UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013870 |
|---|---|
| Receipt number | R000015875 |
| Scientific Title | Phase II Trial of Balloon Occluded Transarterial Chemoembolization with Epirubicin and Ethiodized Oil for Large Advanced Hepatocellular Carcinomas of the Barcelona Clinic Liver Cancer Stage B |
| Date of disclosure of the study information | 2014/05/06 |
| Last modified on | 2014/05/02 06:48:20 |
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Basic information
Public title
Phase II Trial of Balloon Occluded Transarterial Chemoembolization with Epirubicin and Ethiodized Oil for Large Advanced Hepatocellular Carcinomas of the Barcelona Clinic Liver Cancer Stage B
Acronym
B-TACE Large Study
Scientific Title
Phase II Trial of Balloon Occluded Transarterial Chemoembolization with Epirubicin and Ethiodized Oil for Large Advanced Hepatocellular Carcinomas of the Barcelona Clinic Liver Cancer Stage B
Scientific Title:Acronym
B-TACE Large Study
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy and safety of balloon occluded transarterial chemoembolization with epirubicin and ethiodized oil for large advanced hepatocellular carcinomas of the Barcelona Clinic Liver Cancer Stage B, which are out of indications of hepatecomy, local ablation therapy or liver transplantation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Response Rate
Key secondary outcomes
Frequency and levels of adverse effects, change of tumor markers, overall survival, 1-year survival rate, 2-year survival rate, progression free survival
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment | Maneuver |
Interventions/Control_1
balloon occluded transarterial chemoembolization with epirubicin and ethiodized oil
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 as hepatocellular carcinoma (HCC).
2) No prospective candidate for hepatectomy, local ablation therapy or liver transplantation.
3) Tumor size 5cm or larger and less than 12cm, and tumor number 5 or less.
4) Advanced HCC (BCLC stage-B).
5) Child-Pugh score 7 or lower.
6) Age of 20 years or older.
7) ECOG Performance Status of 0.
8) Existence of measurable lesion by modified RECIST.
9) At least 4 weeks passed after the previous therapy of hepatectomy, local ablation therapy or TACE.
10) No major organ failure and all the laboratory data, below are conserved.
11) At least 3 months survival expected.
12) Written informed consent obtained from the patient.
Key exclusion criteria
1) Extrahepatic metastasis.
2) Diagnostic or suspicious lesion of Portal venous invasion, hepatic venous invasion or bile duct invasion.
3) Post ruputred state of hepatocellular carcinoma
4) Remarkable arterio-portal or arterio-venous shunting.
5) Hepatic artery occlusion or major extrahepatic collaterals interfering effective drug delivery.
6) Post biliary reconstruction state.
7) Refractory ascites or pleural effusion.
8) Comorbid diseases as cardiac failure, renal failure, active infection, active gastrointestinal bleeding, active associated cancers, hepatic encephalopathy or uncontrolled psychologic disorders.
9) Fever (more than 38 degrees Celsius)
10) Allergy to contrast media or anthracycline agents.
11) Pregnant or lactating.
12) Other reasons not indicated to this study judged by doctors.
Target sample size
27
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshio Kawauchi |
Organization
National Defense Medical College
Division name
Departmen
Zip code
Address
3-2 Namiki Tokorozawa
TEL
0429-95-1211
kawauchi@ndmc.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiro Horikawa |
Organization
Juntendo University Hospital
Division name
Department of Radiology
Zip code
Address
3-1-3 Hongo Bunkyo-ku Tokyo
TEL
03-5802-1230
Homepage URL
horikawaradivr@gmail.com
Sponsor or person
Institute
Department of Radiology, Juntendo University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Radiology, Juntendo University Hospital
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
| 2014 | Year | 05 | Month | 06 | 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 | 03 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 06 | 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 | 02 | Day |
Last modified on
| 2014 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015875
