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

Status: Recruiting

Location: See location...

Intervention Type: Drug

Study Type: Interventional

Study Phase: Phase 2

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).

Eligibility

Participation Requirements

Sex: All

Minimum Age: 18

Healthy Volunteers: f

View:

• 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.

Locations

United States

Illinois

Rush University Medical Center

RECRUITING

Chicago

Contact Information

Primary

Soumyajit Roy, MD, MSc.(c)

soumyajit_roy@rush.edu

312-942-5655

Backup

Gaurav Marwaha, MD

gaurav_marwaha@rush.edu

312-942-5751

Time Frame

Start Date: 2024-03-01

Estimated Completion Date: 2028-06-30

Participants

Target number of participants: 48

Treatments

Experimental: Esomeprazole 40 mg daily with thoracic radiation therapy and concomitant chemotherapy

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.

Related Therapeutic Areas

Lung Cancer

Esophagitis

Viral Gastroenteritis

Non-Small Cell Lung Cancer (NSCLC)

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

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