UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035580 |
|---|---|
| Receipt number | R000040542 |
| Scientific Title | Prospective pharmacokinetic study of continuous-infusional 5-FU |
| Date of disclosure of the study information | 2019/01/18 |
| Last modified on | 2021/07/14 12:54:35 |
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Basic information
Public title
Prospective pharmacokinetic study of continuous-infusional 5-FU
Acronym
Pharmacokinetic study of 5-FU
Scientific Title
Prospective pharmacokinetic study of continuous-infusional 5-FU
Scientific Title:Acronym
Pharmacokinetic study of 5-FU
Region
| Japan |
Condition
Condition
Gastrointestinal Cancers
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine inter-individual variability in pharmacokinetics of BSA based 5-FU continuous intravenous infusion.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Distribution of area under the time-concentration couve (AUC) of 5-FU
Key secondary outcomes
Correlation of AUC and 5-FU related adverse events.
Impact of patient characteristics on AUC.
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)Patients who are planned for treatment with modified de Gramont regimen (5-FU 400mg/m2 bolus + 2400mg/m2 div + leucovorin) including mFOLFOX6, FOLFIRI, FOLFIRINOX, 5-FU/LV
Key exclusion criteria
1)Uncontrolled diarrhea (Grade =>2)
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Tanigawara |
Organization
Keio University, School of Medicine
Division name
Department of clinical pharmacokinetics and pharmacodynamics
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3847
tanigawara@a7.keio.jp
Public contact
Name of contact person
| 1st name | Chiyo |
| Middle name | K. |
| Last name | Imamura |
Organization
Keio University, School of Medicine
Division name
Department of clinical pharmacokinetics and pharmacodynamics
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3706
Homepage URL
imamurack@z3.keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Keio University
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
Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel
03-5363-3503
med-rinri-jimu@adst.keio.ac.jp
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
国立がん研究センター中央病院（東京都）
慶應義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | Month | 18 | 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
| 2018 | Year | 10 | Month | 16 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 11 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2019 | Year | 01 | Month | 18 | Day |
Last modified on
| 2021 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040542
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
