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

Gastric Cancer Clinical Trial

— EASTERN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04214990
• Other study ID #: NCC2019-0184
• Status: Recruiting
• Phase: Phase 3
• Start date: February 15, 2020
• Est. completion date: December 31, 2028

Study information

• Verified date: November 2023
• Source: National Cancer Center, Korea
• Contact: Il Ju Choi, M.D., Ph.D.
• Phone: +82-31-920-2282
• Email: cij1224[@]ncc.re.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 1700
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

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%

Related Conditions & MeSH terms

• Aspirin
• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Aspirin 100mg
Daily aspirin 100 mg for 5 years
• Placebo oral tablet
Daily placebo for 5 years

Locations

Country	Name	City	State
Korea, Republic of	Kosin University Gospel Hospital	Busan
Korea, Republic of	Pusan National University 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	Asan Medical Center	Seoul
Korea, Republic of	Chung-Ang University Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	SMG-SNU Boramae Medical Center	Seoul

Sponsors (11)

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

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Until last enrolled patients take 5-year trial medication
Secondary	All-cause mortality	Mortality from any causes	Until last enrolled patients take 5-year trial medication
Secondary	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)	Until last enrolled patients take 5-year trial medication
Secondary	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	Until last enrolled patients take 5-year trial medication
Secondary	The incidence of gastric dysplasia (adenoma) between the intervention and placebo groups	Histologically confirmed gastric dysplasia (adenoma) detected at follow-up endoscopy	Until last enrolled patients take 5-year trial medication
Secondary	Complication related to the aspirin use	Gastrointestinal bleeding, intracranial hemorrhage, subarachnoid hemorrhage, and other bleeding complications	Until last enrolled patients take 5-year trial medication
Secondary	Improvement of atrophy and intestinal metaplasia	Change in histologic atrophy and intestinal metaplasia grades from enrollment to subsequent endoscopic assessment	At the time of 5-year trial medication