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Esomeprazole for Esophagitis (EERENs Trial)

Phase 2
Recruiting
Led By Soumyajit M Roy, PhD
Research Sponsored by Rush University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 2 weeks after completion of thoracic radiation therapy and at 3 months since start of radiation therapy
Awards & highlights

Summary

This trial focuses on using a combination of radiation therapy and chemotherapy (with or without immunotherapy) as the main treatment for patients with advanced non-small cell lung cancer.

Who is the study for?
This trial is for adults over 18 with stage III non-small cell lung cancer (NSCLC) who are about to receive thoracic radiation and chemotherapy. They must be able to consent, follow the visit schedule, and have an ECOG score of 0-2. Women who can bear children need a negative pregnancy test. Participation in another trial may be okay if allowed.
What is being tested?
The study tests whether Esomeprazole 40 mg can prevent or reduce esophagitis caused by radiation therapy in NSCLC patients receiving combined chemo (and possibly immunotherapy).
What are the potential side effects?
Esomeprazole may cause side effects like headache, diarrhea, nausea, stomach pain, dry mouth, dizziness or allergic reactions. Long-term use might increase the risk of bone fractures.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 2 weeks after completion of thoracic radiation therapy and at 3 months since start of radiation therapy
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 2 weeks after completion of thoracic radiation therapy and at 3 months since start of radiation therapy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Grade 2 or higher radiation induced esophagitis

Trial Design

1Treatment groups
Experimental Treatment
Group I: Esomeprazole 40 mg daily with thoracic radiation therapy and concomitant chemotherapyExperimental Treatment1 Intervention
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 (TRT). TRT will be delivered as per the discretion of the treating physicians.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Esomeprazole 40 mg
2007
Completed Phase 4
~3230

Find a Location

Who is running the clinical trial?

Rush University Medical CenterLead Sponsor
431 Previous Clinical Trials
158,353 Total Patients Enrolled
Soumyajit M Roy, PhDPrincipal InvestigatorRush University Medical Center
~32 spots leftby Jul 2027
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