Esomeprazole and Radiation Induced Esophagitis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRush University Medical Center
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Esomeprazole 40 mg
DrugEnrolled 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.
Treatment groups
48 Participants
are divided into 1 treatment groupGroup A: Esomeprazole 40 mg daily with thoracic radiation therapy and concomitant chemotherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Grade 2 or higher radiation induced esophagitis
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.
Time frame
At 2 weeks after completion of thoracic radiation therapy and at 3 months since start of radiation therapySponsors and contacts
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Source ClinicalTrials.gov