UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003167 |
|---|---|
| Receipt number | R000003839 |
| Scientific Title | Evaluation of effectiveness of combined TACE and RFA for medium-sized HCC |
| Date of disclosure of the study information | 2010/03/01 |
| Last modified on | 2010/02/10 19:16:00 |
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Basic information
Public title
Evaluation of effectiveness of combined TACE and RFA for medium-sized HCC
Acronym
Evaluation of effectiveness of combined TACE and RFA
Scientific Title
Evaluation of effectiveness of combined TACE and RFA for medium-sized HCC
Scientific Title:Acronym
Evaluation of effectiveness of combined TACE and RFA
Region
| Japan |
Condition
Condition
HCC
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to evaluate effectiveness of combined TACE and RFA for medium-sized HCC
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
overall survival rates
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
TACE+RFA
Interventions/Control_2
TACE
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Stage 2-3
Child Pugh A, B
PT>80%
Key exclusion criteria
Child C
Extrahepatic metastasis
PT<80%
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiya Shibata |
Organization
Kyoto University Hospital
Division name
Devision of Radiology
Zip code
Address
54-Kawaharacho, Shogoin, Sakyoku, Kyoto-shi
TEL
075-751-4391
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiya Shibata |
Organization
Kyoto University Hospital
Division name
Devision of Radiology
Zip code
Address
TEL
Homepage URL
ksj@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto University Graduate School of Medicine
Organization
Division
Category of Funding Organization
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 | 03 | Month | 01 | 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 | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 02 | Month | 10 | Day |
Last modified on
| 2010 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003839
