UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004095 |
|---|---|
| Receipt number | 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 09:52:25 |
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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
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
shiraish@kokyu.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of clinical pharmacokinetics, Graduate school of Pharmaceutical Science, Kyushu University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004930
