UMIN-CTR Clinical Trial

Basic information
Public title	Multicenter prospective observational study for the usefulness of geriatric assessment before chemotherapy in elderly patients with gastric cancer
Acronym	GA study
Scientific Title	Multicenter prospective observational study for the usefulness of geriatric assessment before chemotherapy in elderly patients with gastric cancer
Scientific Title:Acronym	GA study
Region	Japan

Condition
Condition	Gastric cancer
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To elucidate the relationship between geriatric assessment before chemotherapy and adverse event rates or treatment results in elderly patients with gastric cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Adverse event rates of grade 3-4 during first-line chemotherapy
Key secondary outcomes	RDI(Relative dose intensity) during first-line chemotherapy, overall survival (OS), progression free survival (PFS), overall response rate (ORR), time to treatment failure (TTF), and the relationship between GA scores and adverse events or treatment results

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	70 years-old <
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	ECOG PS 0-2 Patients who are going to receive platinum combination chemotherapy Patients who have written informed consent Patients over 70 years old
Key exclusion criteria	Recurrent cases during preoperative or postoperative chemotherapy Cases of clinical trial Patients who can not understand disease condition due to severe cognitive impairment
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Yoshiyasu Middle name Last name Kono
Organization	Okayama University Hospital
Division name	Gastroenterology
Zip code	700-8558
Address	2-5-1, Shikata-cho, Kita-ku, Okayama City
TEL	086-235-7219
Email	hxnwq178@yahoo.co.jp

Public contact
Name of contact person	1st name Yoshiyasu Middle name Last name Kono
Organization	Okayama University Hospital
Division name	Gastroenterology
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 Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Okayama University Hospital, Ethics Comittee
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	2022 Year 08 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	2022 Year 07 Month 22 Day
Date of IRB	2022 Year 07 Month 22 Day
Anticipated trial start date	2022 Year 08 Month 01 Day
Last follow-up date	2025 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2026 Year 06 Month 30 Day

Other
Other related information	None

Management information
Registered date	2022 Year 08 Month 09 Day
Last modified on	2022 Year 08 Month 09 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055410