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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020810
Receipt No. R000024024
Scientific Title Phase II study of segmental transcatheter arterial chemoembolization using iodinated oil mixed with cisplatin powder for unresectable hepatocellular carcinoma
Date of disclosure of the study information 2016/01/31
Last modified on 2016/02/03

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Basic information
Public title Phase II study of segmental transcatheter arterial chemoembolization using iodinated oil mixed with cisplatin powder for unresectable hepatocellular carcinoma
Acronym Lip-TACE for HCC
Scientific Title Phase II study of segmental transcatheter arterial chemoembolization using iodinated oil mixed with cisplatin powder for unresectable hepatocellular carcinoma
Scientific Title:Acronym Lip-TACE for HCC
Region
Japan

Condition
Condition hepatocellular carcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the safety and efficacy of subsegmental or segmental transcatheter arterial chemoembolization using a suspension of cisplatin powder mixed with iodized oil for unresectable hepatocellular carcinoma
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes 2-year local disease-free survival rate
Key secondary outcomes safety, time to progression and 2-year overall survival rate

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 One TACE for one HCC. administrated dose; d cm= Dx10 mg
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 unresectable HCC with contraindication of local ablation therapy confirmed histologically or clinically by diagnostic imaging; no extrahepatic metastasis; tumor size less than 10 cm and tumor located in one segmental area or three subsegmental areas; no lingering effects of previous therapy; Eastern Cooperative Oncology Group performance status of 0 to 2; Child-Pugh classification A or B; maintenance of adequate bone marrow, kidney, cardiac function, and meeting clinical laboratory test criteria; age more than 20 years; life expectancy more than 3 months; and provision of written informed consent.
Key exclusion criteria obvious development of feeding artery from an extrahepatic artery (e.g., inferior phrenic artery, inferior adrenal artery, internal mammary artery) to tumor; previous pancreato-biliary surgery or endoscopic sphincteropapillotomy; serious complications other than chronic hepatitis or liver cirrhosis; a history of allergy to iodine-containing agents or contrast media; extrahepatic metastasis; concomitant malignancy; active clinically serious infections; advanced arteriovenous shunt or arterioportal shunt; pregnant or lactating women, or women of childbearing potential; and other serious medical conditions.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideyuki Nishiofuku
Organization Nara Medical University
Division name Radiology
Zip code
Address 840 Shijo-cho Kashihara-city, Nara
TEL 0744-29-8900
Email hmn@naramed-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideyuki Nishiofuku
Organization Nara Medical University
Division name Radiology
Zip code
Address 840 Shijo-cho Kashihara-city, Nara
TEL 0744-29-8900
Homepage URL
Email hmn@naramed-u.ac.jp

Sponsor
Institute Nara Medical University
Institute
Department

Funding Source
Organization Radiology, Nara Medical University
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
2016 Year 01 Month 31 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2005 Year 10 Month 20 Day
Date of IRB
Anticipated trial start date
2005 Year 11 Month 24 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
2016 Year 01 Month 31 Day
Last modified on
2016 Year 02 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024024

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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