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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000005241
Receipt No. R000006230
Scientific Title Prospective randomized trial of preoperative transcatheter arterial chemoembolization for resectable large hepatocellular carcinoma
Date of disclosure of the study information 2011/03/20
Last modified on 2014/12/24

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Basic information
Public title Prospective randomized trial of preoperative transcatheter arterial chemoembolization for resectable large hepatocellular carcinoma
Acronym Randomized trial of preoperative TACE for HCC
Scientific Title Prospective randomized trial of preoperative transcatheter arterial chemoembolization for resectable large hepatocellular carcinoma
Scientific Title:Acronym Randomized trial of preoperative TACE for HCC
Region
Japan

Condition
Condition resectable large hepatocelluar carcinoma ( >5cm )
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To analyze efficacy of preoperative TACE for resectable, >5cm HCC.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes 2-year recurrence free survival rate.
Key secondary outcomes 2-year overall survival rate
Ratio of necrosis after TACE
Change of serum mRNA level
Recurrence site
Resection ratio after TACE

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Preoperative TACE
Interventions/Control_2 Control
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 PS(ECOG Performance Status Scale):0-1
Child-Pugh: A or B
Major organ function (Bone marrow, Heart, Lung, Liver and Kidney) is good for liver surgery.
Written Informed Consent
Key exclusion criteria Recurrence HCC
Active double cancer
Other preoperative chemothreapy and/or radiation (prior to 4 weeks)
Others
Target sample size 66

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroaki Nagano
Organization Osaka University, Graduate School of Medicine
Division name Surgery
Zip code
Address Yamadaoka 2-2(E2), Suita, Osaka
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shogo Kobayashi
Organization Osaka University, Graduate School of Medicine
Division name Surgery
Zip code
Address Yamadaoka 2-2(E2), Suita, Osaka
TEL
Homepage URL http://www.med.osaka-u.ac.jp/pub/gesurg/study/g-k.html
Email

Sponsor
Institute Department of Surgery, Osaka University, Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Surgery, Osaka University, Graduate School of Medicine
Organization
Division
Category of Funding Organization
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
2011 Year 03 Month 20 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
2011 Year 03 Month 11 Day
Date of IRB
Anticipated trial start date
2011 Year 03 Month 01 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
2011 Year 03 Month 12 Day
Last modified on
2014 Year 12 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006230

Research Plan
Registered date File name
2014/12/24 CSGO-HBP-009_CDDP-TACE_プロトコル.docx

Research case data specifications
Registered date File name
2014/12/24 CSGO-HBP-009_CDDP-TACE_CRF.doc

Research case data
Registered date File name


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