NCT06120803
Esomeprazole and Radiation Induced Esophagitis
Recruiting
PHASE2Ages 18+InterventionalTreatmentRush University Medical CenterInvestigator-initiated
~48 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:Esomeprazole 40 mg
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Grade 2 or higher radiation induced esophagitis
Measured over At 2 weeks after completion of thoracic radiation therapy and at 3 months since start of radiation therapy
Conditions
Where it's being run
1 sites across 1 statesIllinois1
Study leadership
- Soumyajit M Roy, PhD · PRINCIPAL_INVESTIGATOR · Rush University Medical Center
Who to contact
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Do you actually qualify for this trial?
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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).
What this trial measures
- Grade 2 or higher radiation induced esophagitisAt 2 weeks after completion of thoracic radiation therapy and at 3 months since start of radiation therapy
The primary objective of this study is to determine the effect of esomeprazole on the frequency of acute symptomatic RE after thoracic radiotherapy (TRT) in a cohort of patients with locally advanced NSCLC treated with definitive TRT. Both clinician-reported metrics (CTCAE) and patient-reported metrics (Patient-Reported Outcomes version of the CTCAE) will be used.