UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013771 |
|---|---|
| Receipt number | R000015602 |
| Scientific Title | Feasibility study of Epirubicin-Eluting-Bead Embolization for Hepatocellular Carcinoma (JIVROSG-1301) |
| Date of disclosure of the study information | 2014/04/23 |
| Last modified on | 2015/04/22 11:37:49 |
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Basic information
Public title
Feasibility study of Epirubicin-Eluting-Bead Embolization for Hepatocellular Carcinoma (JIVROSG-1301)
Acronym
Feasibility study of DEB-epiDOX for HCC (JIVROSG-1301)
Scientific Title
Feasibility study of Epirubicin-Eluting-Bead Embolization for Hepatocellular Carcinoma (JIVROSG-1301)
Scientific Title:Acronym
Feasibility study of DEB-epiDOX for HCC (JIVROSG-1301)
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility of embolization with epirubicin-Eluting-Bead Embolization for Hepatocellular Carcinoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
arterial embolization with drug eluting beads
Interventions/Control_2
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 or clinically diagnosed HCC (excluding the mixed type)
2) No indication for hepatic resection, liver transplantation or local ablative therapy (radiofrequency ablation, etc.)
3) Hypervascular lesion showing enhancement in the early phase on CT or MRI with bolus contrast injection
4) No tumor thrombus in the first branch or main portal vein
5) Eastern Cooperative Oncology Group performance status of 0 to 2
6) Child-Pugh classification of A or B
7) Adequate hematologic, hepatic, renal, and cardiac function; laboratory tests within two weeks before
registration in the study are defined as:
(1) WBC
(2) Platelet count
(3) Serum bilirubin
8) Patient age 20 years and above
10) Written informed consent
Key exclusion criteria
1) Prior surgical reconstruction or endoscopic treatment of the biliary tract 2) Clinically significant refractory ascites or pleural effusion
3) Severe arterio-portal or arterio-venous shunts in the liver
4) Allergy to contrast medium that precludes angiography
5) Severe, active co-morbidity, defined as follows:
- Uncontrolled cardiac failure, angina and/or rhythm disorders
- Myocardial infarction within the last 6 months
- Renal failure
- Active infection (viral hepatitis is allowed)
- Active gastrointestinal bleeding
- Other active malignant tumor
- Hepatic encephalopathy or severe mental disorder
6) Pregnancy, nursing women, or women of childbearing potential, and men who are sexually active and not willing or able to use medically acceptable forms of contraception
7) Not eligible because of safety issues judged by investigators
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroaki Ishii |
Organization
National Cancer Center Hospital
Division name
Department of Diagnostic Radiology
Zip code
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL
03-5475-5201
ishiihiroakii@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroaki Ishii |
Organization
National Cancer Center Hospital
Division name
Department of Diagnostic Radiology
Zip code
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL
03-5475-5201
Homepage URL
http://jivrosg.umin.jp/
ishiihiroakii@gmail.com
Sponsor or person
Institute
Japan Interventional Radiology In Oncology Study Group(IVROSG)
Institute
Department
Personal name
Funding Source
Organization
Japan Interventional Radiology In Oncology Study Group(IVROSG)
Organization
Division
Category of Funding Organization
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
| 2014 | Year | 04 | Month | 23 | 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
| 2014 | Year | 03 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 24 | Day |
Last follow-up date
| 2014 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2015 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2015 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 21 | Day |
Last modified on
| 2015 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015602
