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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036081
Receipt No. R000041109
Scientific Title Radiofrequency ablation (RFA) versus stereotactic body radiotherapy (SBRT) for single hepatocellular carcinoma: A prospective observational study
Date of disclosure of the study information 2019/03/05
Last modified on 2019/03/05

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Basic information
Public title Radiofrequency ablation (RFA) versus stereotactic body radiotherapy (SBRT) for single hepatocellular carcinoma: A prospective observational study
Acronym RFA versus SBRT for single HCC
Scientific Title Radiofrequency ablation (RFA) versus stereotactic body radiotherapy (SBRT) for single hepatocellular carcinoma: A prospective observational study
Scientific Title:Acronym RFA versus SBRT for single HCC
Region
Japan

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

Objectives
Narrative objectives1 SBRT has been reported to have high local control rate and safety for HCC, but no studies so far have compared SBRT and RFA from the viewpoint of influence on liver function. The purpose of this study is to compare RFA and SBRT in this respect, as well as local control rate, and to clarify the advantages and disadvantages of each treatment.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Changes of ALBI score (comparison between baseline and 3 months after RFA/SBRT)
Key secondary outcomes Local recurrence free survival
Best treatment effect
Recurrence
Overall survival
Changes of ALBI score (6, 9, and 12months)
Changes of Child-Pugh score (3, 6, 9, and 12 months)
Time to liver function worsening
Adverse events

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Single, 3cm or smaller, and no metastasis
Life expectancy of 3 months or longer
Key exclusion criteria Child-Pugh score of 10 or more
Palliative radiotherapy
Informed consent not obtained
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masayuki Ueno
Organization Kurashiki Central Hospital
Division name Department of Gastroenterology and Hepatology
Zip code
Address 1-1-1 Miwa, Kurashiki, Okayama, Japan
TEL 0864220210
Email mu13951@kchnet.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masayuki Ueno
Organization Kurashiki Central Hospital
Division name Department of Gastroenterology and Hepatology
Zip code
Address 1-1-1 Miwa, Kurashiki, Okayama, Japan
TEL 0864220210
Homepage URL
Email mu13951@kchnet.or.jp

Sponsor
Institute Department of Gastroenterology and Hepatology, Kurashiki Central Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
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
2019 Year 03 Month 05 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
2018 Year 02 Month 27 Day
Date of IRB
Anticipated trial start date
2019 Year 03 Month 05 Day
Last follow-up date
2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2023 Year 03 Month 31 Day

Other
Other related information None

Management information
Registered date
2019 Year 03 Month 05 Day
Last modified on
2019 Year 03 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041109

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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