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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000012
Receipt No. 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

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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
Email

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
Email etsu@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Gastroenterological Surgery
Kyoto University Graduate School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000022

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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