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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 2 weeks after completion of thoracic radiation therapy and at 3 months since start of radiation therapy

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

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