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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000975
Receipt No. 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

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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
Email

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
Email masikeda@ncc.go.jp

Sponsor
Institute Japan Interventional Radiology in Oncology Study Group (JIVROSG)
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001170

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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