Resumen

Elegibilidad

Detalles del diseño

Brazos e Intervenciones

Medidas de resultado

Sitios del ensayo

Fuente: NCT06120803

Reclutando

EERENs: Esomeprazole and Radiation Induced Esophagitis

Intervencionista

Fase 2

Rush University Medical Center

Patrocinador: Rush University Medical Center

Última actualización: 13 de abril de 2025
Aviso: La información proviene de registros públicos y puede no reflejar cambios en tiempo real en el centro local.

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).

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Categoría de tratamiento

Otros medicamentos

Erforderliche Mutationen

Ninguna

Ensayo iniciado

1 de marzo de 2024

Última actualización por el patrocinador

13 de abril de 2025

Finalización estimada

30 de diciembre de 2027

Contacto del estudio

Nombre:Soumyajit Roy, MD, MSc.(c)

Correo electrónico:soumyajit_roy@rush.edu

Teléfono:312-942-5655

Nombre:Gaurav Marwaha, MD

Correo electrónico:gaurav_marwaha@rush.edu

Teléfono:312-942-5751

Elegibilidad

Criterios de inclusión

* 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.

Criterios de exclusión

* 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).

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Detalles del diseño

AsignaciónN/A

Modelo de intervenciónSingle Group Assignment

EnmascaramientoNone (Open Label)

Número a inscribir48

Brazos e Intervenciones

Brazos

Intervenciones

Tipo: Experimental

Descripción: 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.

Intervenciones:

Esomeprazole 40 mg

Medidas de resultado

Medidas de resultado primarias

Grade 2 or higher radiation induced esophagitisAt 2 weeks after completion of thoracic radiation therapy and at 3 months since start of radiation therapy

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.

Medidas de resultado secundarias

Ninguno

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Sitios del ensayo

Este estudio tiene 1 sitio de ensayo

Rush University Medical Center

Chicago, Illinois, US

Nombre:Soumyajit Roy, MD

Reclutando

Chicago, Illinois, 60612 US

Rush University Medical Center

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