Effect of Esomeprazole on Radiation Induced Esophagitis in Non-small Cell Lung Cancer (EERENs): A Phase II Single Arm Study
Rush University Medical Center
Summary
Thoracic radiation therapy combined with chemotherapy (with or without immunotherapy) is the cornerstone of management in patients with locally advanced non-small cell lung cancer (NSCLC).
Description
Thoracic radiation therapy combined with chemotherapy (with or without immunotherapy) is the cornerstone of management in patients with locally advanced non-small cell lung cancer (NSCLC). Despite advancement in radiation delivery techniques, about 1/3 of patients who undergo thoracic radiation therapy (TRT) for advanced NSCLC suffer from symptoms of radiation-induced inflammation of the esophagus, also known as radiation-induced esophagitis (RE). Radiation induced esophagitis can have detrimental effect on quality-of-life and can result in unplanned treatment interruptions. If not treated app…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patient is ≥ 18 years of age. * Patient or patient's legal representative is willing and able to provide written informed consent and HIPAA authorization prior to performance of any study related activity. * Patient is willing and able to comply with scheduled visits and treatment schedules. * Patient has histopathologically confirmed diagnosis of NSCLC clinical stage III (as per the 8th edition of American Joint Committee on Cancer Staging). * Patients will receive thoracic radiation with estimated maximum dose to esophagus of at least 30 Gy (EQD2) in combination with c…
Interventions
- DrugEsomeprazole 40 mg
Enrolled patients will receive 40 mg of esomeprazole (two pills of 20 mg strength of esomeprazole) once daily before breakfast for the entire duration of TRT (including the weekends and any interim gap period) and for two weeks after completion of thoracic radiation therapy.
Location
- Rush University Medical CenterChicago, Illinois