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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026633
Receipt No. R000030583
Scientific Title Efficacy of sequential adjuvant chemolipiodolization on hepatocellular carcinoma: Phase II, open labeled, and historical controlled study
Date of disclosure of the study information 2017/04/01
Last modified on 2019/02/25

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Basic information
Public title Efficacy of sequential adjuvant chemolipiodolization on hepatocellular carcinoma: Phase II, open labeled, and historical controlled study
Acronym Efficacy of sequential adjuvant chemolipiodolization on hepatocellular carcinoma: Phase II, open labeled, and historical controlled study
Scientific Title Efficacy of sequential adjuvant chemolipiodolization on hepatocellular carcinoma: Phase II, open labeled, and historical controlled study
Scientific Title:Acronym Efficacy of sequential adjuvant chemolipiodolization on hepatocellular carcinoma: Phase II, open labeled, and historical controlled study
Region
Japan

Condition
Condition Hepatocellular carcinoma
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Assess the safety and efficacy of sequential chemolipiodolization on reducing intrahepatic recurrence within two years after curative hepatectomy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Recurrence free survival at two years after hepatectomy
Key secondary outcomes Liver function
Recurrence pattern
Recurrence free survival at five years after hepatectomy
Overall survival at two and five years after hepatectomy

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Sequential chemolipiodolization (at 3,6,and 12 month after hepatectomy)
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)Performance status 0~2 at 3 month after hepatectomy
2)Child Pugh A/B at 3 month after hepatectomy
3)Well maintained bone marrow and renal function at 3 month after hepatectomy
/WBC count;1,000~12,0000/mm3
/Platelet count;>=50,000/mm3
/Hemoglobin;>=10.0g/dL
/Serum creatinine level;<=1.5mg/dL
4)Written informed concent
Key exclusion criteria 1)History of iodine-based contrast enhancement allergy
2)History of another malignant disease within the past 5 years
Target sample size 95

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaki Ueno
Organization Wakayama Medical University
Division name Second Department of Surgery
Zip code
Address 811-1 Kimiidera, Wakayama
TEL 073-441-0613
Email ma@wakayama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masaki Ueno
Organization Wakayama Medical University
Division name Second Department of Surgery
Zip code
Address 811-1 Kimiidera, Wakayama
TEL 073-441-0613
Homepage URL
Email ma@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University
Institute
Department

Funding Source
Organization Wakayama 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
2017 Year 04 Month 01 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 Completed
Date of protocol fixation
2012 Year 11 Month 14 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 15 Day
Last follow-up date
2018 Year 11 Month 30 Day
Date of closure to data entry
2018 Year 12 Month 28 Day
Date trial data considered complete
2018 Year 12 Month 28 Day
Date analysis concluded
2019 Year 02 Month 28 Day

Other
Other related information

Management information
Registered date
2017 Year 03 Month 21 Day
Last modified on
2019 Year 02 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030583

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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