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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000013870
Receipt No. 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

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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
Email 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
Email horikawaradivr@gmail.com

Sponsor
Institute Department of Radiology, Juntendo University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015875

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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