UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016041 |
|---|---|
| Receipt number | R000018630 |
| Scientific Title | Effect of transarterial infusion therapy using carboplatin for hepatocelluar carcinoma with macroscopic vascular invasion |
| Date of disclosure of the study information | 2014/12/24 |
| Last modified on | 2016/06/24 09:15:23 |
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Basic information
Public title
Effect of transarterial infusion therapy using carboplatin for hepatocelluar carcinoma with macroscopic vascular invasion
Acronym
Effect of transarterial infusion therapy using carboplatin for hepatocelluar carcinoma with macroscopic vascular invasion
Scientific Title
Effect of transarterial infusion therapy using carboplatin for hepatocelluar carcinoma with macroscopic vascular invasion
Scientific Title:Acronym
Effect of transarterial infusion therapy using carboplatin for hepatocelluar carcinoma with macroscopic vascular invasion
Region
| Japan |
Condition
Condition
Hepatocelluar carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We clarify the effect of transarterial infusion therapy using carboplatin for hepatocelluar carcinoma with macroscopic vascular invasion
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Desease free survival
Key secondary outcomes
respons rate of transarterial infusion therapy using CAM(carboplatin, adoriamaicin, mitomycin C), Over all survival, safty
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
transarterial infusion therapy using carboplatin
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)Resectable hepatocelluar carcinoma with macroscopic vascular invasion
2)Child-Pugh classification A
3)PS(ECOG) score:0-1
4)Documently informed consented
Key exclusion criteria
1)Case with Extrahepatic metastasis
2)Case with complication as below(excluded chronic hepatitis and chirrosis)
(1)Uncontrollable Cardiac dysfunction
(2)AMI onset within 6 months
(3)Renal failure
(4)Active infection(excluded viral hepatitis)
(5)Active GI bleeding
(6)Active double cancer
(7)Hepatic coma and mentalillness
3)Pregnantwoman,nursewoman and possible pregnantwoman
4)Case that are not suitable and not listed above
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Sugioka |
Organization
Fujita Health University School of Medicine
Division name
Depertment of hepatobiriary and transplant surgery
Zip code
Address
1-98 dengakugakubo kutukake-cho toyoake city
TEL
0562-93-9248
yoshinao@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshinao Tanahashi |
Organization
Fujita Health University School of Medicine
Division name
Depertment of hepatobiriary and transplant surgery
Zip code
Address
1-98 dengakugakubo kutukake-cho toyoake city
TEL
0562-93-9248
Homepage URL
yoshinao@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University School of Medicine
Depertment of hepatobiriary and transplant surgery
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University School of Medicine
Depertment of hepatobiriary and transplant surgery
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
| 2014 | Year | 12 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 08 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 24 | 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
| 2014 | Year | 12 | Month | 24 | Day |
Last modified on
| 2016 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018630
