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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000005782
Receipt No. R000006840
Scientific Title Prospective randomized control study of efficacy of transcatheter arterial chemoembolization (TACE) with Miriplatin vs. Epirubicin for recurrent hepatocellular carcinoma after TACE.
Date of disclosure of the study information 2011/06/15
Last modified on 2018/12/03

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Basic information
Public title Prospective randomized control study of efficacy of transcatheter arterial chemoembolization (TACE) with Miriplatin vs. Epirubicin for recurrent hepatocellular carcinoma after TACE.
Acronym Miripuratin TACE vs. Epirubicin TACE for recurrent hepatocellular carcinoma; Prospective randomized control study.
Scientific Title Prospective randomized control study of efficacy of transcatheter arterial chemoembolization (TACE) with Miriplatin vs. Epirubicin for recurrent hepatocellular carcinoma after TACE.
Scientific Title:Acronym Miripuratin TACE vs. Epirubicin TACE for recurrent hepatocellular carcinoma; Prospective randomized control study.
Region
Japan

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

Objectives
Narrative objectives1 To assess the efficacy of trancatheter arterial chemoembolizaion (TACE) with Miriplatin compared with TACE with Epirubicin.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Tumor response
Key secondary outcomes Overall survival, progression free survival, time to treatment failure, tumor marker change, safety

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Miriplatin TACE
Interventions/Control_2 Epirubicin 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) Histologically proven or clinically diagnosed hepatocellular carcinoma. Number of tumors are up to 10.
2) Patients who have a recurrence after Epirubicin TACE.
3) Patients who fulfill of the inclusion criteria below.
1. PLT >=30000/mm3
2. T.Bil <=3.0mg/dl
3. Cr <=1.5mg/dl
4) Performance status (ECOG) of 0-2
5) The patient without anamunesis of the hypersensitivity to drug utilization
6) Without tumor thrombosis in main portal branch or portal trunk
7) Child-Pugh class A or B.
8) Without pregnant, lactating women or women with suspected pregnancy
9) Patients who were provided written informed consent
Key exclusion criteria 1) Extrahepatic metastasis
2) Patients with active double cancer.
3) Patients with remarkable findings of A-P shunt and/or A-V shunt.
4) Patients with serious allergic symptoms with iodine.
5) Pregnant, lactating women or women with suspected or desired pregnancy
6) Patients who are concluded to be inappropriate to participate in this study by their physicians.
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuya Minami
Organization Kanazawa University Hospital
Division name Department of Radiology
Zip code
Address 13-1 Takara-Machi, Kanazawa, Ishikawa
TEL 076-265-2323
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuya Minami
Organization Kanazawa University Hospital
Division name Department of Radiology
Zip code
Address 13-1 Takara-Machi, Kanazawa, Ishikawa
TEL 076-265-2323
Homepage URL
Email tminami@staff.kanazawa-u.ac.jp

Sponsor
Institute Kanazawa University Hospital
Institute
Department

Funding Source
Organization None
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 金沢大学附属病院(石川県)
Kanazawa University Hospital (Ishikawa)

Other administrative information
Date of disclosure of the study information
2011 Year 06 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 Terminated
Date of protocol fixation
2011 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 02 Month 01 Day
Last follow-up date
2013 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
2011 Year 06 Month 15 Day
Last modified on
2018 Year 12 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006840

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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