Aspirin Use for Gastric Cancer Prevention in the Early Gastric Cancer Patients

Launched by NATIONAL CANCER CENTER, KOREA · Dec 29, 2019

Keywords

ClinConnect Summary

This clinical trial is studying whether low-dose aspirin (100 mg) can help prevent gastric cancer in patients who have already been treated for early gastric cancer and have tested negative for H. pylori, a bacteria linked to stomach issues. The goal is to see if taking aspirin can reduce the risk of cancer returning after a procedure called endoscopic submucosal dissection, which is a method used to remove early-stage cancers from the stomach.

To participate in this study, you need to be between 19 and 70 years old and have had a specific type of stomach cancer or high-grade adenoma removed. You also must have tested negative for H. pylori or have successfully treated it. However, if you have certain health conditions, are currently taking aspirin for other reasons, or have had major surgeries on your stomach, you may not be eligible. If you join the trial, you'll be asked to take aspirin for a period and will be monitored closely to see how well it works in preventing cancer from coming back.

Gender

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Eligibility 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%