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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000049
Receipt No. R000000090
Scientific Title A phase I/II study of transarterial chemoembolization with cisplatin for hepatocellular carcinoma (JIVROSG-0401)
Date of disclosure of the study information 2005/08/07
Last modified on 2012/09/21

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Basic information
Public title A phase I/II study of transarterial chemoembolization with cisplatin for hepatocellular carcinoma (JIVROSG-0401)
Acronym Transarterial chemoembolization with cisplatin for hepatocellular carcinoma(JIVROSG-0401)
Scientific Title A phase I/II study of transarterial chemoembolization with cisplatin for hepatocellular carcinoma (JIVROSG-0401)
Scientific Title:Acronym Transarterial chemoembolization with cisplatin for hepatocellular carcinoma(JIVROSG-0401)
Region
Japan

Condition
Condition Unresectable hypervascular hepatocellular carcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine Hematology and clinical oncology Hepato-biliary-pancreatic surgery
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determine the dose limiting toxicity (DLT) and the recommended dose (RD) of cisplatin on hepatic arterial chemoembolization for unresectable hypervascular hepatocellular carcinoma, and to evaluate safety and tumor response with this therapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Adverse events
Key secondary outcomes Response rate of liver tumor and overall 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
Maneuver
Interventions/Control_1 Patients undergo transarterial chemoembolization comprising intra-arterial infusion of cisplatin over 20-40 minutes followed by embolization with gelatin sponge particle until elimination of tumor stain is observed on proper hepatic arteriogram.
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
75 years-old >
Gender Male and Female
Key inclusion criteria 1) Histologically or clinically confirmed hepatocellular carcinoma.
2) No definitive extra-hepatic lesions and no indication for hepatic resection.
3) Measurable and hypervascular hepatocellular carcinoma on contrast-enhanced CT.
4) Multiple lesion in both lobes of the liver.
5) No tumor thrombus in main or 1st branch of the portal vein.
6) No influence of previous treatments.
7) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
8) Child-Pugh score of A or B.
9) Adequate cardiac, hepatic, renal, respiratory, and bone marrow functions.
10) Ages 20 years and above, under 75 years.
11) Expected survival more than 8 weeks.
12) Written informed consent.
Key exclusion criteria 1) Prior chemotherapy with cisplatin for HCC.
2) Suspicious of extra-hepatic arterial blood supply to lesions on contrast-enhanced CT.
3) Extra-hepatic arterial blood supply to lesions on prior angiography.
4) Surgical reconstruction or endoscopic treatment involving biliary system.
5) Lymphnode metastasis or distant metastasis.
6) Other uncontrolled severe illness.
7) Active infectious disease except viral hepatitis.
8) Active other malignancies.
9) Allergic reaction to iodine contrast material, platinum containing agent, or gelatin containing agent.
10) Pregnant or nursing.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keigo Osuga
Organization Osaka University Graduate School of Medicine
Division name Department of Radiology
Zip code
Address 2-2, Yamadaoka, Suita, Osaka 565-0871, Japan
TEL 06-6879-3434
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yasuaki Arai
Organization JIVROSG, Coordinating Office
Division name Division of Diagnostic Radiology, National Cancer Center Hospital
Zip code
Address 5-1-1,Tsukiji,Chuo-ku,Tokyo,104-0045,Japan
TEL 03-3542-2511
Homepage URL http://jivrosg.umin.jp/
Email jivrosgoffice@ml.res.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
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
2005 Year 08 Month 07 Day

Related information
URL releasing protocol http://jivrosg.umin.jp/
Publication of results Unpublished

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/22922041
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
2005 Year 07 Month 18 Day
Date of IRB
Anticipated trial start date
2005 Year 10 Month 01 Day
Last follow-up date
2009 Year 06 Month 01 Day
Date of closure to data entry
2010 Year 01 Month 01 Day
Date trial data considered complete
2010 Year 01 Month 01 Day
Date analysis concluded
2010 Year 02 Month 01 Day

Other
Other related information

Management information
Registered date
2005 Year 08 Month 07 Day
Last modified on
2012 Year 09 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000090

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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