UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000690 |
|---|---|
| Receipt number | R000000827 |
| Scientific Title | A randomized controlled trial of transcatheter arterial chemoembolization(TACE) in patients with advanced hepatocellular:Comparison of periodical TACE versus recurrence time TACE |
| Date of disclosure of the study information | 2007/11/01 |
| Last modified on | 2012/04/25 19:41:58 |
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Basic information
Public title
A randomized controlled trial of transcatheter arterial chemoembolization(TACE) in patients with advanced hepatocellular:Comparison of periodical TACE versus recurrence time TACE
Acronym
Comparison of periodical TACE vs recurrence time TACE
Scientific Title
A randomized controlled trial of transcatheter arterial chemoembolization(TACE) in patients with advanced hepatocellular:Comparison of periodical TACE versus recurrence time TACE
Scientific Title:Acronym
Comparison of periodical TACE vs recurrence time TACE
Region
| Japan |
Condition
Condition
advanced hepatocellular carcinoma(HCC)
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
TACE is recommended for the treatment of advanced HCC.
The purpose of this study is to evaluate the therapeutic efficacy of TACE in two different schedules.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
cumulative survival rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is 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 was underwent when the recurrence of HCC was observed via follow-up dynamic CT or MRI.
However, when no recurrence of HCC was observed, planned periodic TACE was repeated at 6 month intervals.
Interventions/Control_2
TACE was repeated only when the recurrence of HCC was observed via follow-up dynamic CT or MRI.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
a)patients with untreated HCC not suitable for curative treatment
b)Child A or B
c)hypervascular tumor diagnosed via dynamic CT or MRI
d)TNMStage 2-3
e) PS 0-2
f)serum creatinine level below 2mg/dl
g)Age is within 20-79 years old
Key exclusion criteria
a)patients with HCC suitable for curative treatment
b)Child C
c)allergy of contrast medium
d)list of living donor liver transplantation
e)portal vein tumor thrombus
f)extrahepatic metastasis
g)sponteneous tumor rupture
h)The patients whom judged to be inadequate by clinical trial liability or clinical trial allotment doctor.
Target sample size
78
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Takuma |
Organization
National Hospital Organization Iwakuni Clinical Center
Division name
Internal Medicine
Zip code
Address
2-5-1 Kuroiso-cho, Iwakuni, Yamaguchi , Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
National Hospital Organization Iwakuni Clinical Center
Division name
Department of Clinical Research
Zip code
Address
TEL
Homepage URL
takuma@iwakuni-nh.go.jp
Sponsor or person
Institute
Department of Clinical Research, National Hospital Organization Iwakuni Clinical Center
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Cancer Research(19-23)from the Ministry of Health, Labour and Welfare
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
| 2007 | Year | 11 | 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
Terminated
Date of protocol fixation
| 2007 | Year | 04 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2007 | Year | 04 | Month | 25 | Day |
Last modified on
| 2012 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000827
