Gastric CancerPhase 2NCT02794428
Chemoprevention of Gastric Carcinogenesis
A Phase 2 study testing Eflornithine in people with Gastric Cancer and Gastric Intestinal Metaplasia, run by Vanderbilt-Ingram Cancer Center at 2 sites in 2 countries.
Trial summary
A clinical study of the efficacy of oral alpha-difluoromethylornithine (eflornithine or DFMO) in male and female subjects ages 30-60 with gastric premalignant lesions in two high risk regions of Latin America. Read more about this study
- Who is it for?
- Ages 30 to 69 years
- Conditions the study is for
- Gastric Cancer, Gastric Intestinal Metaplasia
- What is being tested?
- Eflornithine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 19 Sep 2016to 1 Jul 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have a history of a premalignant lesion of the stomach, atrophic gastritis or intestinal metaplasia
- Patients must have a pure tone audiometry evaluation to document air conduction within 60 days prior to randomization.
- Patients must have adequate blood counts as evidenced by the following results (obtained within 60 days):
- Blood counts: WBC ≥4.0 /mcL, platelets ≥100,000 /mcL and hemoglobin ≥11.0 g/dL
- Kidney function: Creatinine <1.6 x IULN (institutional upper limit of normal)
- Liver function tests: Bilirubin ≤2.0 mg/dL and AST (SGOT) or ALT (SGPT) ≤2 x IULN
Who cannot join
- Subjects with dysplasia (indeterminate, low grade, high grade) are not eligible for participation
- Patients must not have a significant medical or psychiatric condition that would preclude study completion.
- Patients with hearing loss ≥30 dB in any of the tested frequencies (250 Hz, 500 Hz, 1,000 Hz, 2,000 Hz, 4,000 Hz, 8,000 Hz) are not eligible.
- Patients must not have known hypersensitivity to eflornithine or the excipients.
- Patients must not be receiving corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), or anticoagulants on a regular or intermittent basis.
- Patients must not have a significant cardiovascular disease history, including uncontrolled blood pressure (sBP > 150 mmHg), myocardial infarction, cerebrovascular accident, or heart failure (New York Heart Association Class III, or IV).
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- Patients must not have a history of gastric or esophageal cancer, gastric resection or surgery, peptic ulcer disease (within 6 months), H. pylori treatment (within 6 months), or inflammatory bowel disease.
- No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for >5 years.
- Patients must not be receiving corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), or anticoagulants on a regular or intermittent basis.
- Patients must not be pregnant or nursing (due to eflornithine pregnancy class C). Women and men of reproductive potential must have agreed to use an effective contraceptive method.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Puerto Rico1 site
University of Puerto Rico, Comprehensive Cancer Center
San Juan
About this study
Official title: Targeted Chemoprevention of Gastric Carcinogenesis in High Risk Populations
A clinical study of the efficacy of oral alpha-difluoromethylornithine (eflornithine or DFMO) in male and female subjects ages 30-60 with gastric premalignant lesions in two high risk regions of Latin America.
Read the detailed description
Primary Objective
- The difference in cell DNA damage between patients treated with DFMO and patients treated with placebo at 6 months. The cell DNA damage is measured using the percent positive gastric epithelial cells assessed by IHC for gamma H2AX. The mean difference between the two groups at 6 months will be calculated, accounting for their baseline measurements.
Secondary Objectives
- The difference in cell DNA damage between patients treated with DFMO and patients treated with placebo for 18 months, and then followed for an additional 6 months. The cell DNA damage is measured using the percent positive gastric epithelial cells assessed by IHC for gamma H2AX. The mean difference between the two groups at 18 and 24 months will be calculated, accounting for their baseline measurements.
- The differences in the gastritis histopathology score between patients treated with DFMO and patients treated with placebo for a total of 18 months, and followed for an additional 6 months. The gastritis histopathology score is measured with a quantitative scale 0.0-6.0, for atrophy, intestinal metaplasia, and dysplasia. The mean differences between the two groups at 6, 18, and 24 months will be calculated using mixed models, accounting for their baseline measurements.
- Number of patients with quantitative toxicities. Toxicities will be assessed per CTCAE criteria, and each toxicity will be assigned an adverse event (AE) term according to CTCAE definitions (each AE term = unique representation of a specific event used for medical documentation and scientific analyses), and graded as defined by CTCAE (grade 1 = mild; grade 2 = moderate; grade 3 = severe or significant but not immediately life-threatening; grade 4 = life-threatening; grade 5 = death).
- To evaluate whether candidate single nucleotide polymorphisms (SNPs) relevant to eflornithine (DFMO) efficacy.
- Conditions
- Gastric Cancer, Gastric Intestinal Metaplasia
- Being tested
- Eflornithine, Eflornithine placebo
- Keywords
- Gastric adenocarcinoma, Gastric intestinal metaplasia, Atrophic gastritis, Gastric premalignant lesion
- Medical subject headings
- Stomach Neoplasms, Gastritis, Atrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EflornithineDrug
Eflornithine*, 2 tablets, Oral, Daily for 18 months
Eflornithine placeboOther
Eflornithine placebo, 2 tablets, Oral, Daily for 18 months
| Study group | Role | What they receive |
|---|---|---|
| Eflornithine | Active comparator | Not described Receives: Drug: Eflornithine |
| Eflornithine Placebo | Placebo comparator | Not described Receives: Other: Eflornithine placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric Epithelial Cell DNA Damage, at 6 Months Versus Baseline
The cell DNA damage is measured by the percent positive gastric epithelial cells, as assessed by IHC for gamma H2AX. The mean differences at 6 months versus baseline of the percent positive gastric epithelial cells is compared between the two groups.
Measured: Baseline up to 6 months
Secondary outcomes (5)
Gastric Epithelial Cell DNA Damage, at 18 Months Versus Baseline
The cell DNA damage is measured using the percent positive gastric epithelial cells, as assessed by IHC for gamma H2AX. The mean differences in percent positive gastric epithelial cells at 18 months versus baseline is compared between the two groups.
Measured: Baseline up to 18 months
Gastric Epithelial Cell DNA Damage, at 24 Months Versus Baseline
The cell DNA damage is measured by the percent positive gastric epithelial cells, as assessed by IHC for gamma H2AX. The mean differences at 24 months versus baseline of the percent positive gastric epithelial cells is compared between the two groups.
Measured: Baseline up to 24 months
Change in Gastric Histopathology Score, at 6 Months Versus Baseline
The mean differences in the gastric histopathology score at 6 months versus baseline are calculated, with comparison of the eflornithine and placebo groups. The changes in histology stage are assessed with the validated Correa Histopathology Score system (ranges represent differences in severity and extent): normal mucosa 1, non-atrophic gastritis 2, multifocal atrophic gastritis without intestinal metaplasia 3.25-4.0, gastric intestinal metaplasia 4.3-5.0, dysplasia 5.25-5.75, and cancer 6. The Correa Histopathology Score is based upon the Updated Sydney System biopsy protocol (5 biopsies). The most advanced lesion (highest Correa score) in the stomach represents the summary Correa score for the patient at the given time point.
Measured: Baseline up to 6 months
Change in Gastric Histology Score, at 18 Months Versus Baseline
The mean differences in the gastric histopathology score at 18 months versus baseline are calculated, with comparison of the eflornithine and placebo groups. The changes in histology stage are assessed with the validated Correa Histopathology Score system (ranges represent differences in severity and extent): normal mucosa 1, non-atrophic gastritis 2, multifocal atrophic gastritis without intestinal metaplasia 3.25-4.0, gastric intestinal metaplasia 4.3-5.0, dysplasia 5.25-5.75, and cancer 6. The Correa Histopathology Score is based upon the Updated Sydney System biopsy protocol (5 biopsies). The most advanced lesion (highest Correa score) in the stomach represents the summary Correa score for the patient at the given time point.
Measured: Baseline up to 18 months
Change in Gastric Histology Score, at 24 Months Versus Baseline
The mean differences in the gastric histopathology score at 24 months versus baseline are calculated, with comparison of the eflornithine and placebo groups. The changes in histology stage are assessed with the validated Correa Histopathology Score system (ranges represent differences in severity and extent): normal mucosa 1, non-atrophic gastritis 2, multifocal atrophic gastritis without intestinal metaplasia 3.25-4.0, gastric intestinal metaplasia 4.3-5.0, dysplasia 5.25-5.75, and cancer 6. The Correa Histopathology Score is based upon the Updated Sydney System biopsy protocol (5 biopsies). The most advanced lesion (highest Correa score) in the stomach represents the summary Correa score for the patient at the given time point.
Measured: Baseline up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2016 (estimated)
- Study start19 Sep 2016
- Primary completion20 Dec 2022
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Cancer Prevention Pharmaceuticals, Inc.
- Responsible party
- Principal investigator, Douglas Morgan, Vanderbilt-Ingram Cancer Center
- Investigators
- Doug Morgan, MD, Study chair, Vanderbilt University Medical Center, Vanderbilt-Ingram Cancer enterKeith Wilson, MD, Principal investigator, Vanderbilt University Medical Center, Vanderbilt-Ingram Cancer enter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02794428
- Sponsor's protocol ID
- VICC GI 1527
- Other IDs
- 6R01CA190612-03
- Status last verified
- Aug 2026
- First submitted
- 20 May 2016
- Last updated
- 2 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Morgan DR, Dominguez RL, Norwood DA, Montalvan-Sanchez EE, Piazuelo MB, Rodriguez-Murillo A, Delgado AG, Hernandez-Marrero J, Gonzalez-Pons M, Beasley TM, Cruz-Correa M, Wilson KT. Safety and Efficacy of Eflornithine in Patients with Gastric Precancerous Lesions: A Double-Blinded, Randomized Clinical Trial. Cancer Prev Res (Phila). 2026 Jul 1;19(7):391-402. doi: 10.1158/1940-6207.CAPR-25-0364.
PubMed 41801147
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Chemoprevention of Gastric Carcinogenesis in High Risk Populations
- ClinicalTrials.gov ID
- NCT02794428
- Acronym / sponsor ID
- VICC GI 1527
- Conditions
- Gastric Cancer, Gastric Intestinal Metaplasia
- Keywords
- Gastric adenocarcinoma, Gastric intestinal metaplasia, Atrophic gastritis, Gastric premalignant lesion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Cancer Prevention Pharmaceuticals, Inc.
- Study start
- 19 Sep 2016 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 9 Jun 2016 (estimated)
- Results
- Posted 5 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A clinical study of the efficacy of oral alpha-difluoromethylornithine (eflornithine or DFMO) in male and female subjects ages 30-60 with gastric premalignant lesions in two high risk regions of Latin America.
Detailed description
Primary Objective
- The difference in cell DNA damage between patients treated with DFMO and patients treated with placebo at 6 months. The cell DNA damage is measured using the percent positive gastric epithelial cells assessed by IHC for gamma H2AX. The mean difference between the two groups at 6 months will be calculated, accounting for their baseline measurements.
Secondary Objectives
- The difference in cell DNA damage between patients treated with DFMO and patients treated with placebo for 18 months, and then followed for an additional 6 months. The cell DNA damage is measured using the percent positive gastric epithelial cells assessed by IHC for gamma H2AX. The mean difference between the two groups at 18 and 24 months will be calculated, accounting for their baseline measurements.
- The differences in the gastritis histopathology score between patients treated with DFMO and patients treated with placebo for a total of 18 months, and followed for an additional 6 months. The gastritis histopathology score is measured with a quantitative scale 0.0-6.0, for atrophy, intestinal metaplasia, and dysplasia. The mean differences between the two groups at 6, 18, and 24 months will be calculated using mixed models, accounting for their baseline measurements.
- Number of patients with quantitative toxicities. Toxicities will be assessed per CTCAE criteria, and each toxicity will be assigned an adverse event (AE) term according to CTCAE definitions (each AE term = unique representation of a specific event used for medical documentation and scientific analyses), and graded as defined by CTCAE (grade 1 = mild; grade 2 = moderate; grade 3 = severe or significant but not immediately life-threatening; grade 4 = life-threatening; grade 5 = death).
- To evaluate whether candidate single nucleotide polymorphisms (SNPs) relevant to eflornithine (DFMO) efficacy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eflornithine | Active comparator | Drug: Eflornithine |
| Eflornithine Placebo | Placebo comparator | Other: Eflornithine placebo |
Who may qualify
- Ages
- 30 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients must have a history of a premalignant lesion of the stomach, atrophic gastritis or intestinal metaplasia
- Patients must have a pure tone audiometry evaluation to document air conduction within 60 days prior to randomization.
- Patients must have adequate blood counts as evidenced by the following results (obtained within 60 days):
Key exclusion criteria (10 listed)
- Subjects with dysplasia (indeterminate, low grade, high grade) are not eligible for participation
- Patients must not have a significant medical or psychiatric condition that would preclude study completion.
- Patients with hearing loss ≥30 dB in any of the tested frequencies (250 Hz, 500 Hz, 1,000 Hz, 2,000 Hz, 4,000 Hz, 8,000 Hz) are not eligible.
- Patients must not have known hypersensitivity to eflornithine or the excipients.
- Patients must not be receiving corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), or anticoagulants on a regular or intermittent basis.
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 |
|---|---|---|
| EflornithineEflornithine*, 2 tablets, Oral, Daily for 18 months | Drug | Eflornithine |
| Eflornithine placeboEflornithine placebo, 2 tablets, Oral, Daily for 18 months | Other | Eflornithine Placebo |
Primary outcome
Gastric Epithelial Cell DNA Damage, at 6 Months Versus Baseline
Time frame: Baseline up to 6 months
The cell DNA damage is measured by the percent positive gastric epithelial cells, as assessed by IHC for gamma H2AX. The mean differences at 6 months versus baseline of the percent positive gastric epithelial cells is compared between the two groups.
5 secondary outcomes
Gastric Epithelial Cell DNA Damage, at 18 Months Versus Baseline
Time frame: Baseline up to 18 months
Gastric Epithelial Cell DNA Damage, at 24 Months Versus Baseline
Time frame: Baseline up to 24 months
Change in Gastric Histopathology Score, at 6 Months Versus Baseline
Time frame: Baseline up to 6 months
Change in Gastric Histology Score, at 18 Months Versus Baseline
Time frame: Baseline up to 18 months
Change in Gastric Histology Score, at 24 Months Versus Baseline
Time frame: Baseline up to 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 41801147Morgan DR, Dominguez RL, Norwood DA, Montalvan-Sanchez EE, Piazuelo MB, Rodriguez-Murillo A, Delgado AG, Hernandez-Marrero J, Gonzalez-Pons M, Beasley TM, Cruz-Correa M, Wilson KT. Safety and Efficacy of Eflornithine in Patients with Gastric Precancerous Lesions: A Double-Blinded, Randomized Clinical Trial. Cancer Prev Res (Phila). 2026 Jul 1;19(7):391-402. doi: 10.1158/1940-6207.CAPR-25-0364.
- Vanderbilt-Ingram Cancer Center, Find a Clinical TrialLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Doug Morgan, MD study chair
Vanderbilt University Medical Center, Vanderbilt-Ingram Cancer enter
Keith Wilson, MD principal investigator
Vanderbilt University Medical Center, Vanderbilt-Ingram Cancer enter
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Eflornithine in people with Gastric Cancer and Gastric Intestinal Metaplasia, run by Vanderbilt-Ingram Cancer Center at 2 sites in 2 countries.
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 6 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: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Honduras, Puerto Rico. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 5 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric Epithelial Cell DNA Damage, at 6 Months Versus Baseline (time frame: Baseline up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02794428, which also lists 1 linked publication.
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 2 Sep 2026.