UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005425 |
|---|---|
| Receipt number | R000006345 |
| Scientific Title | A randomized controlled study of effectiveness between transcatheter arterial chemoembolization with fine powder cisplatin (IA-call) and transcatheter chemoembolization with Miriplatin for unresectable hepatocellular carcinomas(multicenter clinical trial PhaseII) |
| Date of disclosure of the study information | 2011/04/12 |
| Last modified on | 2014/10/17 09:12:54 |
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Basic information
Public title
A randomized controlled study of effectiveness between transcatheter arterial chemoembolization with fine powder cisplatin (IA-call) and transcatheter chemoembolization with Miriplatin for unresectable hepatocellular carcinomas(multicenter clinical trial PhaseII)
Acronym
Comparative study between CDDP-TACE and Miriplatin-TACE for unresectable HCC.
Scientific Title
A randomized controlled study of effectiveness between transcatheter arterial chemoembolization with fine powder cisplatin (IA-call) and transcatheter chemoembolization with Miriplatin for unresectable hepatocellular carcinomas(multicenter clinical trial PhaseII)
Scientific Title:Acronym
Comparative study between CDDP-TACE and Miriplatin-TACE for unresectable HCC.
Region
| Japan |
Condition
Condition
Unresectable hepatocellular carcinoma.
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare efficary and safety between Cisplatin-TACE(IA-call)and Miliplatin-TACE(MIRIPLA) for patients with unresectable HCC.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
effica(RR:Response Rate,DCR:Disease Control Rate)
Key secondary outcomes
Adverse events
Overall survival
Local recurrence after the complete regression
TTF:Time to treatment failure
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Make Miriplatin-Lipiodol suspension and infuse it into hepatic artery, followed by Gelpart infusion
Interventions/Control_2
Make Cisplatin-Lipiodol suspension and infuse it into hepatic artery, followed by Gelpart infusion
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) Histological proven or clinically diagnosed hepatocellular carcinoma. All cases are contraindication for resection and local treatment such as RFA and MCT. All cases have the localized measurable lesion.
2) Limited to liver (Tany, N0, M0)
3) Initial case of hepatocellular carcinoma or recurrence in the different region after treatment such as resection, RFA, PEIT, and TACE.
4) At least 4weeks interval is required after the initial treatment of resection, RFA and PEIT.
5) At least 3months interval is required after the initial TACE.
6) Performance Status: 0-2
7) Preserved liver function (Child-Pugh class A or B)
8) Preserved function of main organs (bone marrow, kidney, and heart) and fulfill all of the selected criteria below.
i) T-Bill : =<2.0mg/dl
ii) WBC : >=3000/mm3
iii) PLT : >=5x10^4/mm3
iv) Hb : >= 9.0g/dl
v) Cre: =<1.3mg/ml(Cre:1.5mg/ml and eGFR>=30ml/min/1.7)
vi) BUN : =<25mg/dl
The above mentioned clinical tests should be performed within 2weeks before the registration.
9) Age >=20 yrs.
10) Written informed consent should be obtained.
Key exclusion criteria
1) Tumor thrombus in the main portal vein(VP4).
2) Remarkable arterio-portal shunt and arterio-venous shunt.
3) Uncontrollable ascites or pleural effusion.
4) Previous medical history of severe hypersensitivity.
5) Previous history of treatment using Cisplatin(IA-call) or Miriplatin(MILIPLA).
6) Serious complications as described below (Except chronic hepatitis and liver cirrhosis)
i) Severe heart disease
ii) Myocardial infarction within 6months
iii) Renal failure
iv) Active infection except viral hepatitis
v) Active bleeding from the digestive tract
vi) Another active cancers (besides hepatocellular carcinoma, the double cancers which can decide the prognosis).
vii) Hepatic encephalopathy or severe psychiatric disease.
7) Pregnant women and women suspected of being pregnant.
8) Patients who are concluded to be inappropriate to participate in this study by the lead investigator and other physicians in charge.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ikuta Yoshiaki |
Organization
Japan community health care organization hitoyoshi medical center
Division name
surgery
Zip code
Address
35 oikami-machi hitoyoshi kumamoto 868-8555
TEL
0966-22-2191
iwasaki-yuri@hitoyoshi.jcho.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuri Iwasaki |
Organization
Japan community health care organization hitoyoshi medical center
Division name
Clinical research center
Zip code
Address
35 oikami-machi hitoyoshi kumamoto 868-8555
TEL
0966-22-2191
Homepage URL
iwasaki-yuri@hitoyoshi.jcho.go.jp
Sponsor or person
Institute
Japan community health care organization hitoyoshi medical center
Institute
Department
Personal name
Funding Source
Organization
Japan community health care organization hitoyoshi medical center
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 04 | Month | 12 | 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
| 2010 | Year | 03 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 04 | Month | 12 | Day |
Last modified on
| 2014 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006345
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