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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000002166
Receipt No. R000002612
Scientific Title A genotype-directed dose finding study of irinotecan based on UGT1A1 polymorphisms in metastatic colorectal cancer
Date of disclosure of the study information 2009/08/01
Last modified on 2013/03/26

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Basic information
Public title A genotype-directed dose finding study of irinotecan based on UGT1A1 polymorphisms in metastatic colorectal cancer
Acronym A genotype-directed dose finding study of irinotecan based on UGT1A1 polymorphisms in metastatic colorectal cancer
Scientific Title A genotype-directed dose finding study of irinotecan based on UGT1A1 polymorphisms in metastatic colorectal cancer
Scientific Title:Acronym A genotype-directed dose finding study of irinotecan based on UGT1A1 polymorphisms in metastatic colorectal cancer
Region
Japan

Condition
Condition metastatic colorectal cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 A genotype-directed dose finding study of irinotecan based on UGT1A1 polymorphisms in metastatic colorectal cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes adverse events
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 genotype directed dose finding study of irinotecan
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
18 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria metastatic colorectal cancer
PS0,1
no prior chemotherapy of irinotecan
Key exclusion criteria PS2,3
prior chemotherapy of irinotecan
Target sample size 18

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hironobu Minami
Organization kobe University Hospital and Graduate School of Medicine
Division name Medical Oncology,Department of Medicine
Zip code
Address 7-5-2kusunoki-cho,chuo-ku,kobe,Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization kobe University Hospital and Graduate School of Medicine
Division name Medical Oncology,Department of Medicine
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute kobe University Hospital and Graduate School of Medicine
Institute
Department

Funding Source
Organization kobe University Hospital and Graduate School of Medicine
Organization
Division
Category of Funding 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 08 Month 01 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 Terminated
Date of protocol fixation
2009 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 08 Month 01 Day
Last follow-up date
2011 Year 07 Month 01 Day
Date of closure to data entry
2013 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 07 Month 05 Day
Last modified on
2013 Year 03 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002612

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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