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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000488
Receipt No. R000000592
Scientific Title A phase II trial of hepatic arterial infusion chemotherapy with cisplatin for advanced hepatocellular carcinoma with portal vein tumor thrombosis
Date of disclosure of the study information 2006/09/12
Last modified on 2009/09/13

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Basic information
Public title A phase II trial of hepatic arterial infusion chemotherapy with cisplatin for advanced hepatocellular carcinoma with portal vein tumor thrombosis
Acronym Hepatic arterial infusion chemotherapy with cisplatin for advanced hepatocellular carcinoma with portal vein tumor thrombosis
Scientific Title A phase II trial of hepatic arterial infusion chemotherapy with cisplatin for advanced hepatocellular carcinoma with portal vein tumor thrombosis
Scientific Title:Acronym Hepatic arterial infusion chemotherapy with cisplatin for advanced hepatocellular carcinoma with portal vein tumor thrombosis
Region
Japan

Condition
Condition Advanced hepatocellular carcinoma with portal vein tumor thrombosis
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the antitumor effect, survival, and toxicity of hepatic arterial infusion chemotherapy with cisplatin for advanced hepatocellular carcinoma with portal vein tumor thrombosis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes response rate
Key secondary outcomes adverse events, survival, and progression free survival

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
Interventions/Control_1 A dose of 65 mg/m2 of cisplatin is administered for 20 to 40 minutes from hepatic artery. Treatment is repeated every 4 to 6 weeks for a maximum of six courses, if there is no evidence of tumor progression or unacceptable toxicity.
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) Advanced hepatocellular carcinoma with confirmation of histological examination or typical computed tomographic, angiographic findings and elevated serum alpha-fetoprotein levels
2) No indication for surgical resection
3) Tumor thrombosis in the main and/or first portal vein
4) Aged 20 years or over
5) An Eastern Cooperative Oncology Group performance status of 0-2
6) Measurable disease
7) Sufficient organ function: WBC>=3,000 /mm3, Hb>=9.0 g/dL, PLT>=50,000 /mm3, Child-Pugh grade A or B, T-Bil<=2.0 mg/dL, AST<=150 U/L, ALT<=150 U/L, Creatinine<=1.1 mg/dL
8) Interval of 4 weeks or over between last treatment and present therapy, and no influence of previous treatments
9) Written informed consent
Key exclusion criteria 1) Prior chemotherapy with cisplatin for hepatocellular carcinoma
2) Prior radiotherapy, transcatheter arterial chemoembolization, and hepatic arterial chemotherapy for portal vein tumor thrombosis of hepatocellular carcinoma
3) Refractory pleural effusion or ascites
4) Distant metastases
5) Allergic reaction to iodine contrast material
6) Severe renal disease
7) Severe heart disease
8) Active infection excluding hepatitis B or C viral infection
9) Active concomitant malignancy
10) Severe mental disorder
11) Severe allergic reaction to drug
12) Pregnant and lactating females; females of childbearing age unless using effective contraception
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masafumi Ikeda, MD.
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, MD.
Organization CDDP HAI Coordinating Office
Division name Hepatobiliary and Pancreatic Oncology Division, National Cancer Center Hospital
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL 03-3542-2511
Homepage URL
Email masikeda@ncc.go.jp

Sponsor
Institute Hepatobiliary and Pancreatic Oncology Division, National Cancer Center Hospital
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
2006 Year 09 Month 12 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2004 Year 11 Month 25 Day
Date of IRB
Anticipated trial start date
2005 Year 01 Month 01 Day
Last follow-up date
2008 Year 01 Month 01 Day
Date of closure to data entry
2008 Year 01 Month 01 Day
Date trial data considered complete
2008 Year 03 Month 01 Day
Date analysis concluded
2008 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 09 Month 12 Day
Last modified on
2009 Year 09 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000592

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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