UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Stereotactic body radiation therapy for hepatocellular carcinoma.
Title of the study (Brief title)	Stereotactic body radiation therapy for hepatocellular carcinoma.
Region	Japan

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

Objectives
Narrative objectives1	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.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Local tumor control rate, safety
Key secondary outcomes	overall survival rate, disease free survival rate

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.
Key exclusion criteria	neighboring the Intestinal tract
Target sample size	200

Research contact person
Name of lead principal investigator	Kazuaki Chayama
Organization	Hiroshima university
Division name	Department of Medicine and Molecular Science
Address	1-2-3 Kasumi, Minamiku, Hiroshima
TEL	082-257-5555
Email	chayama@hiroshima-u.ac.jp

Public contact
Name of contact person	Hiroshi Aikata
Organization	Hiroshima university
Division name	Department of Medicine and Molecular Science
Address	1-2-3 Kasumi, Minamiku, Hiroshima
TEL	082-257-5555
Homepage URL
Email	aikata@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima university hospital
Institute
Department

Funding Source
Organization	Hiroshima university hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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）

Other administrative information
Date of disclosure of the study information	2012 Year 07 Month 23 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 03 Month 16 Day
Anticipated trial start date	2012 Year 04 Month 01 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry	2016 Year 03 Month 31 Day
Date trial data considered complete	2017 Year 03 Month 31 Day
Date analysis concluded	2017 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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	2012 Year 07 Month 23 Day
Last modified on	2017 Year 10 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009993