UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009107 |
|---|---|
| Receipt number | 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 13:19:59 |
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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
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
kaz-k@yc4.so-net.ne.jp
Sponsor or person
Institute
Iwate Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010679
