UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000049 |
|---|---|
| Receipt number | 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 13:23:15 |
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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
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/
jivrosgoffice@ml.res.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
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000090
