UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030822 |
|---|---|
| Receipt number | R000034406 |
| Scientific Title | A prospective randomized controlled trial of selective conventional TACE vs. drug-eluting beads TACE with epirubicin for patients with hepatocellular carcinoma |
| Date of disclosure of the study information | 2018/02/01 |
| Last modified on | 2021/01/20 20:40:44 |
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Basic information
Public title
A prospective randomized controlled trial of selective conventional TACE vs. drug-eluting beads TACE with epirubicin for patients with hepatocellular carcinoma
Acronym
A randomized controlled trial of selective conventional TACE vs. drug-eluting beads TACE for hepatocellular carcinoma
Scientific Title
A prospective randomized controlled trial of selective conventional TACE vs. drug-eluting beads TACE with epirubicin for patients with hepatocellular carcinoma
Scientific Title:Acronym
A randomized controlled trial of selective conventional TACE vs. drug-eluting beads TACE for hepatocellular carcinoma
Region
| Japan |
Condition
Condition
Patients with hepatocellular carcinoma
who are scheduled to underwent TACE
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare local complete response of selective conventional TACE and drug-eluting beads TACE for hepatocellular carcinoma
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Tumor Response at 3 month after TACE
Key secondary outcomes
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Transcatheter arterial chemoembolization using epirubicin and drug-eluting beads
Interventions/Control_2
Transcatheter arterial chemoembolization using epirubicin/lipiodol emulsion
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 proven or clinically diagnosed hepatocellular carcinoma.
2. No prospective candidate for hepatectomy,
liver transplantation, or local ablation therapy (judged by investigators).
3. Hypervascular lesion showing enhancement in the early phase on CT or MRI with bolus contrast injection.
4. Measurable HCC nodules in which TACE is planned.
5. No previous treatment for HCC nodules in which TACE is planned.
6. Without tumor thrombosis in main portal branch or portal trunk.
7. Performance status (ECOG) of 0 to 2.
8. Child Pugh class A or B.
9. Maximum HCC size >5cm or total number>=4.
10. No major organ failure and all the laboratory data, below are conserved.
1) T.Bil<=3.0 mg/dL
2) WBC>=3,000/mm3
3) PLT>=50,000/mm3
11. Age of 20 years or over.
12. Written informed consent.
Key exclusion criteria
1. Extrahepatic metastasis.
2. Ruptured HCC nodules in which TACE is planned.
3. Prior surgical reconstruction or endoscopic treatment of the biliary tract.
4. Severe arterio portal or arterio venous shunts in the liver.
5. Refractory ascites or pleural effusion.
6. Allergy to contrast medium that precludes angiography.
7. Previously registered patients in this study.
8. 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.
9. Comorbid diseases as cardiac failure, recent myoinfarction, renal failure, active infection, active gastrointestinal bleeding, active associated cancers, hepatic encephalopathy or uncontrolled psychologic disorders, and serious allergy to medicine.
10. Not eligible because of safety issues judged by investigators.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masatoshi Isigami |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2169
masaishi@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Teiji Kuzuya |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2169
Homepage URL
tkuzuya@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Hospital
Department of Gastroenterology and Hepatology
Institute
Department
Personal name
Funding Source
Organization
Nagoya University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
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
| 2018 | Year | 02 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 15 | Day |
Last modified on
| 2021 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034406
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| Registered date | File name |
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