RecruitingPhase 3NCT04214990
Aspirin Use for Gastric Cancer Prevention in the Early Gastric Cancer Patients
Effect of Low-dose Aspirin for Stomach Cancer Prevention After Endoscopic Resection of Gastric Neoplasm (EASTERN): a Randomized Controlled Trial
Sponsor
National Cancer Center, Korea
Enrollment
1,700 participants
Start Date
Feb 15, 2020
Study Type
INTERVENTIONAL
Conditions
Summary
This study aimed to investigate the effect of low-dose (100 mg) asprin on the prevention of gastric cancer in the early gastric cancer patients with negative H. pylori status who underwent endoscopic submucosal dissection.
Eligibility
Min Age: 19 YearsMax Age: 70 Years
Inclusion Criteria4
- Men and women aged 19-70 years who underwent endoscopic resection for high-grade adenoma or early gastric cancer (category 4 \[non-invasive high grade neoplasm\] or category 5 \[invasive neoplasia\] according to the Vienna classification of gastrointestinal epithelial neoplasia \[Schlemper RJ, et al. Gut 2000;47:251-255.\])
- Final pathological results after endoscopic resection met the absolute or expanded criteria according to the Japanese Gastric Cancer Treatment guideline 2014 (version 4)
- Patients who had negative H. pylori status or those who eradicated H. pylori status
- Willingness to sign an informed consent form
Exclusion Criteria15
- Patients who received aspirin for the secondary prevention of cardiovascular diseases or cerebrovascular diseases
- Regular aspirin uses (more than 3 times a week) with 2 months before screening visit
- Patients who used anticoagulants or antiplatelet drugs for therapeutic purpose
- Previous gastrectomy history
- Current treatment for serious medical condition which could hinder participation (such as severe heart dysfunction, liver cirrhosis, renal failure, COPD or bronchial asthma, or uncontrolled infection)
- High risk patients for bleeding complications (cerebral aneurysm, vascular malformation, esophageal or gastric varices, or hemophilia, etc)
- Active peptic ulcer disease (patients who treated peptic ulcer completely could be enrolled)
- Diagnosis and active treatment for other organ cancer (except carcinoma in situ, and non-melanoma skin cancer) within 5 years
- Non-curative resection of early gastric cancer after endoscopic resection
- Aspirin allergy or contraindication of aspirin use
- Pregnant or lactating women
- Alcoholism, drug abuse
- Inadequate patients for study enrollment according to the evaluation of the study physician
- Inability to provide an informed consent
- Patients who took a 28-day run-in-period medication less than 80%
Interventions
DRUGAspirin 100mg
Daily aspirin 100 mg for 5 years
DRUGPlacebo oral tablet
Daily placebo for 5 years
Locations(10)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04214990
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