UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005782 |
|---|---|
| Receipt number | 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 17:59:32 |
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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
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
tminami@staff.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006840
