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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003162
Receipt No. R000003647
Scientific Title A romdomized controlled study of effectiveness between transcatheter arterial chemoembolization with cisplatin and transcatheter arterial chemoembolization with epirubicin for multiple hepatocellular carcinomas
Date of disclosure of the study information 2010/04/01
Last modified on 2013/10/02

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Basic information
Public title A romdomized controlled study of effectiveness between transcatheter arterial chemoembolization with cisplatin and transcatheter arterial chemoembolization with epirubicin for multiple hepatocellular carcinomas
Acronym A romdomized controlled study of effectiveness between CDDP-TACE and EPI-TACE for multiple HCCs
Scientific Title A romdomized controlled study of effectiveness between transcatheter arterial chemoembolization with cisplatin and transcatheter arterial chemoembolization with epirubicin for multiple hepatocellular carcinomas
Scientific Title:Acronym A romdomized controlled study of effectiveness between CDDP-TACE and EPI-TACE for multiple HCCs
Region
Japan

Condition
Condition multiple hepatocellar carcinomas
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare effect of epirubicin-TACE between effect of cisplatin-TACE for patients with multiple HCCs.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Response rate(based on EASL criteria)
Key secondary outcomes Overall survival
Progression free survival
Response rate(based on the General Rules for the Clinical and Pathological Study of Primary Liver Cancer)
Safety

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Epirubicin-TACE
Interventions/Control_2 Cisplatin-TACE
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

Not applicable
Gender Male and Female
Key inclusion criteria 1)Patients with HCC that are histologically or clinically confirmed
2)Patients with multiple HCCs that are diagnosed as stage2-4a and cannot be selected for surgical resection or local ablation
3)Patients without severe tumor thrombosis in the portal vein, hepatic vein and the bile duct
4)Patients under Child-Pugh A or B
5)Patients under PS 0 or 1
6)Patients who fulfill all of the selected criteria below
1.WBC>=3000/mm3
2.Plt>=5x10^4/mm3
3.Hb>=8.0g/dl
4.T-Bil=<3.0mg/dl
5.ALB=<2.8g/dl
6.CRE=<1.2mg/dl
7)Patients who are 20 years and older and who are autonomous independent adults

Key exclusion criteria 1)Patients with another active cancer
2)Patients with extrahepatic metastasis
3)Patients with prior surgical reconstruction of the biliary tract or prior endoscopic treatment of ampulla of vater
4)Patients with clinically significant refractory ascites or pleural effusion
5)Patients with hepatic encephalopathy
6)Patients with severe co-morbidity such as cardiac failure and renal failure
7) Patients who have taken doses of chemotherapeutic agents with cardiac toxicity exceeding a set threshold.
8)Patients with a medical history of severe hypersensitivity
9)Patients who are pregnant, lactating or are suspected to be pregnant.
10)Patients who are concluded to be inappropriate to participate in this study by their physicians
Target sample size 160

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hatano Etsuro
Organization Graduate School of Medicine Kyoto Uinversity
Division name Department of Surgery
Zip code
Address 54 Kawaracho Shogoin, Sakyo-ku, Kyoto
TEL 075-751-4323
Email etsu@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hatano Etsuro
Organization Graduate School of Medicine Kyoto Uinversity
Division name Department of Surgery
Zip code
Address 54 Kawaracho Shogoin, Sakyo-ku, Kyoto
TEL 075-751-4323
Homepage URL
Email etsu@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Surgery, Graduate School of Medicine Kyoto Uinversity
Institute
Department

Funding Source
Organization Department of Surgery, Graduate School of Medicine Kyoto Uinversity
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

Other administrative information
Date of disclosure of the study information
2010 Year 04 Month 01 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
2010 Year 01 Month 05 Day
Date of IRB
Anticipated trial start date
2010 Year 04 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
2010 Year 02 Month 10 Day
Last modified on
2013 Year 10 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003647

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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