UMIN-CTR Clinical Trial

Basic information
Public title	Biomarker study of "A Phase III Trial of Docetaxel plus S-1 versus S-1 Alone in the Treatment of Curatively Resected Stage III Gastric Cancer (JACCRO GC-07(START-2))"
Acronym	Biomarker study of "A Phase III Trial of Docetaxel plus S-1 versus S-1 Alone in the Treatment of Curatively Resected Stage III Gastric Cancer (JACCRO GC-07(START-2))"
Scientific Title	Biomarker study of "A Phase III Trial of Docetaxel plus S-1 versus S-1 Alone in the Treatment of Curatively Resected Stage III Gastric Cancer (JACCRO GC-07(START-2))"
Scientific Title:Acronym	Biomarker study of "A Phase III Trial of Docetaxel plus S-1 versus S-1 Alone in the Treatment of Curatively Resected Stage III Gastric Cancer (JACCRO GC-07(START-2))"
Region	Japan

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

Objectives
Narrative objectives1	The purpose of this study is to identify predictive markers for docetaxel or S-1 in resectable gastric cancer.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	To evaluate if TUBB3 expression serves as a predictor for docetaxel by analyzing PFS and OS in docetaxel plus S-1 arm and S-1 alone arm according to TUBB3 status.
Key secondary outcomes	To evaluate associations of PFS and OS with TS, DPYD, OPRT, and TYMP expression in S-1 alone arm. To investigate correlation of PFS and OS with gene expression or mutations in each arm.

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who are registered in JACCRO GC-07 trial (UMIN 000010337), include the following: (1) Resected tumor tissue samples available (2) Approved to supply the tissue sample for this study by IRB.
Key exclusion criteria	(1) Patients who are considered as inadequate for study enrollment by investigators. (2) Patients who refuse the use of samples for study.
Target sample size	800

Research contact person
Name of lead principal investigator	1st name Yu Middle name Last name Sunakawa
Organization	St. Marianna University School of Medicine
Division name	Department of Clinical Oncology
Zip code	216-8511
Address	2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511, Japan
TEL	044-977-8111
Email	y.sunakawa@marianna-u.ac.jp

Public contact
Name of contact person	1st name Masashi Middle name Last name Fujii
Organization	Japan Clinical Cancer Research Organization (JACCRO)
Division name	Office
Zip code	101-0051
Address	6F Jimbocho Kyowa Bldg. 1-64 Kanda-Jimbocho, Chiyoda-ku, Tokyo 101-0051
TEL	03-6811-0433
Homepage URL
Email	gc07.dc@jaccro.or.jp

Sponsor
Institute	Japan Clinical Cancer Research Organization (JACCRO)
Institute
Department

Funding Source
Organization	Japan Clinical Cancer Research Organization (JACCRO
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	Japan Clinical Cancer Research Organization Institutional Review Board
Address	6F Jimbocho Kyowa Bldg. 1-64 Kanda-Jimbocho, Chiyoda-ku, Tokyo 101-0051
Tel	03-6811-0433
Email	irb-jaccro@jaccro.or.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	聖マリアンナ医科大学（神奈川県）他

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 12 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	Enrolling by invitation
Date of protocol fixation	2018 Year 02 Month 07 Day
Date of IRB
Anticipated trial start date	2018 Year 03 Month 01 Day
Last follow-up date	2022 Year 09 Month 30 Day
Date of closure to data entry	2022 Year 09 Month 30 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information	This is a translational study to identify novel biomarkers for adjuvant chemotherapy in resectable gastric cancer using tissue samples of the JACCRO GC-07 trial (START-2).

Management information
Registered date	2018 Year 03 Month 12 Day
Last modified on	2021 Year 01 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036181

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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