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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000004095
Receipt No. R000004930
Scientific Title Research of pharmacokinetic and pharmacogenetic determinants of the activity and toxicity of 5-Fluorouracil in colorectal cancer patients
Date of disclosure of the study information 2010/08/24
Last modified on 2014/08/27

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Basic information
Public title Research of pharmacokinetic and pharmacogenetic determinants of the activity and toxicity of 5-Fluorouracil in colorectal cancer patients
Acronym Research of biomarkers associated with 5-FU
Scientific Title Research of pharmacokinetic and pharmacogenetic determinants of the activity and toxicity of 5-Fluorouracil in colorectal cancer patients
Scientific Title:Acronym Research of biomarkers associated with 5-FU
Region
Japan

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

Objectives
Narrative objectives1 To explore predictive biomarkers for 5-FU pharmacokinetics.
Basic objectives2 Pharmacodynamics
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes To evaluate the relationship between 5-FU pharmacokinetics and plasma biomarkers.
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)Histologically confirmed colorectal cancer
2) Patient who is intended to receive chemotherapy with continuously infused 5-fluorouracil
3)20 years of age or older
4)Performance Status (ECOG) 0-2
5)Adequate organ function obtained within 2 weeks prior to registration. Laboratory values must be as follows;
WBC count >= 3,000 /mm3
absolute neutrophil count >= 1,500 /mm3
platelet count >= 100,000 /mm3
hemoglobin >= 7.0 g/dL
AST/ALT/ALP <= 2.5 X institutional upper limit of normal
Total bilirubin less than or equal to 2.0 mg/dL
serum creatinine within 2.0 times the upper limit of normal
6) Signed informed consent
Key exclusion criteria 1) Hoped to be pregnant/nursing.
2) Allergy to fluoropyrimidine compounds
3) Simultaneous use of other fluoropyrimidine drugs
4) History of severe complicating disease
5) Active infection
6) History of bone-marrow transplantation
7) Those who received a white blood cell transfusion within 30 days before registration
8) Those judged to be not suitable by the attending physician
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ichiro Ieiri
Organization Graduate school of Pharmaceutical Science, Kyushu University
Division name Department of clinical pharmacokinetics
Zip code
Address Maidashi 3-1-1, Higashi-ku, Fukuoka city
TEL 092-642-6657
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoshimasa Shiraishi
Organization Graduate school of Pharmaceutical Science, Kyushu University
Division name Department of clinical pharmacokinetics
Zip code
Address Maidashi 3-1-1, Higashi-ku, Fukuoka city
TEL 092-642-6659
Homepage URL
Email shiraish@kokyu.med.kyushu-u.ac.jp

Sponsor
Institute Department of clinical pharmacokinetics, Graduate school of Pharmaceutical Science, Kyushu University
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Hematology and Oncology, Kyushu University Hospital
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 九州大学病院 血液腫瘍内科

Other administrative information
Date of disclosure of the study information
2010 Year 08 Month 24 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
2010 Year 06 Month 10 Day
Date of IRB
Anticipated trial start date
2010 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Blood samples are serially collected from colorectal cancer patients before and during 5-FU continuous infusion.
Relationship between 5-FU pharmacokinetics and polymorphisms are assessed.

Management information
Registered date
2010 Year 08 Month 24 Day
Last modified on
2014 Year 08 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004930

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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