UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004525 |
|---|---|
| Receipt number | R000005412 |
| Scientific Title | The effect of combination of valproic acid and anti-tumor drug on pancreatic and biliary cancer |
| Date of disclosure of the study information | 2010/11/15 |
| Last modified on | 2010/11/16 13:59:38 |
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Basic information
Public title
The effect of combination of valproic acid and anti-tumor drug on pancreatic and biliary cancer
Acronym
The effect of valproic acid on pancreatic and biliary cancer
Scientific Title
The effect of combination of valproic acid and anti-tumor drug on pancreatic and biliary cancer
Scientific Title:Acronym
The effect of valproic acid on pancreatic and biliary cancer
Region
| Japan |
Condition
Condition
unresectable or reccurrent pancreatic cancer and biliary cancer (20 patients)
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the clinical effects of valproic acid on pancreatic and biliary cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
tumor marker and tumor size
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
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
To administer valproic acid 15mg/kg twice a day.We estimate the blood concentration of valproic acid once a month. If the patients have the no side effects, we will continue to administer valproic acid. Regarding S-1, we administer this drug twice a day in alternate-day regimen.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) The patients informed of pancreatic cancer or biliary cancer
(2) Unresectable or reccurrent patients
(3) The patients taken informed consent
Key exclusion criteria
(1) The patients have severe organ disorder.
(2) The patients have more than 2.5 times of AST or ALT.
(3) The patients have more than 2mg/dl of Total-Bilirubin.
(4) The patients have more than 5mg/dl of Creatinin.
(5) The patients have less than 90% of SaO2.
(6) The patients have severe organ complication.
(7) The patiens have allergy.
(8) The patients have agressive duplication cancer.
(9) The patients is considered unaddaptive.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuji Morine |
Organization
Tokushima university hospital
Division name
Department of surgery
Zip code
Address
Kuramoto-cho 3-18-15, Tokushima, Japan
TEL
088-633-7139
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shuichi Iwahashi |
Organization
Tokushima university hospital
Division name
Department of surgery
Zip code
Address
TEL
Homepage URL
iwahashi@clin.med.tokushima-u.ac.jp
Sponsor or person
Institute
Department of surgery, Tokushima university hospital
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
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
| 2010 | Year | 11 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2010 | Year | 11 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | 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
| 2010 | Year | 11 | Month | 09 | Day |
Last modified on
| 2010 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005412
