UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007460 |
|---|---|
| Receipt number | R000008797 |
| Scientific Title | Effect of genetic polymorphism of glutahione S-transferases for the pharmacokinetics and adverse effects of oxaliplatin in patients with colorectal cancer |
| Date of disclosure of the study information | 2012/03/06 |
| Last modified on | 2015/09/29 19:50:12 |
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Basic information
Public title
Effect of genetic polymorphism of glutahione S-transferases for the pharmacokinetics and adverse effects of oxaliplatin in patients with colorectal cancer
Acronym
Effect of genetic polymorphism of glutahione S-transferases for the pharmacokinetics and adverse effects of oxaliplatin in patients with colorectal cancer
Scientific Title
Effect of genetic polymorphism of glutahione S-transferases for the pharmacokinetics and adverse effects of oxaliplatin in patients with colorectal cancer
Scientific Title:Acronym
Effect of genetic polymorphism of glutahione S-transferases for the pharmacokinetics and adverse effects of oxaliplatin in patients with colorectal cancer
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
We investigate influence of genetic polymorphism of glutathione S-transferase (GST) on the pharmacokinetics(PK) parameter and adverse effects of oxaliplatin (L-OHP) in patients with colorectal cancer.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
genetic polymorphism of GST and PK parameter of L-OHP
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
Duration of study:2 years
Dose of oxalipatin
Times of blood sampling:11 times
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.patients with colorectal cancer who recieve mFOLFOX6+bevacizumab or mFOLFOX6
2.Performance Status:0~1
Key exclusion criteria
1.patients with severe hepatotoxicity or nephrotoxicity
2.patients with neuropathy
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuhki Sato |
Organization
Oita University Hospital
Division name
Pharmacy
Zip code
Address
1-1, Idaigaoka, Hasama-machi, Yuhu-shi, Oita
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Oita University Hospital
Division name
Oita University Hospital
Zip code
Address
TEL
Homepage URL
syuhki@oita-u.ac.jp
Sponsor or person
Institute
Oita University Hospita
Institute
Department
Personal name
Funding Source
Organization
Oita University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 03 | Month | 06 | 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
| 2010 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | 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
Management information
Registered date
| 2012 | Year | 03 | Month | 06 | Day |
Last modified on
| 2015 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008797
