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

Last updated: December 25, 2024
Sponsor: National Cancer Center, Korea
Overall Status: Active - Recruiting

Phase

3

Condition

Stomach Cancer

Gastric Cancer

Digestive System Neoplasms

Treatment

Placebo oral tablet

Aspirin 100mg

Clinical Study ID

NCT04214990
NCC2019-0184
  • Ages 19-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Men and women aged 19-70 years who underwent endoscopic resection for high-gradeadenoma or early gastric cancer (category 4 [non-invasive high grade neoplasm] orcategory 5 [invasive neoplasia] according to the Vienna classification ofgastrointestinal epithelial neoplasia [Schlemper RJ, et al. Gut 2000;47:251-255.])

  • Final pathological results after endoscopic resection met the absolute or expandedcriteria according to the Japanese Gastric Cancer Treatment guideline 2014 (version

  • Patients who had negative H. pylori status or those who eradicated H. pylori status

  • Willingness to sign an informed consent form

Exclusion

Exclusion Criteria:

  • Patients who received aspirin for the secondary prevention of cardiovasculardiseases 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 bronchialasthma, or uncontrolled infection)

  • High risk patients for bleeding complications (cerebral aneurysm, vascularmalformation, esophageal or gastric varices, or hemophilia, etc)

  • Active peptic ulcer disease (patients who treated peptic ulcer completely could beenrolled)

  • Diagnosis and active treatment for other organ cancer (except carcinoma in situ, andnon-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 studyphysician

  • Inability to provide an informed consent

  • Patients who took a 28-day run-in-period medication less than 80%

Study Design

Total Participants: 1700
Treatment Group(s): 2
Primary Treatment: Placebo oral tablet
Phase: 3
Study Start date:
February 15, 2020
Estimated Completion Date:
March 31, 2032

Study 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.

Connect with a study center

  • Kosin University Gospel Hospital

    Busan, 49267
    Korea, Republic of

    Active - Recruiting

  • Pusan National University Hospital

    Busan, 49241
    Korea, Republic of

    Active - Recruiting

  • Hallym University Chuncheon Sacred Heart Hospital

    Chuncheon, 24253
    Korea, Republic of

    Active - Recruiting

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404
    Korea, Republic of

    Active - Recruiting

  • National Cancer Center

    Goyang, 10408
    Korea, Republic of

    Active - Recruiting

  • National Cancer Center

    Goyang-si, 10408
    Korea, Republic of

    Site Not Available

  • Chonnam National University Hospital

    Gwangju, 61469
    Korea, Republic of

    Active - Recruiting

  • Incheon St.Mary's Hospital/The Catholic University

    Incheon, 21431
    Korea, Republic of

    Active - Recruiting

  • Asan Medical Center

    Seoul,
    Korea, Republic of

    Site Not Available

  • Chung-Ang University Hospital

    Seoul, 06973
    Korea, Republic of

    Active - Recruiting

  • SMG-SNU Boramae Medical Center

    Seoul, 07061
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

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