Aspirin Use for Gastric Cancer Prevention in the Early Gastric Cancer Patients
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age19-70
SponsorNational Cancer Center, Korea
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Aspirin 100mg
DrugDaily aspirin 100 mg for 5 years
Placebo oral tablet
DrugDaily placebo for 5 years
Treatment groups
1,700 Participants
are divided into 2 treatment groupsGroup A: AspirinActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
The incidence of gastric cancer between the intervention and placebo groups
Histologically confirmed gastric cancer detected at follow-up endoscopy or registered at the Korean Cancer Registry
Time frame
Until last enrolled patients take 5-year trial medicationSecondary outcomes
1
All-cause mortality
Mortality from any causes
Time frame
Until last enrolled patients take 5-year trial medication2
The incidence of cardiovascular disease and cerebrovascular disease between the intervention and placebo groups
Cardiovascular diseases (stable and unstable angina, myocardial infarction); Cerebrovascular diseases (transient ischemic attack, cerebral infarction, other small vascular infarction, etc)
Time frame
Until last enrolled patients take 5-year trial medication3
The incidence of other organ cancers between the intervention and placebo groups
Cancers detected at follow-up visits or registered at the Korean Cancer Registry
Time frame
Until last enrolled patients take 5-year trial medication4
The incidence of gastric dysplasia (adenoma) between the intervention and placebo groups
Histologically confirmed gastric dysplasia (adenoma) detected at follow-up endoscopy
Time frame
Until last enrolled patients take 5-year trial medicationSponsors and contacts
Click on the lead sponsor to view all of their trials.
National Cancer Center, Korea
Lead sponsor
Incheon St.Mary's Hospital/The Catholic University
Collaborator
Kosin University Gospel Hospital
Collaborator
Pusan National University Hospital
Collaborator
SMG-SNU Boramae Medical Center
Collaborator
Chonnam National University Hospital
Collaborator
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Collaborator
Chilgok Kyungpook National University
Collaborator
Hallym University Medical Center
Collaborator
Asan Medical Center
Collaborator
Seoul National University Bundang Hospital
Collaborator
Severance Hospital
Collaborator
Samsung Medical Center
Collaborator
Source ClinicalTrials.gov