Aperçu

Éligibilité

Détails de la conception

Bras et interventions

Mesures des résultats

Sites d'essai

Source : NCT06120803

Recrutement en cours

EERENs: Esomeprazole and Radiation Induced Esophagitis

Interventionnel

Phase 2

Rush University Medical Center

Sponsor: Rush University Medical Center

Dernière synchronisation : 13 avril 2025
Avis - Les informations proviennent de registres publics et peuvent ne pas refléter les changements en temps réel sur le site 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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Catégorie de traitement

Autres médicaments

Mutations requises

Aucun

Essai commencé

1 mars 2024

Dernière mise à jour par le sponsor

13 avril 2025

Achèvement estimé

30 décembre 2027

Contact de l'étude

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

E-mail:soumyajit_roy@rush.edu

Téléphone:312-942-5655

Nom:Gaurav Marwaha, MD

E-mail:gaurav_marwaha@rush.edu

Téléphone:312-942-5751

Éligibilité

Critères d'inclusion

* 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.

Critères d'exclusion

* 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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Détails de la conception

AllocationN/A

Modèle d'interventionSingle Group Assignment

MasquageNone (Open Label)

Nombre à inscrire48

Bras et interventions

Bras

Interventions

Type : Experimental

Description : 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.

Interventions :

Esomeprazole 40 mg

Mesures des résultats

Mesures des résultats primaires

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.

Mesures des résultats secondaires

Aucun

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Sites d'essai

Cette étude compte 1 site d'essai

Rush University Medical Center

Chicago, Illinois, US

Nom:Soumyajit Roy, MD

Recrutement en cours

Chicago, Illinois, 60612 US

Rush University Medical Center

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