AspirinPhase 3EASTERNNCT04214990
Aspirin Use for Gastric Cancer Prevention in the Early Gastric Cancer Patients
A Phase 3 study testing Aspirin 100mg in people with Aspirin and Gastric Cancer, run by National Cancer Center, Korea at 10 sites in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Aspirin, Gastric Cancer
- What is being tested?
- Aspirin 100mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,700 participants
- Where
- 10 sitesSouth Korea
- Study dates
- 15 Feb 2020to 31 Mar 2032
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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%
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
South Korea10 sites, 10 recruiting
- Recruiting
Pusan National University Hospital
Busan, 49241
Gwang Ha Kim, M.D., Ph.D., doc0224@pusan.ac.kr
Gwang Ha Kim, M.D., Ph.D.
- Recruiting
Kosin University Gospel Hospital
Busan, 49267
Moo In Park, M.D., Ph.D., gimipark2003@naver.com
Moo In Park, M.D., Ph.D.
- Recruiting
Hallym University Chuncheon Sacred Heart Hospital
Chuncheon, 24253
Gwang Ho Baik, M.D., baikgh@hallym.or.kr
Gwang Ho Baik, M.D.
- Recruiting
Kyungpook National University Chilgok Hospital
Daegu, 41404
Seong Woo Jeon, M.D., Ph.D., sw-jeon@hanmail.net
Seong Woo Jeon, M.D., Ph.D.
- Recruiting
National Cancer Center
Goyang, 10408
Il Ju Choi, M.D., Ph.D., cij1224@ncc.re.kr
Il Ju Choi, M.D., Ph.D.
- Recruiting
Chonnam National University Hospital
Gwangju, 61469
Seon-Young Park, M.D., Ph.D., drpsy@naver.com
Seon-Young Park, M.D., Ph.D.
- Recruiting
Incheon St.Mary's Hospital/The Catholic University
Incheon, 21431
Byung-Wook Kim, M.D.,Ph.D., gastro@catholic.ac.kr
Byung-Wook Kim, M.D.,Ph.D.
- Recruiting
Chung-Ang University Hospital
Seoul, 06973
Jae Gyu Kim, M.D., Ph.D., jgkimd@cau.ac.kr
Jae Gyu Kim, M.D., Ph.D.
- Recruiting
SMG-SNU Boramae Medical Center
Seoul, 07061
Ji Won Kim, M.D., Ph.D., kjwjor@snu.ac.kr
Ji Won Kim, M.D., Ph.D.
- Not yet recruiting
Asan Medical Center
Seoul
Jeong Hoon Lee, M.D., Ph.D., jhlee.gi@amc.seoul.kr
About this study
Official title: 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.
Read the 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.
- Conditions
- Aspirin, Gastric Cancer
- Being tested
- Aspirin 100mg, Placebo oral tablet
- Keywords
- Aspirin, Gastric cancer prevention, Endoscopic submucosal dissection
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin 100mgDrug
Daily aspirin 100 mg for 5 years
Placebo oral tabletDrug
Daily placebo for 5 years
| Study group | Role | What they receive |
|---|---|---|
| Aspirin | Active comparator | Enteric coated aspirin Receives: Drug: Aspirin 100mg |
| Placebo | Placebo comparator | Enteric coated aspirin placebo Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Until last enrolled patients take 5-year trial medication
Secondary outcomes (6)
All-cause mortality
Mortality from any causes
Measured: Until last enrolled patients take 5-year trial medication
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)
Measured: Until last enrolled patients take 5-year trial medication
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
Measured: Until last enrolled patients take 5-year trial medication
The incidence of gastric dysplasia (adenoma) between the intervention and placebo groups
Histologically confirmed gastric dysplasia (adenoma) detected at follow-up endoscopy
Measured: Until last enrolled patients take 5-year trial medication
Complication related to the aspirin use
Gastrointestinal bleeding, intracranial hemorrhage, subarachnoid hemorrhage, and other bleeding complications
Measured: Until last enrolled patients take 5-year trial medication
Improvement of atrophy and intestinal metaplasia
Change in histologic atrophy and intestinal metaplasia grades from enrollment to subsequent endoscopic assessment
Measured: At the time of 5-year trial medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start15 Feb 2020
- Primary completion31 Mar 2031 (estimated)
- Study completion31 Mar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AspirinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- 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 Hospital, Chilgok Kyungpook National University, Hallym University Medical Center, Asan Medical Center, Seoul National University Bundang Hospital, Severance Hospital, Samsung Medical Center
- Responsible party
- Principal investigator, Il Ju Choi, National Cancer Center, Korea
- Investigators
- Il Ju Choi, M.D., Ph.D., Study director, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04214990
- Sponsor's protocol ID
- NCC2019-0184
- Acronym
- EASTERN
- Status last verified
- Dec 2024
- First submitted
- 29 Dec 2019
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low-dose Aspirin for Stomach Cancer Prevention After Endoscopic Resection of Gastric Neoplasm (EASTERN): a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04214990
- Acronym / sponsor ID
- EASTERN / NCC2019-0184
- Conditions
- Aspirin, Gastric Cancer
- Keywords
- Aspirin, Gastric cancer prevention, Endoscopic submucosal dissection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,700 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- 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 Hospital, Chilgok Kyungpook National University, Hallym University Medical Center, Asan Medical Center, Seoul National University Bundang Hospital, Severance Hospital, Samsung Medical Center
- Study start
- 15 Feb 2020 (actual)
- Primary completion
- 31 Mar 2031 (estimated)
- Study completion
- 31 Mar 2032 (estimated)
- First posted
- 2 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspirin | Active comparator | Drug: Aspirin 100mgEnteric coated aspirin |
| Placebo | Placebo comparator | Drug: Placebo oral tabletEnteric coated aspirin placebo |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aspirin 100mgDaily aspirin 100 mg for 5 years | Drug | Aspirin |
| Placebo oral tabletDaily placebo for 5 years | Drug | Placebo |
Primary outcome
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
6 secondary outcomes
All-cause mortality
Time frame: 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
The incidence of other organ cancers between the intervention and placebo groups
Time frame: 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
Complication related to the aspirin use
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Il Ju Choi, M.D., Ph.D. study director
National Cancer Center, Korea
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aspirin 100mg in people with Aspirin and Gastric Cancer, run by National Cancer Center, Korea at 10 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Il Ju Choi, M.D., Ph.D. (+82-31-920-2282, cij1224@ncc.re.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of gastric cancer between the intervention and placebo groups (time frame: Until last enrolled patients take 5-year trial medication). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.