Esomeprazole and Radiation Induced Esophagitis

NCT06120803 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: ORA22072007
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Radiation Esophagitis; Locally Advanced Lung Carcinoma

Outcome Measures

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.

  At 2 weeks after completion of thoracic radiation therapy and at 3 months since start of radiation therapy

Study Arms (1)

Esomeprazole 40 mg daily with thoracic radiation therapy and concomitant chemotherapy

EXPERIMENTAL

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.

Drug: Esomeprazole 40 mg

Interventions

Esomeprazole 40 mg DRUG

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.

Esomeprazole 40 mg daily with thoracic radiation therapy and concomitant chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

MeSH Terms

Interventions

Esomeprazole

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Soumyajit M Roy, PhD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Soumyajit Roy, MD, MSc.(c)

CONTACT

312-942-5655; soumyajit_roy@rush.edu

Gaurav Marwaha, MD

CONTACT

312-942-5751; gaurav_marwaha@rush.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician, Department of Radiation Oncology

Study Record Dates

• First Submitted: November 1, 2023
• First Posted: November 7, 2023
• Study Start: March 1, 2024
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: April 13, 2025

Record last verified: 2025-04

Locations

US (1)