UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003162 |
|---|---|
| Receipt number | R000003647 |
| Scientific Title | A romdomized controlled study of effectiveness between transcatheter arterial chemoembolization with cisplatin and transcatheter arterial chemoembolization with epirubicin for multiple hepatocellular carcinomas |
| Date of disclosure of the study information | 2010/04/01 |
| Last modified on | 2021/03/18 09:59:32 |
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Basic information
Public title
A romdomized controlled study of effectiveness between transcatheter arterial chemoembolization with cisplatin and transcatheter arterial chemoembolization with epirubicin for multiple hepatocellular carcinomas
Acronym
A romdomized controlled study of effectiveness between CDDP-TACE and EPI-TACE for multiple HCCs
Scientific Title
A romdomized controlled study of effectiveness between transcatheter arterial chemoembolization with cisplatin and transcatheter arterial chemoembolization with epirubicin for multiple hepatocellular carcinomas
Scientific Title:Acronym
A romdomized controlled study of effectiveness between CDDP-TACE and EPI-TACE for multiple HCCs
Region
| Japan |
Condition
Condition
multiple hepatocellar carcinomas
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare effect of epirubicin-TACE between effect of cisplatin-TACE for patients with multiple HCCs.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate(based on EASL criteria)
Key secondary outcomes
Overall survival
Progression free survival
Response rate(based on the General Rules for the Clinical and Pathological Study of Primary Liver Cancer)
Safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
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
Epirubicin-TACE
Interventions/Control_2
Cisplatin-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)Patients with HCC that are histologically or clinically confirmed
2)Patients with multiple HCCs that are diagnosed as stage2-4a and cannot be selected for surgical resection or local ablation
3)Patients without severe tumor thrombosis in the portal vein, hepatic vein and the bile duct
4)Patients under Child-Pugh A or B
5)Patients under PS 0 or 1
6)Patients who fulfill all of the selected criteria below
1.WBC>=3000/mm3
2.Plt>=5x10^4/mm3
3.Hb>=8.0g/dl
4.T-Bil=<3.0mg/dl
5.ALB=<2.8g/dl
6.CRE=<1.2mg/dl
7)Patients who are 20 years and older and who are autonomous independent adults
Key exclusion criteria
1)Patients with another active cancer
2)Patients with extrahepatic metastasis
3)Patients with prior surgical reconstruction of the biliary tract or prior endoscopic treatment of ampulla of vater
4)Patients with clinically significant refractory ascites or pleural effusion
5)Patients with hepatic encephalopathy
6)Patients with severe co-morbidity such as cardiac failure and renal failure
7) Patients who have taken doses of chemotherapeutic agents with cardiac toxicity exceeding a set threshold.
8)Patients with a medical history of severe hypersensitivity
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
160
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hatano Etsuro |
Organization
Graduate School of Medicine Kyoto Uinversity
Division name
Department of Surgery
Zip code
Address
54 Kawaracho Shogoin, Sakyo-ku, Kyoto
TEL
075-751-4323
etsu@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hatano Etsuro |
Organization
Graduate School of Medicine Kyoto Uinversity
Division name
Department of Surgery
Zip code
Address
54 Kawaracho Shogoin, Sakyo-ku, Kyoto
TEL
075-751-4323
Homepage URL
etsu@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Surgery, Graduate School of Medicine Kyoto Uinversity
Institute
Department
Personal name
Funding Source
Organization
Department of Surgery, Graduate School of Medicine Kyoto Uinversity
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
| 2010 | Year | 04 | Month | 01 | 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 | 01 | Month | 05 | Day |
Date of IRB
| 2010 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 18 | 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 | 02 | Month | 10 | Day |
Last modified on
| 2021 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003647
