UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000012 |
|---|---|
| Receipt number | R000000022 |
| Scientific Title | Hepatic arterial infusion chemotherapy of cisplatin and 5-Fluorouracil versus combined intraarterial 5-Fluorouracil and subcutaneous Interferon-alpha therapy in treating patients with unresectable liver cancer |
| Date of disclosure of the study information | 2005/06/14 |
| Last modified on | 2010/02/10 10:20:35 |
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Basic information
Public title
Hepatic arterial infusion chemotherapy of cisplatin and 5-Fluorouracil versus combined intraarterial 5-Fluorouracil and subcutaneous Interferon-alpha therapy in treating patients with unresectable liver cancer
Acronym
Hepatic arterial chemotherapy (FP versus IFN+5FU) for unresectable liver cancer
Scientific Title
Hepatic arterial infusion chemotherapy of cisplatin and 5-Fluorouracil versus combined intraarterial 5-Fluorouracil and subcutaneous Interferon-alpha therapy in treating patients with unresectable liver cancer
Scientific Title:Acronym
Hepatic arterial chemotherapy (FP versus IFN+5FU) for unresectable liver cancer
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify time to treatment failure and overall survival of hepatic arterial infusion chemotherapy of cisplatin and 5-Fluorouracil versus combined intraarterial 5-Fluorouracil and subcutaneous Interferon-alpha therapy in treating patients with unresectable liver cancer involving inferior vena cava or portal vein
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Time to treatment failure
Incidence of adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Hepatic arterial infusion chemotherapy of cisplatin and 5-Fluorouracil
Continue the protocol as long as possible.
Interventions/Control_2
combined intraarterial 5-Fluorouracil and subcutaneous Interferon-alpha therapy
Continue the protocol as long as possible.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Unresectable liver cancer involving inferior vena cava or main portal vein
Child-Pugh A or B
No previous chemotherapy
Neutrophil count > 1000 /mL, Platelet count > 50000 / mL, Hemoglobin > 8 g/dl, Total bilirubin < 2 times the study center upper limit of normal (ULN), Creatine < the study center ULN, Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 4 times the study center ULN
Baseline performance status must be Eastern Cooperative Oncology Group (ECOG) 0, or 1.
Key exclusion criteria
High risk patient for esophageal varices rupture
Malignant disease except hepatocellular carcinoma
Allergy for 5FU, cisplatin, or interferron
Severe heart disease
psychiatric disorder
Uncontrorable pleural effusion, ascites, or cardiac effusion
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Iwao Ikai |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
Address
54 Kawaracho Shogoin Sakyoku Kyoto
TEL
075-751-3240
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
Address
54 Kawaracho Shogoin Sakyoku Kyoto
TEL
075-751-3240
Homepage URL
etsu@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterological Surgery
Kyoto University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Foundation for Biomedical Research and Innovation
Organization
Division
Category of Funding Organization
Non profit foundation
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
YES
Study ID_1
UHA HCC03-01
Org. issuing International ID_1
Foundation for Biomedical Research and Innovation
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 | 06 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
A total of 29 pts were eligible for the study protocol and randomized. The most commonly reported grade 3 or 4 toxicities were: thrombocytopenia, neutropenia, and AST increase. The median OS of 29 pts was 10.2 months. The median OS of FP and IFN/5FU was 13.2 and 7.8 months.
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 | 01 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2007 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2007 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2007 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2007 | Year | 12 | Month | 01 | Day |
Other
Other related information
Presented at ASCO-GI 2010.
Management information
Registered date
| 2005 | Year | 06 | Month | 14 | Day |
Last modified on
| 2010 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000022
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| Registered date | File name |
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| Registered date | File name |
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