

Researchers are investigating the use of esomeprazole to reduce symptoms of radiation-induced esophagitis in patients with locally advanced non-small cell lung cancer NSCLC undergoing thoracic radiation therapy combined with chemotherapy, with or without immunotherapy. Radiation-induced esophagitis is an inflammation of the esophagus that can significantly affect quality of life and may cause treatment interruptions or long-term complications such as esophageal stricture. This phase II study aims to provide evidence on the benefits of esomeprazole, a proton pump inhibitor with anti-inflammatory properties, in managing these symptoms during treatment. Participants will receive 40 mg of esomeprazole daily, taken as two 20 mg pills before breakfast, throughout the entire period of thoracic radiation therapy and for two weeks following its completion. The thoracic radiation therapy will be administered according to the treating physicians discretion, combined with chemotherapy. The study includes a single treatment arm and focuses on monitoring the frequency and severity of radiation-induced esophagitis symptoms during and after treatment. During the study, researchers will collect both clinician-reported and patient-reported measures of esophagitis severity at two weeks post-radiation and three months after starting radiation therapy. They will also explore biomarkers that may predict susceptibility to radiation-induced esophagitis when using esomeprazole. Patients will be monitored for symptoms and side effects, with the primary outcome being the occurrence of grade 2 or higher esophagitis. The total duration of participation spans from the start of radiation therapy through follow-up assessments at three months.

Esomeprazole and Radiation Induced Esophagitis