NCT06120803 Esomeprazole and Radiation Induced Esophagitis
| NCT ID | NCT06120803 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Rush University Medical Center |
| Condition | Radiation Esophagitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2024-03-01 |
| Primary Completion | 2027-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 48 participants in total. It began in 2024-03-01 with a primary completion date of 2027-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
Inclusion 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. Exclusion Criteria: * 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).
Contact & Investigator
Soumyajit M Roy, PhD
PRINCIPAL INVESTIGATOR
Rush University Medical Center
Frequently Asked Questions
Who can join the NCT06120803 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Radiation Esophagitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06120803 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06120803 currently recruiting?
Yes, NCT06120803 is actively recruiting participants. Contact the research team at soumyajit_roy@rush.edu for enrollment information.
Where is the NCT06120803 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT06120803 clinical trial?
NCT06120803 is sponsored by Rush University Medical Center. The principal investigator is Soumyajit M Roy, PhD at Rush University Medical Center. The trial plans to enroll 48 participants.