UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000975 |
|---|---|
| Receipt number | R000001170 |
| Scientific Title | Expanded Treatment Efficacy and Safety Study of Transcatheter Arterial Chemoembolization for Unresectable Hepatocellular Carcinoma with Epirubicin/ Doxorubicin-Lipiodol Emulsion and Gelatin Particles: Korea-Japan Cooperative Study (JIVROSG-0604) |
| Date of disclosure of the study information | 2008/01/08 |
| Last modified on | 2012/03/10 18:55:32 |
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Basic information
Public title
Expanded Treatment Efficacy and Safety Study of Transcatheter Arterial Chemoembolization for Unresectable Hepatocellular Carcinoma with Epirubicin/ Doxorubicin-Lipiodol Emulsion and Gelatin Particles: Korea-Japan Cooperative Study (JIVROSG-0604)
Acronym
Expanded Treatment Efficacy and Safety Study of TACE for Unresectable HCC: Korea-Japan Cooperative Study (JIVROSG-0604)
Scientific Title
Expanded Treatment Efficacy and Safety Study of Transcatheter Arterial Chemoembolization for Unresectable Hepatocellular Carcinoma with Epirubicin/ Doxorubicin-Lipiodol Emulsion and Gelatin Particles: Korea-Japan Cooperative Study (JIVROSG-0604)
Scientific Title:Acronym
Expanded Treatment Efficacy and Safety Study of TACE for Unresectable HCC: Korea-Japan Cooperative Study (JIVROSG-0604)
Region
| Japan | Asia(except Japan) |
Condition
Condition
hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate survival, safety, and response rate obtained with TACE for unresectable HCC with epirubicin/ doxorubicin-Lipiodol emulsion and gelatin particles.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
2-year survival rate
Key secondary outcomes
incidence and grade of adverse events, response rate
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
Patients with unresectable HCC undergo TACE using an emulsion of epirubicin HCl or doxorubicin HCl and Lipiodol, followed by injection of gelatin sponge particles. The same treatment is repeated if the tumor demonstrates progression.
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 clinically diagnosed HCC (excluding the mixed type)
2) No previous treatment for HCC
3) No indication for hepatic resection, liver transplantation or local ablative therapy (radiofrequency ablation, etc.)
4) Hypervascular lesion showing enhancement in the early phase on CT or MRI with bolus contrast injection
5) No tumor thrombus in the first branch or main portal vein
6) Eastern Cooperative Oncology Group performance status of 0 to 2
7) Child-Pugh classification of A or B
8) Adequate hematologic, hepatic, renal, and cardiac function; laboratory tests within two weeks before registration in the study are defined as:
(1) WBC : >= 3,000/mm2
(2) Platelet count : >=50,000/mm3
(3) Serum bilirubin : <=3.0 mg/dL
9) Patient age 20 years and above
10) Written informed consent
Key exclusion criteria
1) Extrahepatic metastasis
2) Hepatic vein invasion or biliary invasion
3) Ruptured tumor
4) Prior surgical reconstruction or endoscopic treatment of the biliary tract
5) Clinically significant refractory ascites or pleural effusion
6) Severe arterio-portal or arterio-venous shunts in the liver
7) Allergy to contrast medium that precludes angiography
8) Severe, active co-morbidity, defined as follows:
- Uncontrolled cardiac failure, angina and/or rhythm disorders
- Myocardial infarction within the last 6 months
- Renal failure
- Active infection (viral hepatitis is allowed)
- Active gastrointestinal bleeding
- Other active malignant tumor
- Hepatic encephalopathy or severe mental disorder
9) Pregnancy, nursing women, or women of childbearing potential, and men who are sexually active and not willing or able to use medically acceptable forms of contraception
10) Not eligible because of safety issues judged by investigators
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takuji Okusaka |
Organization
National Cancer Center Hospital
Division name
Hepatobiliary and Pancreatic Oncology Division
Zip code
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL
03-3542-2511
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masafumi Ikeda |
Organization
National Cancer Center Hospital
Division name
Hepatobiliary and Pancreatic Oncology Division
Zip code
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL
03-3542-2511
Homepage URL
http://jivrosg.umin.jp/koreajapan_top.html
masikeda@ncc.go.jp
Sponsor or person
Institute
Japan Interventional Radiology in Oncology Study Group (JIVROSG)
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Korea Interventional Radiology in Oncology Study Group (KIVROSG)
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
| 2008 | Year | 01 | Month | 08 | Day |
Related information
URL releasing protocol
http://jivrosg.umin.jp/koreajapan_top.html
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
Completed
Date of protocol fixation
| 2007 | Year | 10 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 01 | Month | 08 | Day |
Last modified on
| 2012 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001170
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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