UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000031675
Receipt No. R000036181
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))"
Date of disclosure of the study information 2018/03/12
Last modified on 2018/03/12

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Yu Sunakawa
Organization St. Marianna University School of Medicine
Division name Department of Clinical Oncology
Zip code
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
Middle name
Last name Masashi Fujii
Organization Japan Clinical Cancer Research Organization (JACCRO)
Division name Office
Zip code
Address 1-14-5 Ginza, Chuo-ku, Tokyo 104-0061, Japan
TEL 03-5579-9882
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 NANTOMICS, LLC
Name of secondary funder(s) NANTOMICS, LLC

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2018 Year 03 Month 12 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


Contact us.