UMIN-CTR Clinical Trial

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	Completed
Date of protocol fixation	2010 Year 01 Month 05 Day
Date of IRB	2010 Year 04 Month 01 Day
Anticipated trial start date	2010 Year 04 Month 01 Day
Last follow-up date	2021 Year 03 Month 18 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 02 Month 10 Day
Last modified on	2021 Year 03 Month 18 Day

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