UMIN-CTR Clinical Trial

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
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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
Last 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
1st 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
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IRB Contact (For public release)
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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
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Results
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Baseline Characteristics
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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