UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017508 |
|---|---|
| Receipt number | R000020297 |
| Scientific Title | Study of blood platinum concentration transition in TACE using the cisplatin containing Hepasufhia |
| Date of disclosure of the study information | 2015/05/12 |
| Last modified on | 2016/05/16 11:56:21 |
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Basic information
Public title
Study of blood platinum concentration transition in TACE using the cisplatin containing Hepasufhia
Acronym
CDDP-Hepasphia pharmacokinetics study
Scientific Title
Study of blood platinum concentration transition in TACE using the cisplatin containing Hepasufhia
Scientific Title:Acronym
CDDP-Hepasphia pharmacokinetics study
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Objective is measured cisplatin elution amount from Hepasufhia using the blood platinum concentration transition.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
complication
Key secondary outcomes
response evaluation
overall survival
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 | Device,equipment | Maneuver |
Interventions/Control_1
DEB-TACE using the cisplatin (50mg)containing Hepasufhia (50-100 micro m).
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
| 30 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1 No indication for surgical resection.
2 Histologically or clinically cobfirmed hepatocellular carcinoma.
3 Ages 30 to 80 years old.
4 Life expectancy is more than 3months
5 Written informed consent was obtained.
6 ECOG performance status is 0 or 1.
7 Sufficient function of main organ (born marrow, kidney, heart ) and conditions filled the following criteria.
Key exclusion criteria
1 Previous operation or RFA or PEIT within 1 year.
2 Extrahepatic metastasis or lymph nodes metastasis.
3 Active cancer of the other organs.
4 Active double cancers.
5 Concurrent infections(without hepatitis virus).
6 Medical history of severe hypersensitivity.
7 Pregnant, lacting women or women with suspected pregnancy.
8 Inappropriate patients for this study judged by physicians.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroaki Nagamatsu |
Organization
Yame General Hospital
Division name
Department of Hepatology
Zip code
Address
540-2,Takatsuka,Yame,Fukuoka,834-0034
TEL
0943-23-4131
ymhp0389@yamehp.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yohei Kooka |
Organization
Yame General Hospital
Division name
Department of Hepatology
Zip code
Address
540-2,Takatsuka,Yame,Fukuoka,834-0034
TEL
0943-23-4131
Homepage URL
ymhp0389@yamehp.jp
Sponsor or person
Institute
Yame General Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2015 | Year | 05 | Month | 12 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 05 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 12 | 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
| 2015 | Year | 05 | Month | 11 | Day |
Last modified on
| 2016 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020297
| 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 |
