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New treatment option for Radiation Esophagitis
Official title Esomeprazole and Radiation Induced Esophagitis
ClinicalTrials.gov ID: NCT06120803
What this study is testing
What is Esomeprazole 40 mg?
Esomeprazole 40 mg is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for radiation esophagitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- Patients will receive thoracic radiation with estimated maximum dose to esophagus of at least 30 Gy (EQD2) in combination with concomitant...
You likely can't join if
- 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.
See the full eligibility 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).
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.