Esomeprazole and Radiation Induced Esophagitis

• Status: Recruiting
• Trial end date: 2028-01-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rush University Medical Center
• Treatments: Esomeprazole

Criteria

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 concomitant chemotherapy.

• Patient has Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2.

• Women of childbearing potential (WOCBP) must have a negative pregnancy test (serum or urine HCG) within 2 weeks of enrollment).

• Double inclusion in any ongoing trial (if the other trial permits) will be allowed.

Exclusion Criteria:

• Patient has history of gastroesophageal junction or stomach cancer.

• Patient has history of pre-existing severe or very severe dysphagia.

• Patient has history of severe liver disease, acute or subacute systemic lupus erythematosus.

• Patient has interstitial nephritis.

• Patient has history of peptic ulcer disease.

• Patient has prior history of upper gastrointestinal bleeding.

• Patient has a history of thoracic radiotherapy within 2 years of enrollment.

• Patient has known or suspected allergic response and prior adverse drug reaction with proton pump inhibitors.

• Patient is currently on clopidogrel, nelfinavir, rilpivirine, methotrexate, rifampin, digoxin, tacrolimus, or phenytoin as these may have major drug interaction with esomeprazole.

• Patients without concomitant chemoradiotherapy and with estimated maximum dose to esophagus of less than 30 Gy (EQD2).