Using low-dose aspirin to prevent gastric cancer in early gastric cancer patients
Effect of Low-dose Aspirin for Stomach Cancer Prevention After Endoscopic Resection of Gastric Neoplasm (EASTERN): a Randomized Controlled Trial
This study is testing if low-dose aspirin can help prevent gastric cancer in patients who have had early gastric cancer removed and are free of H. pylori infection.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1700 (estimated) |
| Ages | 19 Years to 70 Years |
| Sex | All |
| Sponsor | National Cancer Center, Korea Government |
| Locations | 10 sites (Busan and 9 other locations) |
| Trial ID | NCT04214990 on ClinicalTrials.gov |
What this trial studies
This study investigates the effect of low-dose aspirin (100 mg) on preventing gastric cancer in patients who have undergone endoscopic submucosal dissection for early gastric cancer and have a negative H. pylori status. The trial is designed as a multi-center, double-blind, placebo-controlled intervention to assess the long-term cancer prevention effects of aspirin. It aims to address the limitations of previous studies by focusing specifically on gastric cancer prevention rather than cardiovascular outcomes. Participants will be monitored for the development of metachronous gastric cancer following their treatment.
Who should consider this trial
Good fit: Ideal candidates are men and women aged 19-70 who have undergone endoscopic resection for early gastric cancer and have a negative H. pylori status.
Not a fit: Patients with a history of regular aspirin use for cardiovascular disease prevention or those with prior gastrectomy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new preventive strategy for gastric cancer in at-risk patients.
How similar studies have performed: Previous studies have suggested a potential benefit of aspirin in reducing gastrointestinal cancer risks, but this specific approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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%
Where this trial is running
Busan and 9 other locations
- Pusan National University Hospital — Busan, South Korea (Recruiting)
- Kosin University Gospel Hospital — Busan, South Korea (Recruiting)
- Hallym University Chuncheon Sacred Heart Hospital — Chuncheon, South Korea (Recruiting)
- Kyungpook National University Chilgok Hospital — Daegu, South Korea (Recruiting)
- National Cancer Center — Goyang, South Korea (Recruiting)
- Chonnam National University Hospital — Gwangju, South Korea (Recruiting)
- Incheon St.Mary's Hospital/The Catholic University — Incheon, South Korea (Recruiting)
- Chung-Ang University Hospital — Seoul, South Korea (Recruiting)
- SMG-SNU Boramae Medical Center — Seoul, South Korea (Recruiting)
- Asan Medical Center — Seoul, South Korea (Not_yet_recruiting)
Study contacts
- Study coordinator: Il Ju Choi, M.D., Ph.D.
- Email: cij1224@ncc.re.kr
- Phone: +82-31-920-2282
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.