UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008710 |
|---|---|
| Receipt number | R000010235 |
| Scientific Title | Randomized phase II study comparing pegylated interferon alpha-2b combined with intra-arterial 5-fluorouracil and sorafenib alone for advanced hepatocellular carcinoma |
| Date of disclosure of the study information | 2012/08/17 |
| Last modified on | 2012/11/08 13:18:44 |
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Basic information
Public title
Randomized phase II study comparing pegylated interferon alpha-2b combined with intra-arterial 5-fluorouracil and sorafenib alone for advanced hepatocellular carcinoma
Acronym
Comparing pegylated interferon alpha-2b combined with 5-fluorouracil and sorafenib for advanced hepatocellular carcinoma
Scientific Title
Randomized phase II study comparing pegylated interferon alpha-2b combined with intra-arterial 5-fluorouracil and sorafenib alone for advanced hepatocellular carcinoma
Scientific Title:Acronym
Comparing pegylated interferon alpha-2b combined with 5-fluorouracil and sorafenib for advanced hepatocellular carcinoma
Region
| Japan |
Condition
Condition
advanced hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In this study, we evaluated the efficacy of combined 5-FU and PEG-IFN alpha-2b, and compared outcomes between advanced HCC patients with PVTT treated using sorafenib.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression free survival
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Enrolled patients will be randomly assigned to receive combined 5-FU and PEG-IFN alpha-2b or sorafenib.
In the 5-FU and PEG-IFN alpha -2b group, after insertion of the drug delivery system, patients received arterial infusion of chemotherapeutic agents via the injection port. Patients are treated with subcutaneous administration of PEG-IFN alpha-2b (PegIntron; Schering-Plough, Osaka, Japan) and intra-arterial infusion of 5-FU (Kyowa Hakko, Tokyo, Japan). One treatment cycle lasts 4 weeks. PEG-IFN alpha-2b dose is weight-adjusted and administered subcutaneously on day 1 of every week. Administration of 5-FU (250 mg/day) into the hepatic artery for 5 h via mechanical infusion pump is performed on days 1-5 of every week.
We will compare the early response to the therapy, progression free survival (PFS) and the cumulative survival rate between these two groups for thee years.
Interventions/Control_2
In the sorafenib group, patients are treated using continuous oral treatment with 400-800 mg of sorafenib (consisting of two 100-200 mg tablets) twice daily
We will compare the early response to the therapy, progression free survival (PFS) and the cumulative survival rate between these two groups for thee years.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Eligibility criteria for treatment were as follows: 1) Portal vein tumor thrombosis (PVTT) grade Vp2-Vp4; 2) no indications for radiotherapy, surgical resection or nonsurgical interventions such as radiofrequency ablation (RFA), microwave coagulation therapy (MCT), percutaneous ethanol injection (PEI) or trans-hepatic arterial chemoembolization (TACE); 3) age >20 years; 4) Eastern Cooperative Oncology Group (ECOG) performance status (PS)4 level 0-2; 5) no uncontrollable ascites or pleural effusion; 6) platelet count >50000/mm3, leukocyte count >2000/l, total bilirubin <3 mg/dl, and serum creatinine <1.5 mg/dl; and 7) chronic hepatitis (CH) or compensated liver cirrhosis (LC) with a Child-Pugh class of A or B.
Key exclusion criteria
Exclusion criteria for treatment were as follows:1) pregnancy women 2) patients who had allergic disorder and severe disease
Target sample size
100
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
Japanese foundation for multidisciplinary treatment of cancer
Organization
Division
Category of Funding Organization
Non profit foundation
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 | 08 | Month | 17 | 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
| 2009 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 01 | Month | 01 | 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 | 08 | Month | 17 | 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=R000010235
