UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013204 |
|---|---|
| Receipt number | R000015405 |
| Scientific Title | Randomized control trial of transarterial chemoembolization with miriplatin-lipiodol suspension or drug eluting bead with doxorubicin for hepatocellular carcinoma |
| Date of disclosure of the study information | 2014/05/30 |
| Last modified on | 2017/02/22 11:00:24 |
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Basic information
Public title
Randomized control trial of transarterial chemoembolization with miriplatin-lipiodol suspension or drug eluting bead with doxorubicin for hepatocellular carcinoma
Acronym
Randomized control trial of transarterial chemoembolization with miriplatin-lipiodol suspension or drug eluting bead with doxorubicin for hepatocellular carcinoma
Scientific Title
Randomized control trial of transarterial chemoembolization with miriplatin-lipiodol suspension or drug eluting bead with doxorubicin for hepatocellular carcinoma
Scientific Title:Acronym
Randomized control trial of transarterial chemoembolization with miriplatin-lipiodol suspension or drug eluting bead with doxorubicin for hepatocellular carcinoma
Region
| Japan |
Condition
Condition
hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study is plan to clarify the clinical effecacy by the randomized controlled trial using DE Bead and miriplatin in TACE for hepatocellular carcinoma patients in Japan.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Anti-tumor response
Key secondary outcomes
Progression free survival
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
TACE with miriplatin
Interventions/Control_2
TACE with DC bead
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)Clinically diagnosed as hepatocellular carcinoma patient.
2)Unresectable hepatocellular carcinoma.
3)20 years of age or older.
4)ECOG performance status 0 or 1.
5)Having measurable lesion in the liver.
6)TMN stage 2 or 3
7)Having indication for TACE.
8)Total birilubin<3.0mg/dl, AST and ALT equal to or less than five times the upper limit.
9)Elapsed 4 weeks or more after previous treatment.
10)Obtained written consent from the patient.
11)Child-Pugh score A or B.
12)Possible to perform the study procedure.
13)Obtained written consent from the patient before study.
Key exclusion criteria
1)Having metastasis.
2)Having vascular invasion.
3)Having vascular anormality or AP shunt.
4)Having previous treatment with miriplatin or DC bead.
5)Having previous treatment with sorafenib.
6)Having severe ascites or pleural effusion.
7)Considered as HCC refractory for TACE.
8)Having allergy of contrast agent.
9)Having severe renal failure.
10)Having severe cardiac disease.
11)Having other cancer.
12)Having hemorrhagic varix.
13)Having severe mental disorder.
14)Having severe drug allergy.
15)Having possibility of pregnant or nursing.
16)Deemed inappropriate to perform the study by the physician.
Target sample size
56
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidemi Goto |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan;
TEL
052-744-2166
hgoto@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoji Ishizu |
Organization
Nagoya University Graduate School of Medicine, Aichi, Japan
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL
052-744-2169
Homepage URL
y-ishizu@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine, Aichi, Japan
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
none
Name of secondary funder(s)
none
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
名古屋大学医学部付属病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | Month | 30 | 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
| 2014 | Year | 07 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 02 | Month | 20 | Day |
Last modified on
| 2017 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015405
