Clinical trial NCT04214990: Aspirin Use for Gastric Cancer Prevention in the Early Gastric Cancer Patients
Official title: Effect of Low-dose Aspirin for Stomach Cancer Prevention After Endoscopic Resection of Gastric Neoplasm (EASTERN): a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Aspirin
Gastric Cancer
Keywords: Aspirin
Gastric cancer prevention
Endoscopic submucosal dissection
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
Collaborators: name: Incheon St.Mary's Hospital/The Catholic University
name: Kosin University Gospel Hospital
name: Pusan National University Hospital
name: SMG-SNU Boramae Medical Center
name: Chonnam National University Hospital
name: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
name: Chilgok Kyungpook National University
name: Hallym University Medical Center
name: Asan Medical Center
name: Seoul National University Bundang Hospital
name: Severance Hospital
name: Samsung Medical Center
First posted: 2020-01-02
Enrollment: 1700
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

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%

Primary outcomes:
measure: The incidence of gastric cancer between the intervention and placebo groups
timeFrame: Until last enrolled patients take 5-year trial medication
Secondary outcomes:
measure: All-cause mortality
timeFrame: Until last enrolled patients take 5-year trial medication
measure: The incidence of cardiovascular disease and cerebrovascular disease between the intervention and placebo groups
timeFrame: Until last enrolled patients take 5-year trial medication
measure: The incidence of other organ cancers between the intervention and placebo groups
timeFrame: Until last enrolled patients take 5-year trial medication
measure: The incidence of gastric dysplasia (adenoma) between the intervention and placebo groups
timeFrame: Until last enrolled patients take 5-year trial medication
measure: Complication related to the aspirin use
timeFrame: Until last enrolled patients take 5-year trial medication
measure: Improvement of atrophy and intestinal metaplasia
timeFrame: At the time of 5-year trial medication
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
city: Chuncheon
country: Korea, Republic of
facility: Hallym University Chuncheon Sacred Heart Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
city: Goyang
country: Korea, Republic of
facility: National Cancer Center
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Incheon
country: Korea, Republic of
facility: Incheon St.Mary's Hospital/The Catholic University
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: National Cancer Center, Korea
name: Il Ju Choi, M.D., Ph.D.
role: STUDY_DIRECTOR
References: