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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001892
Receipt No. R000002174
Scientific Title Association between genetic polymorphism and adverse events or effectiveness of S-1-based chemotherapy in patients with gastrointestinal cancer
Date of disclosure of the study information 2009/04/16
Last modified on 2012/10/16

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Basic information
Public title Association between genetic polymorphism and adverse events or effectiveness of S-1-based chemotherapy in patients with gastrointestinal cancer
Acronym TCO-TYMS2009
Scientific Title Association between genetic polymorphism and adverse events or effectiveness of S-1-based chemotherapy in patients with gastrointestinal cancer
Scientific Title:Acronym TCO-TYMS2009
Region
Japan

Condition
Condition gastrointestinal cancer
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Hematology and clinical oncology
Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To investigate the association between genetic polymorphisms and adverse events or effectiveness of S-1-based chemotherapy in patients with gastrointestinal cancer
Basic objectives2 Others
Basic objectives -Others Phagmacogenetics
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incidence of adverse events
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. Patients who either completed, currently recieving, or are going to receive S-1-based chemotherapy at Outpatient Oncology Unit, Kyoto University Hospital
2. Patients who have histologically confirmed, unresectable advanced or recurrent gastric, pancreatic, biliary tract or colorectal cancer
3. Patients who provided written informed consent
Key exclusion criteria 1. Patients with at least 6 months S-1 free interval if they were re-treated by S-1-based chemotherapy (e.g. recurrence after adjuvant chemotherapy)
2. Patients who were judged ineligible by investigator
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takafumi Nishimura
Organization Kyoto University Hospital
Division name Outpatient Oncology Unit
Zip code
Address 54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takafumi Nishimura
Organization Kyoto University Hospital
Division name Outpatient Oncology Unit
Zip code
Address
TEL
Homepage URL
Email nisimura@kuhp.kyoto-u.ac.jp

Sponsor
Institute Graduate School of Medicine, Kyoto University
Institute
Department

Funding Source
Organization Taiho Pharmaceutical
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

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

Other administrative information
Date of disclosure of the study information
2009 Year 04 Month 16 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 Completed
Date of protocol fixation
2009 Year 03 Month 13 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information TYMS, UMPS, DPYD, MTHR

Management information
Registered date
2009 Year 04 Month 16 Day
Last modified on
2012 Year 10 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002174

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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