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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009107
Receipt No. R000010679
Scientific Title A clinical study on safety and efficacy of combined intraarterial cisplatin and 5-fluorouracil with systemic pegylated interferon alfa-2b for advanced hepatocellular carcinoma
Date of disclosure of the study information 2012/10/13
Last modified on 2012/11/08

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Basic information
Public title A clinical study on safety and efficacy of combined intraarterial cisplatin and 5-fluorouracil with systemic pegylated interferon alfa-2b for advanced hepatocellular carcinoma
Acronym A combination therapy of CDDP / 5-FU / PEG-IFN alfa-2b for advanced hepatocellular carcinoma. : study of safety and efficacy
Scientific Title A clinical study on safety and efficacy of combined intraarterial cisplatin and 5-fluorouracil with systemic pegylated interferon alfa-2b for advanced hepatocellular carcinoma
Scientific Title:Acronym A combination therapy of CDDP / 5-FU / PEG-IFN alfa-2b for advanced hepatocellular carcinoma. : study of safety and efficacy
Region
Japan

Condition
Condition hepatocellular carcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate on safety and efficacy of combination therapy of intraarterial cisplatin / 5-fluorouracil with systemic pegylated interferon alfa-2b in patients with advanced hepatocellular carcinoma
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Efficacy
Key secondary outcomes

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 Cisplatin (IA-call; Nippon Kayaku Company Ltd.,Tokyo,Japan) : Administrated at a dose of 20mg/m2 by hepatic arterial infusion on days 1 and 15. 5-FU (Kyowa Hakko, Tokyo, Japan) : Administrated at a dose of 250mg/body into hepatic artery for 5 h via mechanical infusion pump on days 1-5 of every a week. PEG-IFN alpha-2b (PegIntron; Schering-Plough, Osaka, Japan) :Administrated at a dose of 50-100ug/body in subcutaneously on day 1 of every a week. One treatment cycle lasts 4 weeks and the withdrawal period is 2 weeks to 4 weeks.
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
70 years-old >=
Gender Male and Female
Key inclusion criteria 1.Age 20-70 years
2.Histologically or clinically confirmed hepatocellular carcinoma
3.Patients with vascular invasion than Vp3
4.Written informed consent was obtained
5.Granulocyte>1500/mm3
6.Hemoglobin>8.5g/dL
7.AST>100
8.ALT>100
9.Total serum bilirubin<2mg/dL
10.Platelet count>80000/uL
11.Serum creatinine<1.5mg/dL
12.PS 0-1
Key exclusion criteria 1. Pregnant or breast-feeding patients.
2. Patients with hypersensitivity to Pt-drug and IFN
3. Severe complication
4. Patients with interstitial pneumonia or a history
5. Patients with central nervous system disorders , the depression or a history
6. Inappropriate patients for this study judged by physicians.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiro Kasai
Organization Iwate Medical University
Division name Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
Address Uchimaru 19-1, Morioka, Iwate 020-8505, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Iwate Medical University
Division name Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
Address
TEL
Homepage URL
Email kaz-k@yc4.so-net.ne.jp

Sponsor
Institute Iwate Medical University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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
2012 Year 10 Month 13 Day

Related information
URL releasing protocol
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 Open public recruiting
Date of protocol fixation
2012 Year 10 Month 13 Day
Date of IRB
Anticipated trial start date
2012 Year 10 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 10 Month 13 Day
Last modified on
2012 Year 11 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010679

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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