Status:
RECRUITING
Esomeprazole and Radiation Induced Esophagitis
Lead Sponsor:
Rush University Medical Center
Conditions:
Radiation Esophagitis
Locally Advanced Lung Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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).
Detailed 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 adv...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06120803
Start Date
March 1 2024
End Date
June 30 2028
Last Update
April 13 2025
Active Locations (1)
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1
Rush University Medical Center
Chicago, Illinois, United States, 60612