UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021250 |
|---|---|
| Receipt number | R000024439 |
| Scientific Title | A prospective randomized controlled trial of selective DEB-epiDOX vs. selective conventional TACE for hepatocellular carcinoma focusing on local complete response rate |
| Date of disclosure of the study information | 2016/03/01 |
| Last modified on | 2020/09/02 09:49:00 |
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Basic information
Public title
A prospective randomized controlled trial of selective DEB-epiDOX vs. selective conventional TACE for hepatocellular carcinoma focusing on local complete response rate
Acronym
A randomized controlled trial of selective DEB-TACE vs. cTACE for HCC (JIVROSG-1302:PRESIDENT study)
Scientific Title
A prospective randomized controlled trial of selective DEB-epiDOX vs. selective conventional TACE for hepatocellular carcinoma focusing on local complete response rate
Scientific Title:Acronym
A randomized controlled trial of selective DEB-TACE vs. cTACE for HCC (JIVROSG-1302:PRESIDENT study)
Region
| Japan |
Condition
Condition
Patients with hepatocellular carcinoma who are scheduled to receive selective TACE
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare local complete response of selective TACE with drug eluting beads using epirubicin and selective TACE with gelatine particle and emulsion of lipiodol and epirubicin
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
local complete response rate of treated lesion by selective TACE at 3 month after TACE
Key secondary outcomes
local complete response rate of treated lesion by selective TACE at 1 month after TACE, Adverse events, serious adverse events
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
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
TACE with Drug eluting beads of epirubicin
Interventions/Control_2
TACE with gelatine particle and emulsion of lipiodol and 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Histologically or clinically diagnosed hepatocellular carcinoma
2. No indication for surgical resection, liver transplantation, or local ablation therapy
3. Hypervascular lesion showing enhancement in the early phase on CT or MRI with bolus contrast injection and possible to perform selective TACE
4. No previous treatment for HCC nodules in which TACE is planned
5. Measurable HCC nodules in which TACE is planned
6. Maximum HCC nodule of 5cm or less in which TACE is planned
7. ECOG Performance Status 0-1
8. Child-Pugh A or B
9. Adequate organ function
a. T-Bil<=3.0 mg/dL
b. AST/ALT within 5 times of upper normal limit or 250 IU/L
10. Age of 20 years or over
11. Written informed consent
Key exclusion criteria
1. Tumor thrombosis in portal vein
2. Extrahepatic metastasis
3. Ruptured HCC nodules in which TACE is planned
4. Extrahepatic feeding arteries for HCC nodules in which TACE is planned
5. Prior surgical reconstruction or endoscopic treatment of the biliary tract
6. Clinically significant refractory ascites or pleural effusion
7. Severe arterio-portal or arterio-venous shunts in the liver
8. Allergy to contrast medium that precludes angiography
9. Previously registered patients in this study
10. Severe, active co-morbidity
11. 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
12. Not eligible because of safety issues judged by investigators
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yasuaki |
| Middle name | |
| Last name | Arai |
Organization
National Cancer Center Hospital
Division name
Department of Diagnostic Radiology
Zip code
104-0045
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan
TEL
03-3542-2511
arai-y3111@mvh.biglobe.ne.jp
Public contact
Name of contact person
| 1st name | Masafumi |
| Middle name | |
| Last name | Ikeda |
Organization
National Cancer Center Hospital East
Division name
Department of hepatobiliary & pancreatic oncology
Zip code
277-8577
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan
TEL
04-7133-1111
Homepage URL
masikeda@east.ncc.go.jp
Sponsor or person
Institute
Japan Interventional Radiology In Oncology Study Group(JIVROSG)
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center Research and Development Fund
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Institutional Review Board
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
Tel
03-3542-2511
NCC_IRBoffice@ml.res.ncc.go.jp
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
| 2016 | Year | 03 | 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
440
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
Main results already published
Date of protocol fixation
| 2016 | Year | 01 | Month | 07 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 07 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 11 | 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
| 2016 | Year | 02 | Month | 29 | Day |
Last modified on
| 2020 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024439
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