UMIN-CTR Clinical Trial

Basic information
Public title	Metachronous gastric cancer prevention with aspirin:A multi-center randomized trial
Acronym	MEGA trial
Scientific Title	Metachronous gastric cancer prevention with aspirin:A multi-center randomized trial
Scientific Title:Acronym	MEGA trial
Region	Japan Asia(except Japan)

Condition
Condition	Patients who underwent endoscopic submucosal dissection (ESD) for early gastric cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We aim to test the hypothesis that aspirin can reduce the occurrence of metachronous gastric cancer after ESD.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Cumulative incidence rate of metachronous gastric carcinoma at 5 years after ESD.
Key secondary outcomes	Adverse events rate Histological evaluation of gastric mucosal atrophy and intestinal metaplasia Microbiota changes in stool and oral swab

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	Aspirin 81 mg once daily for up to 5 years
Interventions/Control_2	Nothing
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Achieved absolute or expanded curative resection with ESD defined as per JGCA guidelines 2) Aged 20-80 years 3) Performance Status (ECOG) 0, 1, or 2 4) H. pylori infection was eradicated within 5 years or negative before enrollment 5) Will be followed over 5 years 6) Written informed consent
Key exclusion criteria	1) Allergy to aspirin treatment 2) Other gastric neoplasm including low grade adenoma remain 3) A history of H. pylori eradication therapy received more than 5 years ago 4) Lesions of Siewert Type II (<2 cm from the OGJ at the epicenter) 5) A history of gastric surgery 6) Severe co-morbidities and estimated life expectancy less than 3 years 7) Already on aspirin or other antithrombotic drugs prior to randomization 8) Using NSAIDs 9) Using Metformin 10) A history of peptic ulcers 11) A history of stroke 12) Receiving chemotherapy 13) Disorder of blood coagulation or platelet < 100,000/microliter 14) Pregnancy 15) Breast-feeding 16) Lack of informed consent
Target sample size	1120

Research contact person
Name of lead principal investigator	1st name Takuji Middle name Last name Gotoda
Organization	Nihon University School of Medicine
Division name	Division of Gastroenterology and Hepatology, Department of Medicine,
Zip code	101-8309
Address	1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo, Japan
TEL	03-3293-1711
Email	takujigotoda@yahoo.co.jp

Public contact
Name of contact person	1st name Sho Middle name Last name Suzuki
Organization	Nihon University School of Medicine
Division name	Division of Gastroenterology and Hepatology, Department of Medicine,
Zip code	101-8309
Address	1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo, Japan
TEL	03-3293-1711
Homepage URL
Email	s.sho.salubriter.mail@gmail.com

Sponsor
Institute	MEGA trial Group
Institute
Department

Funding Source
Organization	Japan Strategic Medical Administration Research Center: J-SMARC
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional Review Board of Nippon Medical School Foundation
Address	1-1-5, Sendagi, Bunkyoku, Tokyo, Japan
Tel	03-5802-8202
Email	officetokutei@nms.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2018 Year 02 Month 14 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	50
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2019 Year 02 Month 04 Day
Date of IRB	2019 Year 02 Month 25 Day
Anticipated trial start date	2019 Year 06 Month 01 Day
Last follow-up date	2027 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 02 Month 14 Day
Last modified on	2020 Year 04 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035504