NCT02794428CompletedPhase 2
Chemoprevention of Gastric Carcinogenesis
Targeted Chemoprevention of Gastric Carcinogenesis in High Risk Populations
Source: ClinicalTrials.gov · Last updated 2 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 91 (actual)
- First submitted
- 20 May 2016
- Start date
- 19 Sept 2016
- Primary completion date
- 20 Dec 2022
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT02794428
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 91
- From 19 Sept 2016 to the primary completion date, 20 Dec 2022
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients must not be receiving corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), or anticoagulants on a regular or intermittent basis.
- Patients must not be receiving corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), or anticoagulants on a regular or intermittent basis.
Other illness
- Patients must not have a significant medical or psychiatric condition that would preclude study completion.
- Patients must not have known hypersensitivity to eflornithine or the excipients.
- 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).
- 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.
Age
- 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.
Other
- Subjects with dysplasia (indeterminate, low grade, high grade) are not eligible for participation
- 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 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.
Who the study is looking for
- 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
Age in the registry: 30 years to 69 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ministry of Health, Hospital de Occidente Coordinator of this site? Confirm its status | Copán | Honduras | Unknown status |
| University of Puerto Rico, Comprehensive Cancer Center Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
Related publications
- Safety and Efficacy of Eflornithine in Patients with Gastric Precancerous Lesions: A Double-Blinded, Randomized Clinical Trial.Cancer Prev Res (Phila) · 2026 · PMID 41801147
This page is information, not medical advice. Discuss any trial with your doctor.