Aspirin Use for Gastric Cancer Prevention in the Early Gastric Cancer Patients
- Conditions
- Gastric CancerAspirin
- Interventions
- Drug: Placebo oral tablet
- Registration Number
- NCT04214990
- Lead Sponsor
- National Cancer Center, Korea
- Brief 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.
- Detailed Description
Aspirin has been widely used as an anti-platelet drug for the primary or secondary prevention of cardiovascular events, including ischemic heart disease and stroke. In 2016, the U.S. Preventive Services Task Force recommended initiating low-dose aspirin use for the primary prevention of cardiovascular diseases and colorectal cancer in adult aged 50 to 59 years who have a 10% or greater 10-year cardiovascular disease risk, are not at increased risk of bleeding, have a life expectancy of at least 10 years, and are willing to take low-dose aspirin daily for at least 10 years. In addition, a meta-analysis reported that long-term aspirin use was associated with reduced the risk of gastrointestinal cancers including colorectal cancer, esophageal cancer, and gastric cancer. However, most studies that reported the cancer prevention effect of long-term aspirin use were conducted as a secondary analysis or subgroup analysis of primary studies investigating the aspirin use for cardiovascular disease prevention. Thus, there is a limitation that appropriate sample sizes and follow-up periods for the cancer prevention effect of aspirin were not considered.
In 2018, we reported that H. pylori treatment reduced the development of metachronous gastric cancer after endoscopic resection in early gastric cancer patients. However, metachronous gastric cancer could develop after successful H. pylori eradication with an annual incidence of 1%-3%. Therefore, we designed a multi-center, double-blind, randomized, placebo-controlled trial to evaluate whether long-term low-dose (100 mg) aspirin uses prevents gastric cancer in early gastric cancer or high-grade dysplasia patients who underwent endoscopic resection.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1700
- 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
- 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%
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Aspirin Aspirin 100mg Enteric coated aspirin Placebo Placebo oral tablet Enteric coated aspirin placebo
- Primary Outcome Measures
Name Time Method The incidence of gastric cancer between the intervention and placebo groups Until last enrolled patients take 5-year trial medication Histologically confirmed gastric cancer detected at follow-up endoscopy or registered at the Korean Cancer Registry
- Secondary Outcome Measures
Name Time Method The incidence of gastric dysplasia (adenoma) between the intervention and placebo groups Until last enrolled patients take 5-year trial medication Histologically confirmed gastric dysplasia (adenoma) detected at follow-up endoscopy
All-cause mortality Until last enrolled patients take 5-year trial medication Mortality from any causes
The incidence of cardiovascular disease and cerebrovascular disease between the intervention and placebo groups Until last enrolled patients take 5-year trial medication Cardiovascular diseases (stable and unstable angina, myocardial infarction); Cerebrovascular diseases (transient ischemic attack, cerebral infarction, other small vascular infarction, etc)
Complication related to the aspirin use Until last enrolled patients take 5-year trial medication Gastrointestinal bleeding, intracranial hemorrhage, subarachnoid hemorrhage, and other bleeding complications
The incidence of other organ cancers between the intervention and placebo groups Until last enrolled patients take 5-year trial medication Cancers detected at follow-up visits or registered at the Korean Cancer Registry
Improvement of atrophy and intestinal metaplasia At the time of 5-year trial medication Change in histologic atrophy and intestinal metaplasia grades from enrollment to subsequent endoscopic assessment
Trial Locations
- Locations (10)
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Kosin University Gospel Hospital
🇰🇷Busan, Korea, Republic of
Hallym University Chuncheon Sacred Heart Hospital
🇰🇷Chuncheon, Korea, Republic of
Kyungpook National University Chilgok Hospital
🇰🇷Daegu, Korea, Republic of
National Cancer Center
🇰🇷Goyang, Korea, Republic of
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
Incheon St.Mary's Hospital/The Catholic University
🇰🇷Incheon, Korea, Republic of
Chung-Ang University Hospital
🇰🇷Seoul, Korea, Republic of
SMG-SNU Boramae Medical Center
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of