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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000002463
Receipt No. R000003015
Scientific Title A exploratory study of the efficacy and safety of oxaliplatin in combination with S-1 in the treatment of non-resectable gastric cancer
Date of disclosure of the study information 2009/09/07
Last modified on 2009/09/07

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Basic information
Public title A exploratory study of the efficacy and safety of oxaliplatin in combination with S-1 in the treatment of non-resectable gastric cancer
Acronym Oxaliplatin and S-1 therapy for gastric cancer
Scientific Title A exploratory study of the efficacy and safety of oxaliplatin in combination with S-1 in the treatment of non-resectable gastric cancer
Scientific Title:Acronym Oxaliplatin and S-1 therapy for gastric cancer
Region
Japan

Condition
Condition non-resectable gastric cancer or reccurent gastric cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and the safty of oxaliplatin and S-1 therapy for advanced gastric cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes response rate
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Chemotherapy by combination of oxaliplatin and S-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 non-resectable gastric cancer
CDDP is not effective
PS 0-2
Key exclusion criteria history of use of oxaliplatin
severe dysfuntion of major organs
Hematopoietic disorder
sensory neuropathy
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keiji Ogura
Organization Univercity of Tokyo
Division name Gasrtoenterology
Zip code
Address 7-3-1 Hongo, Bunkyo-ku Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization University of Tokyo Hospital
Division name Gastroenterology
Zip code
Address
TEL 03-3815-5411
Homepage URL
Email

Sponsor
Institute University of Tokyo Hospital
Institute
Department

Funding Source
Organization non
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
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 09 Month 07 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
2009 Year 03 Month 26 Day
Date of IRB
Anticipated trial start date
2009 Year 09 Month 01 Day
Last follow-up date
2012 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 09 Month 07 Day
Last modified on
2009 Year 09 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003015

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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