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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003917
Receipt No. R000004440
Scientific Title Randomised phase 2 trial of hepatic arterial chemotherapy with cisplatin and 5-FU versus sorafenib in patients with advanced unresectable hepatocellulare carcinoma
Date of disclosure of the study information 2010/07/15
Last modified on 2014/01/15

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Basic information
Public title Randomised phase 2 trial of hepatic arterial chemotherapy with cisplatin and 5-FU versus sorafenib in patients with advanced unresectable hepatocellulare carcinoma
Acronym Evaluation of clinical effects of NFP therapy and sorafenib for advanced HCC
Scientific Title Randomised phase 2 trial of hepatic arterial chemotherapy with cisplatin and 5-FU versus sorafenib in patients with advanced unresectable hepatocellulare carcinoma
Scientific Title:Acronym Evaluation of clinical effects of NFP therapy and sorafenib for advanced HCC
Region
Japan

Condition
Condition unresectable advanced hepatocellular carcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluation of efficacy of intra-arterial combination therapy ofcisplatin suspension in lipiodol and 5-FU for patients with unresectable advanced hepatocellular carcinoma
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes time to progression

therapeutic efficacy
Key secondary outcomes overall survival

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 5-FU+CDDP with lipiodol
Interventions/Control_2 sorafenib
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 1) unresectable HCC
2) Child-Pugh class A
3) Performance status: ECOG 0-1
4) no influence of prior therapy
5) Serum creatinine; less than 1.5 mg/dl,
WBC: more than 2000, Total bilirubine: less than 2 mg/dl , no uncontrolable ascites, no hepatic encephalopathy, Platelet: more than 50,000, Hb: more than 8.5 g/dl,
Key exclusion criteria 1) extrahepatic metastasis
2) pregnant woman
3) drug allergy
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Michio Sata
Organization Kurume University, School od Medicine,
Division name Department of Medicine, Division of Gastroenterology
Zip code
Address 67 Asahi-machi, Kurume City, Japan
TEL 0942-31-7561
Email tori@med.kurume-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takuji Torimura
Organization Kurume University, School od Medicine
Division name Department of Medicine, Division of Gastroenterology
Zip code
Address 67 Asahi-machi, Kurume City, Japan
TEL 0942-31-7561
Homepage URL
Email tori@med.kurume-u.ac.jp

Sponsor
Institute Kurume University, School od Medicine Department of Medicine, Division of Gastroenterology
Institute
Department

Funding Source
Organization Kurume University, School od Medicine Department of Medicine, Division of Gastroenterology
Organization
Division
Category of Funding Organization Self funding
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 久留米大学病院(福岡県)

Other administrative information
Date of disclosure of the study information
2010 Year 07 Month 15 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 08 Month 31 Day
Date of IRB
Anticipated trial start date
2009 Year 09 Month 01 Day
Last follow-up date
2015 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 07 Month 15 Day
Last modified on
2014 Year 01 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004440

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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