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

Primary Purpose

Aspirin, Gastric Cancer

Status
Recruiting
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Aspirin 100mg
Placebo oral tablet
Sponsored by
National Cancer Center, Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Aspirin focused on measuring Aspirin, Gastric cancer prevention, Endoscopic submucosal dissection

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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%

Sites / Locations

  • Pusan National University HospitalRecruiting
  • Kosin University Gospel HospitalRecruiting
  • Hallym University Chuncheon Sacred Heart HospitalRecruiting
  • Kyungpook National University Chilgok HospitalRecruiting
  • National Cancer CenterRecruiting
  • Chonnam National University HospitalRecruiting
  • Incheon St.Mary's Hospital/The Catholic UniversityRecruiting
  • Chung-Ang University HospitalRecruiting
  • SMG-SNU Boramae Medical CenterRecruiting
  • Asan Medical Center
  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Aspirin

Placebo

Arm Description

Enteric coated aspirin

Enteric coated aspirin placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

All-cause mortality
Mortality from any causes
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)
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
The incidence of gastric dysplasia (adenoma) between the intervention and placebo groups
Histologically confirmed gastric dysplasia (adenoma) detected at follow-up endoscopy
Complication related to the aspirin use
Gastrointestinal bleeding, intracranial hemorrhage, subarachnoid hemorrhage, and other bleeding complications
Improvement of atrophy and intestinal metaplasia
Change in histologic atrophy and intestinal metaplasia grades from enrollment to subsequent endoscopic assessment

Full Information

First Posted
December 29, 2019
Last Updated
May 11, 2021
Sponsor
National Cancer Center, Korea
Collaborators
Incheon St.Mary's Hospital/The Catholic University, Kosin University Gospel Hospital, Pusan National University Hospital, SMG-SNU Boramae Medical Center, Chonnam National University Hospital, Chung-Ang University Hosptial, Chung-Ang University College of Medicine, Chilgok Kyungpook National University, Hallym University Medical Center, Seoul National University Hospital, Asan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04214990
Brief Title
Aspirin Use for Gastric Cancer Prevention in the Early Gastric Cancer Patients
Acronym
EASTERN
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

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2020 (Actual)
Primary Completion Date
December 31, 2027 (Anticipated)
Study Completion Date
December 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Center, Korea
Collaborators
Incheon St.Mary's Hospital/The Catholic University, Kosin University Gospel Hospital, Pusan National University Hospital, SMG-SNU Boramae Medical Center, Chonnam National University Hospital, Chung-Ang University Hosptial, Chung-Ang University College of Medicine, Chilgok Kyungpook National University, Hallym University Medical Center, Seoul National University Hospital, Asan Medical Center

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aspirin, Gastric Cancer
Keywords
Aspirin, Gastric cancer prevention, Endoscopic submucosal dissection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aspirin
Arm Type
Active Comparator
Arm Description
Enteric coated aspirin
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Enteric coated aspirin placebo
Intervention Type
Drug
Intervention Name(s)
Aspirin 100mg
Intervention Description
Daily aspirin 100 mg for 5 years
Intervention Type
Drug
Intervention Name(s)
Placebo oral tablet
Intervention Description
Daily placebo for 5 years
Primary Outcome Measure Information:
Title
The incidence of gastric cancer between the intervention and placebo groups
Description
Histologically confirmed gastric cancer detected at follow-up endoscopy or registered at the Korean Cancer Registry
Time Frame
Until last enrolled patients take 5-year trial medication
Secondary Outcome Measure Information:
Title
All-cause mortality
Description
Mortality from any causes
Time Frame
Until last enrolled patients take 5-year trial medication
Title
The incidence of cardiovascular disease and cerebrovascular disease between the intervention and placebo groups
Description
Cardiovascular diseases (stable and unstable angina, myocardial infarction); Cerebrovascular diseases (transient ischemic attack, cerebral infarction, other small vascular infarction, etc)
Time Frame
Until last enrolled patients take 5-year trial medication
Title
The incidence of other organ cancers between the intervention and placebo groups
Description
Cancers detected at follow-up visits or registered at the Korean Cancer Registry
Time Frame
Until last enrolled patients take 5-year trial medication
Title
The incidence of gastric dysplasia (adenoma) between the intervention and placebo groups
Description
Histologically confirmed gastric dysplasia (adenoma) detected at follow-up endoscopy
Time Frame
Until last enrolled patients take 5-year trial medication
Title
Complication related to the aspirin use
Description
Gastrointestinal bleeding, intracranial hemorrhage, subarachnoid hemorrhage, and other bleeding complications
Time Frame
Until last enrolled patients take 5-year trial medication
Title
Improvement of atrophy and intestinal metaplasia
Description
Change in histologic atrophy and intestinal metaplasia grades from enrollment to subsequent endoscopic assessment
Time Frame
At the time of 5-year trial medication

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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%
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Il Ju Choi, M.D., Ph.D.
Phone
+82-31-920-2282
Email
cij1224@ncc.re.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Young-Il Kim, MD
Phone
+82-31-920-1712
Email
11996@ncc.re.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Il Ju Choi, M.D., Ph.D.
Organizational Affiliation
National Cancer Center, Korea
Official's Role
Study Director
Facility Information:
Facility Name
Pusan National University Hospital
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gwang Ha Kim, M.D., Ph.D.
Email
doc0224@pusan.ac.kr
First Name & Middle Initial & Last Name & Degree
Gwang Ha Kim, M.D., Ph.D.
Facility Name
Kosin University Gospel Hospital
City
Busan
ZIP/Postal Code
49267
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Moo In Park, M.D., Ph.D.
Email
gimipark2003@naver.com
First Name & Middle Initial & Last Name & Degree
Moo In Park, M.D., Ph.D.
Facility Name
Hallym University Chuncheon Sacred Heart Hospital
City
Chuncheon
ZIP/Postal Code
24253
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gwang Ho Baik, M.D.
Email
baikgh@hallym.or.kr
First Name & Middle Initial & Last Name & Degree
Gwang Ho Baik, M.D.
Facility Name
Kyungpook National University Chilgok Hospital
City
Daegu
ZIP/Postal Code
41404
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seong Woo Jeon, M.D., Ph.D.
Email
sw-jeon@hanmail.net
First Name & Middle Initial & Last Name & Degree
Seong Woo Jeon, M.D., Ph.D.
Facility Name
National Cancer Center
City
Goyang
ZIP/Postal Code
10408
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Il Ju Choi, M.D., Ph.D.
Email
cij1224@ncc.re.kr
First Name & Middle Initial & Last Name & Degree
Il Ju Choi, M.D., Ph.D.
Facility Name
Chonnam National University Hospital
City
Gwangju
ZIP/Postal Code
61469
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seon-Young Park, M.D., Ph.D.
Email
drpsy@naver.com
First Name & Middle Initial & Last Name & Degree
Seon-Young Park, M.D., Ph.D.
Facility Name
Incheon St.Mary's Hospital/The Catholic University
City
Incheon
ZIP/Postal Code
21431
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Byung-Wook Kim, M.D.,Ph.D.
Email
gastro@catholic.ac.kr
First Name & Middle Initial & Last Name & Degree
Byung-Wook Kim, M.D.,Ph.D.
Facility Name
Chung-Ang University Hospital
City
Seoul
ZIP/Postal Code
06973
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae Gyu Kim, M.D., Ph.D.
Email
jgkimd@cau.ac.kr
First Name & Middle Initial & Last Name & Degree
Jae Gyu Kim, M.D., Ph.D.
Facility Name
SMG-SNU Boramae Medical Center
City
Seoul
ZIP/Postal Code
07061
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ji Won Kim, M.D., Ph.D.
Email
kjwjor@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Ji Won Kim, M.D., Ph.D.
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeong Hoon Lee, M.D., Ph.D.
Email
jhlee.gi@amc.seoul.kr
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soo-Jeong Cho, M.D., Ph.D.
Email
crystal522@hanmail.net

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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