UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013966 |
|---|---|
| Receipt number | R000016268 |
| Scientific Title | Comparison of the efficacy between DEB(drug-eluting-bead)-TACE and hepasphere with the use of epirubicin :a randomized prospective phase 2 trial |
| Date of disclosure of the study information | 2014/05/15 |
| Last modified on | 2016/05/17 23:14:34 |
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Basic information
Public title
Comparison of the efficacy between
DEB(drug-eluting-bead)-TACE and hepasphere with the use of epirubicin
:a randomized prospective phase 2 trial
Acronym
BHEP
Scientific Title
Comparison of the efficacy between
DEB(drug-eluting-bead)-TACE and hepasphere with the use of epirubicin
:a randomized prospective phase 2 trial
Scientific Title:Acronym
BHEP
Region
| Japan |
Condition
Condition
hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Comparison of the safety and efficacy between DEB-TACE and Hepasphere with the use of epirubicin
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
safety
Key secondary outcomes
Time to local progression
MST
TE
mRESICT
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
| Device,equipment |
Interventions/Control_1
DC bead
Interventions/Control_2
hepasphere
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
patients with histologically or radiographically diagnosed HCC
patients over 20 years old with informed consent form singed
patients must have a life expectancy of at least 6 months
EOCG performanc status 0 or 1
Patients who are recived systemic or
Key exclusion criteria
patients with extrahepatic and metastasis of the lymph node
macroscopic vascular invasion
active serious infection exept for hepatic B or C infection
active cancer
Pregnant or lacting women
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | takuzi torimura |
Organization
kurume university
Division name
gastroenterology
Zip code
Address
67,asahi-machi,kurume-shi,fukuoka,830-0011,Japan
TEL
0942-35-3311
tori@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | shigeo shimose |
Organization
kurume university
Division name
gastroenterology
Zip code
Address
67,asahi-machi,kurume-shi,fukuoka,830-0011,Japan
TEL
0942-35-3311
Homepage URL
shimose_shigeo@med.kurume-u.ac.jp
Sponsor or person
Institute
kurume university
Institute
Department
Personal name
Funding Source
Organization
none
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
久留米大学病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 04 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 05 | Month | 15 | Day |
Last modified on
| 2016 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016268
