Esomeprazole and Radiation Induced Esophagitis
Effect of Esomeprazole on Radiation Induced Esophagitis in Non-small Cell Lung Cancer (EERENs): A Phase II Single Arm Study
Rush University Medical Center
48 participants
Mar 1, 2024
INTERVENTIONAL
Conditions
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).
Eligibility
Inclusion Criteria8
- 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 Criteria10
- 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).
Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06120803