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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002073
Receipt No. R000002358
Scientific Title Phase II study of combination therapy of cisplatin suspension in lipiodol and 5-fluorouracil hepatic arterial infusion for advanced HCC
Date of disclosure of the study information 2009/07/01
Last modified on 2011/06/16

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Basic information
Public title Phase II study of combination therapy of cisplatin suspension in lipiodol and 5-fluorouracil hepatic arterial infusion for advanced HCC
Acronym The study of NFP for advanced HCC
Scientific Title Phase II study of combination therapy of cisplatin suspension in lipiodol and 5-fluorouracil hepatic arterial infusion for advanced HCC
Scientific Title:Acronym The study of NFP for advanced HCC
Region
Japan

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

Objectives
Narrative objectives1 This study assessed the efficacy of CDDP on lipiodol suspension with 5-FU for patients with HCC measuring more than 5cm in diameter and portal vein tumor thrombosis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Progrssion free survival
Key secondary outcomes Overall survival
response evaluation
complicasion

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 hospitalization therapy administration via the implanted port of Cisplatin/lipiodol suspension(50mg/body,ia,day1,8) and 5-FU(1250mg/body/day, cia day1-5,8-12) into the hepatic artery every two weeks.
outpatient therapy : The case that chemotherapy by the hospitalization finished,leaves the hospital if possible.
Administration via the implanted port of Cisplatin/lipiodol suspension(10~50mg/body,ia,day1)and 5-FU(500~1250mg/body/day,cia,day1-5)into the hepatic artery every two weeks.Repeat 10 courses.
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
30 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1. Histologically or clinically confirmed hepatocellular carcinoma.
2.No indication for transplantation or surgical resection.
3.Portal vein tumor thrombosis(main trunk or first branch) or multinodular tumor and maximum tumor size is >=50mm.
4.Ages 30 to 80 years old.
5.EOCG performance status is 0 or 1.
6.Life expectancy is more than 3 months.
7.Sufficient function of main organ(bone marrow, kidney,heart)and conditions filled the following criteria.
WBC>=2,000/mm3
Hb>=8.5g/dL
Plt>=50,000/mm3
Child-Pugh score<9
T-bil=<2.0mg/dL
Without uncontrolled ascites and hepatic encephalopathy.
S-Cr=<1.5mg/dL or CCr>=50mL/min
Ejection fraction>=45%
PaO2>=60mmHg
8.Written informed consent was obtained
Key exclusion criteria 1.previous chemotherapy or TAE
2.Previous operation or RFA or PEIT within one year
3.Extrahepatic metastasis or nodes metastasis
4.Concurrent infections(without hepatitis virus)
5.Active double cancers
6.Medical history of severe hypersensitivity.
7.Pregnant,lacting women or women with suspected pregnancy.
8.Inappropriate patients for this study judged by physicians.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Michio Sata
Organization Kurume University School of Medicine
Division name Division of Gastroenterology
Zip code
Address 67,Asahi-machi,kurume-city,Fukuoka,830-0011,Japan
TEL 0942-31-7561
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroaki Nagamatsu
Organization Yame General Hospital
Division name Department of Gastroenterology and Hepatology
Zip code
Address 540-2,Takatsuka,Yame-city,Fukuoka,834-0034
TEL 0943-23-4131
Homepage URL
Email ymhp0389@yamehp.jp

Sponsor
Institute Division of Gastroenterology,Kurume University School of Medicine
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
2009 Year 07 Month 01 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
52 cases
PFS=8.5 months
MST=27 months
Tumor Response
response rate=75%
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
2007 Year 05 Month 14 Day
Date of IRB
Anticipated trial start date
2007 Year 05 Month 01 Day
Last follow-up date
2011 Year 04 Month 01 Day
Date of closure to data entry
2011 Year 04 Month 01 Day
Date trial data considered complete
2011 Year 05 Month 01 Day
Date analysis concluded
2011 Year 05 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 06 Month 12 Day
Last modified on
2011 Year 06 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002358

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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