UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A pharmacogenomics study for adverse effects and clinical outcome to S-1 in gastric cancer patients
Title of the study (Brief title)	Pharmacogenomics study for individual response to S-1
Region	Japan

Condition
Condition	gastric cancer
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To investigate the distributions of polymorphisms and their association with adverse drug reactions to S-1 in gastric cancer patients
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	To investigate the single nucleotide polymorphisms correlated with S-1 induced adverse drug reactions
Key secondary outcomes	1) To investigate the single nucleotide polymorphisms correlated with progression-free survival (advanced gastric cancer) 2) To investigate the single nucleotide polymorphisms correlated with recurrence-free survival (resectable gastric cancer)

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) Histologically or cytologically confirmed Gastric cancer 2) Life expectancy of at least 12 weeks at the pre-treatment evaluation 3) No prior chemotherapy or radiotherapy before enrollment 4) Oral intake is possible 5) 20 years of age or older 6) ECOG PS 0-2 7) Adequate organ function obtained within 2 weeks prior to registration. Laboratory values must be as follows; WBC count >= 3,000 /mm3, and <= 12,000 /mm3 absolute neutrophil count >= 1,500 /mm3, hemoglobin >= 8.0 g/dL platelet count >= 100,000 /mm3 AST <= 100 IU/L ALT <= 100 IU/L total bilirubin less than or equal to 1.5 mg/dL serum creatinine <= 1.5 mg/dL 8)Informed consent by the document
Key exclusion criteria	1) Known prior severe hypersensitivity to clinical trial medicines 2) Patients who do not have enough whole body state to the antineoplastic agents treatment 3) Pregnant, breastfeeding or expecting woman 4) Other clinical difficulties in this study
Target sample size	100

Research contact person
Name of lead principal investigator	Daiki Tsuji
Organization	Univercity of Shizuoka
Division name	School of Pharmaceutical Science
Address	52-1, Yada, Suruga-ku, Shizuoka, 422-8526, Japan
TEL	054-264-5674
Email	d-tsuji@u-shizuoka-ken.ac.jp

Public contact
Name of contact person	Daiki Tsuji
Organization	Univercity of Shizuoka
Division name	School of Pharmaceutical Science
Address	52-1, Yada, Suruga-ku, Shizuoka, 422-8526, Japan
TEL	054-264-5674
Homepage URL
Email	d-tsuji@u-shizuoka-ken.ac.jp

Sponsor
Institute	Department of Clinical Pharmacology and Genitics, School of Pharmaceutical Science, Univercity of Shizuoka
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)

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	2011 Year 02 Month 10 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2010 Year 12 Month 17 Day
Anticipated trial start date	2011 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Blood samples are collected from gastric cancer patients before S-1 oral administration. Relationship between adverse drug reactions of S-1 and genitic polymorphisms are assessed.

Management information
Registered date	2011 Year 01 Month 27 Day
Last modified on	2018 Year 08 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000005834