Radiation EsophagitisPhase 2EERENsNCT06120803
Esomeprazole and Radiation Induced Esophagitis
A Phase 2 study testing Esomeprazole 40 mg in people with Radiation Esophagitis and Locally Advanced Lung Carcinoma, run by Rush University Medical Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation Esophagitis, Locally Advanced Lung Carcinoma
- What is being tested?
- Esomeprazole 40 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2024to 30 Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rush University Medical Center
Chicago, Illinois, 60612
Soumyajit Roy, MD, 312-942-5655, soumyajit_roy@rush.edu
About this study
Official title: Effect of Esomeprazole on Radiation Induced Esophagitis in Non-small Cell Lung Cancer (EERENs): A Phase II Single Arm Study
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).
Read the detailed description
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). Despite advancement in radiation delivery techniques, about 1/3 of patients who undergo thoracic radiation therapy (TRT) for advanced NSCLC suffer from symptoms of radiation-induced inflammation of the esophagus, also known as radiation-induced esophagitis (RE). Radiation induced esophagitis can have detrimental effect on quality-of-life and can result in unplanned treatment interruptions. If not treated appropriately, acute severe radiation induced esophagitis might also progress to long-term consequences such as esophageal stricture. Existing management of radiation induced esophagitis entails addressing the symptoms and nutritional needs. Anecdotal reports have shown improvement in radiation induced esophagitis symptoms with proton pump inhibitors (PPI); however, no robust prospective evidence exists to support use of PPI to manage radiation induced esophagitis to mitigate detrimental impact on QoL. Recent studies have shown that the PPI esomeprazole has antioxidant, anti-inflammatory and antifibrotic properties; and it potentiates the effect of ionizing radiation on cancer cells.
The investigators hypothesize that the use of esomeprazole will reduce the frequency of symptomatic (grade ≥2) radiation induced esophagitis compared to reported rates in literature. To address this hypothesis, the investigators propose a phase II study with locally advanced non-small cell lung cancer (NSCLC) patients with the following objectives: The primary objective is to evaluate the frequency of acute symptomatic RE and associated patient-reported symptoms with use of 40 mg of esomeprazole (two pills of 20 mg strength of esomeprazole) once daily for the duration of TRT and for two weeks after completion of TRT. Finally, as exploratory objectives, the investigators plan to identify orthogonal biomarkers that predict radiation induced esophagitis (RE) in the context of using esomeprazole.
The frequency of symptomatic radiation induced esophagitis at 2 weeks after RT completion and at 3 months from the start of TRT will be documented in a cohort of patients with locally advanced NSCLC receiving TRT (EQD2 of 45 Gy or higher with concomitant chemotherapy and estimated esophageal maximum dose of 30 Gy or higher). Both clinician-reported metrics (Common Terminology Criteria for Adverse Events version 5.0) and patient-reported metrics (Patient-Reported Outcomes version of the CTCAE [PRO-CTCAE]) will be used.
As part of exploratory objectives, investigators will investigate correlative biomarkers that could predict radiation-induced esophagitis in the context of using esomeprazole.
This work is significant as it will provide important evidence to support the use of esomeprazole, a readily available over-the-counter medication with thoracic radiation therapy to reduce the frequency of symptomatic radiation induced esophagitis given the lack of clinical evidence in the existing literature supporting this premise.
- Being tested
- Esomeprazole 40 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esomeprazole 40 mgDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Esomeprazole 40 mg daily with thoracic radiation therapy and concomitant chemotherapy | Experimental | 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. Receives: Drug: Esomeprazole 40 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade 2 or higher radiation induced esophagitis
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.
Measured: At 2 weeks after completion of thoracic radiation therapy and at 3 months since start of radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start1 Mar 2024
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation EsophagitisStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Soumyajit M Roy, PhD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06120803
- Sponsor's protocol ID
- ORA22072007
- Acronym
- EERENs
- Status last verified
- Aug 2026
- First submitted
- 1 Nov 2023
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Information on IPD sharing will be determined at the study completion
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Esomeprazole on Radiation Induced Esophagitis in Non-small Cell Lung Cancer (EERENs): A Phase II Single Arm Study
- ClinicalTrials.gov ID
- NCT06120803
- Acronym / sponsor ID
- EERENs / ORA22072007
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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). Despite advancement in radiation delivery techniques, about 1/3 of patients who undergo thoracic radiation therapy (TRT) for advanced NSCLC suffer from symptoms of radiation-induced inflammation of the esophagus, also known as radiation-induced esophagitis (RE). Radiation induced esophagitis can have detrimental effect on quality-of-life and can result in unplanned treatment interruptions. If not treated appropriately, acute severe radiation induced esophagitis might also progress to long-term consequences such as esophageal stricture. Existing management of radiation induced esophagitis entails addressing the symptoms and nutritional needs. Anecdotal reports have shown improvement in radiation induced esophagitis symptoms with proton pump inhibitors (PPI); however, no robust prospective evidence exists to support use of PPI to manage radiation induced esophagitis to mitigate detrimental impact on QoL. Recent studies have shown that the PPI esomeprazole has antioxidant, anti-inflammatory and antifibrotic properties; and it potentiates the effect of ionizing radiation on cancer cells.
The investigators hypothesize that the use of esomeprazole will reduce the frequency of symptomatic (grade ≥2) radiation induced esophagitis compared to reported rates in literature. To address this hypothesis, the investigators propose a phase II study with locally advanced non-small cell lung cancer (NSCLC) patients with the following objectives: The primary objective is to evaluate the frequency of acute symptomatic RE and associated patient-reported symptoms with use of 40 mg of esomeprazole (two pills of 20 mg strength of esomeprazole) once daily for the duration of TRT and for two weeks after completion of TRT. Finally, as exploratory objectives, the investigators plan to identify orthogonal biomarkers that predict radiation induced esophagitis (RE) in the context of using esomeprazole.
The frequency of symptomatic radiation induced esophagitis at 2 weeks after RT completion and at 3 months from the start of TRT will be documented in a cohort of patients with locally advanced NSCLC receiving TRT (EQD2 of 45 Gy or higher with concomitant chemotherapy and estimated esophageal maximum dose of 30 Gy or higher). Both clinician-reported metrics (Common Terminology Criteria for Adverse Events version 5.0) and patient-reported metrics (Patient-Reported Outcomes version of the CTCAE [PRO-CTCAE]) will be used.
As part of exploratory objectives, investigators will investigate correlative biomarkers that could predict radiation-induced esophagitis in the context of using esomeprazole.
This work is significant as it will provide important evidence to support the use of esomeprazole, a readily available over-the-counter medication with thoracic radiation therapy to reduce the frequency of symptomatic radiation induced esophagitis given the lack of clinical evidence in the existing literature supporting this premise.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Esomeprazole 40 mg daily with thoracic radiation therapy and concomitant chemotherapy | Experimental | Drug: Esomeprazole 40 mgEnrolled 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Esomeprazole 40 mgEnrolled 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. | Drug | Esomeprazole 40 mg daily with thoracic radiation therapy and concomitant chemotherapy |
Primary outcome
Grade 2 or higher radiation induced esophagitis
Time frame: At 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: Undecided. Information on IPD sharing will be determined at the study completion
Related trials for Radiation Esophagitis
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Risk-Adapted Segmental Esophagus-Sparing Radiotherapy for Definitive Non-Small Cell Lung Cancer
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Immunonutrition Reduces Acute Esophagitis After Thoracic Radiotherapy in Lung Cancer
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Soumyajit M Roy, PhD principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Esomeprazole 40 mg in people with Radiation Esophagitis and Locally Advanced Lung Carcinoma, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Soumyajit Roy, MD, MSc.(c) (312-942-5655, soumyajit_roy@rush.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grade 2 or higher radiation induced esophagitis (time frame: At 2 weeks after completion of thoracic radiation therapy and at 3 months since start of radiation therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.