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Phase 2Recruiting

Esomeprazole and Radiation Induced Esophagitis

Sponsored by Rush University Medical Center

About this study

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).

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 appropriately, acute severe radiation induced esophagitis might also progress to long-term consequences such as esophageal stricture. Existing management of radiation induced esophagitis entails addressi…

Where this study is enrolling

Who can participate

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).

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.