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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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15 April 2024 |
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Main ID: |
NCT02794428 |
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Date of registration:
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20/05/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Chemoprevention of Gastric Carcinogenesis
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Scientific title:
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Targeted Chemoprevention of Gastric Carcinogenesis in High Risk Populations |
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Date of first enrolment:
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September 19, 2016 |
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Target sample size:
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91 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02794428 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator).
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Phase:
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Phase 2
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Countries of recruitment
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Colombia
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Honduras
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Puerto Rico
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Contacts
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Name:
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Doug Morgan, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Vanderbilt University Medical Center, Vanderbilt-Ingram Cancer enter |
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Name:
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Keith Wilson, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Vanderbilt University Medical Center, Vanderbilt-Ingram Cancer enter |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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
Exclusion Criteria:
- 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).
- 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.
Age minimum:
30 Years
Age maximum:
69 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Gastric Cancer
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Gastric Intestinal Metaplasia
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Intervention(s)
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Drug: Eflornithine
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Other: Eflornithine placebo
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Primary Outcome(s)
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The Difference in Cell DNA Damage, Based on Percent Positive Cells, Between Patients Treated With DFMO and Patients Treated With Placebo at 6 Months.
[Time Frame: at 6 months]
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Secondary Outcome(s)
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Number of Patients With Quantitative Toxicities.
[Time Frame: at 6, 18, and 24 months]
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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.
[Time Frame: at 6, 18 and 24 months]
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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.
[Time Frame: at 18 and 24 months]
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Secondary ID(s)
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6R01CA190612-03
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VICC GI 1527
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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