UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004790 |
|---|---|
| Receipt number | R000005700 |
| Scientific Title | Prospective randomized study of efficacy of trancatheter arterial chemoembolizaion with miriplatin for hepatocellular carcinoma |
| Date of disclosure of the study information | 2010/12/24 |
| Last modified on | 2015/12/24 10:29:53 |
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Basic information
Public title
Prospective randomized study of efficacy of trancatheter arterial chemoembolizaion with miriplatin for hepatocellular carcinoma
Acronym
Prospective randomized study of efficacy of trancatheter arterial chemoembolizaion with miriplatin for hepatocellular carcinoma
Scientific Title
Prospective randomized study of efficacy of trancatheter arterial chemoembolizaion with miriplatin for hepatocellular carcinoma
Scientific Title:Acronym
Prospective randomized study of efficacy of trancatheter arterial chemoembolizaion with miriplatin for hepatocellular carcinoma
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 and safety 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
Time to progression
Key secondary outcomes
Response rate
Safety
Overall survival
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
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 epirubicin
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients with HCC that are histologically or clinically confirmed, unsuitable for resection or locoregional therapy.
2) TNM stage 2 or 3.
3) Patients with HCC that show arterial phase enhancement.
4) Child-Pugh class A or B.
5) History of treatment for HCC within previous 3 months.
6) A life expectancy of 3 months or more.
7) Performance status score (ECOG) of 2 or less.
8) Patients who fulfill of the inclusion criteria below.
1. WBC >=2000/mm3
2. PLT >=50000/mm3
3. Hb >=8.0g/d/dl
4.T.Bil <=3.0mg/dl
5. PT >=40%
6. AST, ALT <=5 x the upper limit of the normal range.
7. Cr <=the upper limit of the normal range.
9) Patients who were provided written informed consent.
Key exclusion criteria
1) Vascular invasion or bile duct invasion.
2) Extrahepatic metastasis.
3) Major arterioportal shunt in the liver.
4) Combination with locoregional therapy.
5) Hepatic encephalopathy or refractory ascites.
6) Adjuvant therapy with IFN, Vit A or anti cancer drug.
7) Patients who have medical history of hypersensitivity of iodine or contrast media.
8) Patients who have severe thyroid disease.
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
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yusuke Okuwaki |
Organization
Kitasato University East Hospital
Division name
Department of Gastroenterology
Zip code
Address
2-1-1 Asamizodai, Minami-ku, Sagamihara
TEL
042-748-9111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yusuke Okuwaki |
Organization
Kitasato University East Hospital
Division name
Department of Gastroenterology
Zip code
Address
2-1-1 Asamizodai, Minami-ku, Sagamihara
TEL
042-748-9111
Homepage URL
okuyu@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University Scool of Medicine, Department of Gastroenterology
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
北里大学東病院
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 12 | Month | 24 | 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 | 05 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 06 | Month | 30 | 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 | 12 | Month | 24 | Day |
Last modified on
| 2015 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005700
