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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016834
Receipt No. R000019203
Scientific Title The evaluation of the clinical effect and safety of stereotactic body radiationtherapy for hepatocellularcarcinoma
Date of disclosure of the study information 2015/03/18
Last modified on 2019/04/08

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Basic information
Public title The evaluation of the clinical effect and safety of stereotactic body radiationtherapy for hepatocellularcarcinoma
Acronym Stereotactic body radiationtherapy for hepatocellularcarcinoma
Scientific Title The evaluation of the clinical effect and safety of stereotactic body radiationtherapy for hepatocellularcarcinoma
Scientific Title:Acronym Stereotactic body radiationtherapy for hepatocellularcarcinoma
Region
Japan

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

Objectives
Narrative objectives1 We evaluate the local tumor control, prognosis, and safety of the stereotactic body radiatioterapy combined with transareterial catheter therapy for hepatocellularcarcinoma.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes efficacy
Key secondary outcomes efficacy

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
20 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria (1) hypervascular HCC nodules, each up to 50 mm in diameter; (2) not suitable for the hepatic resection or ablative therapy; (3) Child-Turcotte-Pugh (CTP) score<7.CTP) score<7.
Key exclusion criteria neighboring the Intestinal tract
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuaki Chayama
Organization Hiroshima university
Division name Department of Medicine and Molecular Science
Zip code
Address 1-2-3 Kasumi, Minamiku, Hiroshima
TEL 0822575555
Email chayama@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Aikata
Organization Hiroshima university hospital
Division name Department of Medicine and Molecular Science
Zip code
Address 1-2-3 Kasumi, Minamiku, Hiroshima
TEL 0822575555
Homepage URL
Email aikata@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima university
Institute
Department

Funding Source
Organization Hiroshima university
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 広島大学病院 (広島県)

Other administrative information
Date of disclosure of the study information
2015 Year 03 Month 18 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
2015 Year 02 Month 15 Day
Date of IRB
2012 Year 02 Month 29 Day
Anticipated trial start date
2015 Year 02 Month 15 Day
Last follow-up date
2017 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We perform stereotactic body radiotherapy as additional treatment after the TACE for a local hepatocellular carcinoma (greatest dimension 5cm or less). Further we examine the effectiveness and safety and follow up them after this treatment.


Management information
Registered date
2015 Year 03 Month 18 Day
Last modified on
2019 Year 04 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019203

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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