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Esomeprazole 40 mg daily with thoracic radiation therapy and concomitant chemotherapy 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

EERENs Trial 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.Check my eligibility

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).See study design

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.

EERENs Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Grade 2 or higher radiation induced esophagitis

EERENs 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Rush University Medical CenterLead Sponsor

423 Previous Clinical Trials

164,075 Total Patients Enrolled

Soumyajit M Roy, PhDPrincipal InvestigatorRush University Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research actively seeking participants at the moment?

"Per clinicaltrials.gov, patient recruitment is ongoing for this study. The trial was first listed on 3/1/2024 and most recently revised on 3/28/2024."

Answered by AI

What is the current number of patients being recruited for participation in this medical study?

"Indeed, the information available on clinicaltrials.gov indicates that this study is actively seeking participants. The trial was initially posted on March 1st, 2024, and last updated on March 28th of the same year. A total of 48 individuals are being sought at a single research site."

Answered by AI

Has the combination of daily 40 mg Esomeprazole with thoracic radiation therapy and simultaneous chemotherapy been sanctioned by the FDA?

"In this Phase 2 trial, the safety of Esomeprazole 40 mg in combination with thoracic radiation therapy and concurrent chemotherapy is rated at a level of 2 by our team at Power. This rating signifies existing data supporting safety but not efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Esomeprazole and Radiation Induced Esophagitis

Soumyajit Roy 2024. "Esomeprazole and Radiation Induced Esophagitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06120803.

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