Actively Recruiting
Effect of Low-dose Aspirin for Stomach Cancer Prevention After Endoscopic Resection of Gastric Neoplasm EASTERN a Randomized Controlled Trial
Led by National Cancer Center, Korea · Updated on 2024-12-27
1700
Participants Needed
10
Research Sites
52 weeks
Total Duration
On this page
Sponsors
N
National Cancer Center, Korea
Lead Sponsor
I
Incheon St.Mary's Hospital/The Catholic University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of low-dose aspirin 100 mg daily on preventing gastric cancer in patients with early gastric cancer or high-grade adenoma who have undergone endoscopic resection and have a negative or eradicated Helicobacter pylori status. This randomized, placebo-controlled Phase 3 trial addresses limitations in previous studies by focusing specifically on gastric cancer prevention with appropriate sample size and follow-up. Aspirin is commonly used to reduce cardiovascular risks, and some evidence suggests it may also lower gastrointestinal cancer risk, but more targeted research is needed. Participants will be randomly assigned to receive either enteric-coated aspirin 100 mg daily or a placebo tablet for five years. This double-blind study compares the incidence of gastric cancer between the aspirin and placebo groups. The trial includes a treatment period of five years, during which participants take the assigned medication daily. The study also monitors secondary outcomes like mortality, cardiovascular events, occurrence of other cancers, gastric dysplasia, aspirin-related complications, and gastric tissue improvements. During the study, participants will undergo regular assessments including pathology reviews after endoscopic resection and monitoring for adverse events. Researchers will track the primary outcome of gastric cancer incidence throughout the treatment period. Secondary outcomes such as cardiovascular disease rates and overall survival will also be evaluated. The total participant involvement includes screening, a five-year medication period, and ongoing monitoring to assess treatment effects and safety.
CONDITIONS
Brief Title
Aspirin Use for Gastric Cancer Prevention in the Early Gastric Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 19 to 70 years
- Underwent endoscopic resection for high-grade adenoma or early gastric cancer
- Final pathology meets the Japanese Gastric Cancer Treatment guideline absolute or expanded criteria
- Negative Helicobacter pylori status or successful eradication
- Willing to sign informed consent
You will not qualify if you...
- Use of aspirin for secondary prevention of cardiovascular or cerebrovascular diseases
- Regular aspirin use more than 3 times a week within 2 months before screening
- Use of anticoagulants or antiplatelet drugs for treatment
- History of gastrectomy
- Serious medical conditions hindering participation (severe heart dysfunction, liver cirrhosis, renal failure, COPD, bronchial asthma, uncontrolled infection)
- High risk for bleeding complications (cerebral aneurysm, vascular malformation, esophageal or gastric varices, hemophilia)
- Active peptic ulcer disease (unless fully treated)
- Diagnosis and active treatment for other organ cancer within 5 years (except carcinoma in situ and non-melanoma skin cancer)
- Non-curative resection after endoscopic resection
- Allergy or contraindication to aspirin
- Pregnant or lactating women
- Alcoholism or drug abuse
- Inadequate for study enrollment per physician evaluation
- Unable to provide informed consent
- Took less than 80% of run-in-period medication in 28 days prior to screening
Research Team
I
Il Ju Choi, M.D., Ph.D.
Y
Young-Il Kim, MD
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