UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011900 |
|---|---|
| Receipt number | R000013887 |
| Scientific Title | Randomized control study to investigate the effect of adjuvant transcatheter arterial infusion on prevention of early recurrence in patients after radical hepatectomy of hepatocellular carcinoma |
| Date of disclosure of the study information | 2013/09/27 |
| Last modified on | 2013/09/27 01:37:23 |
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Basic information
Public title
Randomized control study to investigate the effect of adjuvant transcatheter arterial infusion on prevention of early recurrence in patients after radical hepatectomy of hepatocellular carcinoma
Acronym
Randomized control study to investigate the effect of adjuvant transcatheter arterial infusion on prevention of early recurrence in patients after radical hepatectomy of hepatocellular carcinoma
Scientific Title
Randomized control study to investigate the effect of adjuvant transcatheter arterial infusion on prevention of early recurrence in patients after radical hepatectomy of hepatocellular carcinoma
Scientific Title:Acronym
Randomized control study to investigate the effect of adjuvant transcatheter arterial infusion on prevention of early recurrence in patients after radical hepatectomy of hepatocellular carcinoma
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma (HCC)
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of adjuvant transcatheter arterial infusion on prevention of early recurrence after radical hepatectomy of HCC
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Disease-free survival
Key secondary outcomes
Within 2 years recurrence
overall recurrence
overall survival
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Transcatheter arterial infusion of CDDP(50mg/m2) in 3 and 6 month after hepatectomy.
Interventions/Control_2
Best supprtive care
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Patients aged >= 20 years to < 80 years at informed consent and notified disease
(2) Child A or B
(3) Patients with an ECOG performance status(PS) of 0 or 1
(4) Written Informed consent must be obtained
Key exclusion criteria
(1) Child C
(2) Patients under dialysis therapy
(3) Any patients judged by the investigators to be unfit to participate in the study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhisa Uchiyama |
Organization
Osaka Medical College
Division name
Department of General and Gastroenterological Surgery
Zip code
Address
2-7 Daigaku-machi, Takatsuki city Osaka 569-8686
TEL
072-683-1221
sur122@poh.osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fumitoshi Hirokawa |
Organization
Osaka Medical College
Division name
Department of General and Gastroenterological Surgery
Zip code
Address
2-7 Daigaku-machi, Takatsuki city Osaka 569-8686
TEL
072-683-1221
Homepage URL
sur122@poh.osaka-med.ac.jp
Sponsor or person
Institute
Department of General and Gastroenterological Surgery 
Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
大阪医科大学附属病院(大阪府)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 27 | 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
| 2011 | Year | 08 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2017 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2017 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 27 | Day |
Last modified on
| 2013 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013887
