RECRUITING

Esomeprazole and Radiation Induced Esophagitis

Conditions

Radiation Esophagitis Locally Advanced Lung Carcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Effect of Esomeprazole on Radiation Induced Esophagitis in Non-small Cell Lung Cancer (EERENs): A Phase II Single Arm Study

Quick Facts

Study Start:2024-03-01

Study Completion:2028-01-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06120803

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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). * Double inclusion in any ongoing trial (if the other trial permits) will be allowed.	* 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).

Inclusion Criteria

Exclusion Criteria

* 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).
* Double inclusion in any ongoing trial (if the other trial permits) will be allowed.

* 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).

Contacts and Locations

Study Contact

Soumyajit Roy, MD, MSc.(c)

CONTACT

312-942-5655

soumyajit_roy@rush.edu

Gaurav Marwaha, MD

CONTACT

312-942-5751

gaurav_marwaha@rush.edu

Principal Investigator

Soumyajit M Roy, PhD

PRINCIPAL_INVESTIGATOR

Rush University Medical Center

Study Locations (Sites)

Rush University Medical Center

Chicago, Illinois, 60612

United States

Collaborators and Investigators

Sponsor: Rush University Medical Center

Soumyajit M Roy, PhD, PRINCIPAL_INVESTIGATOR, Rush University Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-01

Study Completion Date2028-01-31

Study Record Updates

Study Start Date2024-03-01

Study Completion Date2028-01-31

Terms related to this study

Additional Relevant MeSH Terms

Radiation Esophagitis
Locally Advanced Lung Carcinoma