UMIN-CTR Clinical Trial

Basic information
Public title	Prospective observational study for the safety and efficacy of chemotherapy in gastric cancer
Acronym	Prospective study for the chemotherapy in gastric cancer
Scientific Title	Prospective observational study for the safety and efficacy of chemotherapy in gastric cancer
Scientific Title:Acronym	Prospective study for the chemotherapy in gastric cancer
Region	Japan

Condition
Condition	gastric cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To clarify the reality of chemotherapy in gastric cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Overall survival (OS) and the contributing factors associated with OS
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Inpatients and outpatients who were diagnosed gastric cancer and receive chemotherapy from the permission of ethics committee to March 31,2026. 2. Patients who can offer written informed consent 3. Patients with 20 years and over
Key exclusion criteria	1. Patients who are not suitable for chemotherapy 2. Patients who reject chemotherapy
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Toshiyoshi Middle name Last name Fujiwara
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Department of Gastroenterological Surgery
Zip code	700-8558
Address	2-5-1, Shikata-cho, Kita-ku, Okayama City
TEL	086-235-7257
Email	toshi_f@md.okayama-u.ac.jp

Public contact
Name of contact person	1st name Yoshiyasu Middle name Last name Kono
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Department of Gastroenterology and Hepatology
Zip code	700-8558
Address	2-5-1, Shikata-cho, Kita-ku, Okayama City
TEL	086-235-7219
Homepage URL
Email	hxnwq178@yahoo.co.jp

Sponsor
Institute	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address	2-5-1, Shikata-cho, Kita-ku, Okayama City
Tel	086-235-6938
Email	mae6605@adm.okayama-u.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	2021 Year 07 Month 09 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
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	Open public recruiting
Date of protocol fixation	2021 Year 07 Month 07 Day
Date of IRB	2021 Year 06 Month 04 Day
Anticipated trial start date	2021 Year 07 Month 08 Day
Last follow-up date	2029 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2030 Year 03 Month 31 Day

Other

Other related information

Advanced and unresectable gastric cancer or resectable gastric cancer patients who receive chemotherapy or adjuvant chemotherapy are included. Clinical data about patient background and treatment(age, sex, types of regimen, treatment start date, stage, performance status, HER2 status, metastasis cite,and laboratory data, treatment end date, adverse effect, best response, and resection of primary lesion) are collected.

Management information
Registered date	2021 Year 07 Month 09 Day
Last modified on	2021 Year 07 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051179