UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014252 |
|---|---|
| Receipt number | R000016601 |
| Scientific Title | Evaluation of conversion rate after transarterial chemoemobolization using for unresectable hepatocellular carcinoma |
| Date of disclosure of the study information | 2014/06/13 |
| Last modified on | 2015/07/19 10:04:38 |
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Basic information
Public title
Evaluation of conversion rate after transarterial chemoemobolization using for unresectable hepatocellular carcinoma
Acronym
Conversion rate after CDDP-TACE for unresectable HCC
Scientific Title
Evaluation of conversion rate after transarterial chemoemobolization using for unresectable hepatocellular carcinoma
Scientific Title:Acronym
Conversion rate after CDDP-TACE for unresectable HCC
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the conversion rate for salvage surgery after transarterial chemoemobolization (TACE) using cisplatin (CDDP) for advanced unresectable hepatocellular carcinoma
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Conversion rate for salvage surgery
Key secondary outcomes
Response rate for TACE, Time to progression (TTP), Overall survival (OS), disease-free survival time after salvage hepatectomy, completion rate, safty & adverse event
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 | Maneuver |
Interventions/Control_1
Transarterial chemoembolization using cisplatin (CDDP-TACE),
Liver resection
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Histologically or clinical diagnosed hepatocellular carcinoma
2) A proper indication for TACE without indication of surgery or ablation therapy
3) 20 years old and more
4) Performance status (ECOG) 0 or 1
5) life expectantcy of at least 6 months
6) Child-pugh A or B
7) Satisfying following blood test before registration
WBC >=2,000/micro litter
Neu >=1,000/micro litter
Hb >= 8.5g/dL
Platelet >=70,000 /micro litter
Total bilirubin <=1.5 mg/dl
AST [GOT] <= 150 IU/L
ALT [GPT] <= 150 IU/L
Creatinine <= 1.2 mg/dL
8) Primary cases or recurrence cases after hepatectomy or RFA
9) Agreement to be enrolled in a form of informed consent
Key exclusion criteria
1) Patologically diagnosed as combined hepatocellular and cholangiocellular carcinoma
2) Extrahepatic metastasis
3) Vascular involvement Vp3 or more
4) Hepatic encephalopathy
5) Active infection except for HBV and HCV
6) Severee complications
7) acitve double cancer
8) Pregnant, possibility of pregnancy, or feeding a baby Pregnancy
9) Medication that may affect to the absorption of drug or pharmacokinetics
10) Other factors that a responsible doctor judged to be unsuitable
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroaki Nagano |
Organization
Graduate School of Medicine, Osaka University
Division name
Department of Surgery
Zip code
Address
2-2, Yamadaoka, Suita, Osaka, 565-0871, Japan
TEL
06-6879-3251
hnagano@gesurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Wada |
Organization
Graduate School of Medicine, Osaka University
Division name
Department of Surgery
Zip code
Address
2-2, Yamadaoka, Suita, Osaka, 565-0871, Japan
TEL
06-6879-3251
Homepage URL
hwada98@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Multicenter Clinical Study Group of Osaka
Institute
Department
Personal name
Funding Source
Organization
Non
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 | 06 | Month | 13 | 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
| 2013 | Year | 06 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 13 | 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 | 06 | Month | 12 | Day |
Last modified on
| 2015 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016601
