Aspirin Use for Gastric Cancer Prevention in the Early Gastric Cancer Patients (EASTERN)

November 7, 2023 updated by: Il Ju Choi, National Cancer Center, Korea

Effect of Low-dose Aspirin for Stomach Cancer Prevention After Endoscopic Resection of Gastric Neoplasm (EASTERN): a Randomized Controlled 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

1700

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Il Ju Choi, M.D., Ph.D.
  • Phone Number: +82-31-920-2282
  • Email: cij1224@ncc.re.kr

Study Contact Backup

  • Name: Young-Il Kim, MD
  • Phone Number: +82-31-920-1712
  • Email: 11996@ncc.re.kr

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 49241
        • Recruiting
        • Pusan National University Hospital
        • Contact:
        • Principal Investigator:
          • Gwang Ha Kim, M.D., Ph.D.
      • Busan, Korea, Republic of, 49267
        • Recruiting
        • Kosin University Gospel Hospital
        • Contact:
        • Principal Investigator:
          • Moo In Park, M.D., Ph.D.
      • Chuncheon, Korea, Republic of, 24253
        • Recruiting
        • Hallym University Chuncheon Sacred Heart Hospital
        • Contact:
        • Principal Investigator:
          • Gwang Ho Baik, M.D.
      • Daegu, Korea, Republic of, 41404
        • Recruiting
        • Kyungpook National University Chilgok Hospital
        • Contact:
        • Principal Investigator:
          • Seong Woo Jeon, M.D., Ph.D.
      • Goyang, Korea, Republic of, 10408
        • Recruiting
        • National Cancer Center
        • Contact:
        • Principal Investigator:
          • Il Ju Choi, M.D., Ph.D.
      • Gwangju, Korea, Republic of, 61469
        • Recruiting
        • Chonnam National University Hospital
        • Contact:
        • Principal Investigator:
          • Seon-Young Park, M.D., Ph.D.
      • Incheon, Korea, Republic of, 21431
        • Recruiting
        • Incheon St.Mary's Hospital/The Catholic University
        • Contact:
        • Principal Investigator:
          • Byung-Wook Kim, M.D.,Ph.D.
      • Seoul, Korea, Republic of, 06973
        • Recruiting
        • Chung-Ang University Hospital
        • Contact:
        • Principal Investigator:
          • Jae Gyu Kim, M.D., Ph.D.
      • Seoul, Korea, Republic of
        • Not yet recruiting
        • Asan Medical Center
        • Contact:
      • Seoul, Korea, Republic of
        • Not yet recruiting
        • Seoul National University Hospital
        • Contact:
      • Seoul, Korea, Republic of, 07061
        • Recruiting
        • SMG-SNU Boramae Medical Center
        • Contact:
        • Principal Investigator:
          • Ji Won Kim, M.D., Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Aspirin
Enteric coated aspirin
Drug: Aspirin 100mg
Daily aspirin 100 mg for 5 years
Placebo Comparator: Placebo
Enteric coated aspirin placebo
Drug: Placebo oral tablet
Daily placebo for 5 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of gastric cancer between the intervention and placebo groups
Time Frame: 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
Until last enrolled patients take 5-year trial medication

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: Until last enrolled patients take 5-year trial medication
Mortality from any causes
Until last enrolled patients take 5-year trial medication
The incidence of cardiovascular disease and cerebrovascular disease between the intervention and placebo groups
Time Frame: 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)
Until last enrolled patients take 5-year trial medication
The incidence of other organ cancers between the intervention and placebo groups
Time Frame: Until last enrolled patients take 5-year trial medication
Cancers detected at follow-up visits or registered at the Korean Cancer Registry
Until last enrolled patients take 5-year trial medication
The incidence of gastric dysplasia (adenoma) between the intervention and placebo groups
Time Frame: Until last enrolled patients take 5-year trial medication
Histologically confirmed gastric dysplasia (adenoma) detected at follow-up endoscopy
Until last enrolled patients take 5-year trial medication
Complication related to the aspirin use
Time Frame: Until last enrolled patients take 5-year trial medication
Gastrointestinal bleeding, intracranial hemorrhage, subarachnoid hemorrhage, and other bleeding complications
Until last enrolled patients take 5-year trial medication
Improvement of atrophy and intestinal metaplasia
Time Frame: At the time of 5-year trial medication
Change in histologic atrophy and intestinal metaplasia grades from enrollment to subsequent endoscopic assessment
At the time of 5-year trial medication

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Center, Korea

Collaborators

Pusan National University Hospital
Asan Medical Center
Chonnam National University Hospital
Seoul National University Hospital
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
SMG-SNU Boramae Medical Center
Hallym University Medical Center
Kosin University Gospel Hospital
Incheon St.Mary's Hospital/The Catholic University
Chilgok Kyungpook National University

Investigators

  • Study Director: Il Ju Choi, M.D., Ph.D., National Cancer Center, Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2020

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

December 29, 2019

First Submitted That Met QC Criteria

December 29, 2019

First Posted (Actual)

January 2, 2020

Study Record Updates

Last Update Posted (Estimated)

November 9, 2023

Last Update Submitted That Met QC Criteria

November 7, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCC2019-0184

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gastric Cancer

Clinical Trials on Aspirin 100mg

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lebanon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe