UMIN-CTR Clinical Trial

Basic information
Public title	Potential abscopal effect of stereotactic body radiotherapy on the recurrence of hepatocellular carcinoma: An exploratory observation study
Acronym	Effect of stereotactic body radiotherapy on the recurrence of hepatocellular carcinoma: An exploratory observation study
Scientific Title	Stereotactic body radiotherapy and radiofrequency ablation for early hepatocellular carcinoma-A prospective observational study
Scientific Title:Acronym	Stereotactic body radiotherapy and radiofrequency ablation for early hepatocellular carcinoma-A prospective observational study
Region	Japan

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

Objectives
Narrative objectives1	By comparing the local and nonlocal recurrence rate after stereotactic body radiotherapy (SBRT) and radiofrequency abration to early hepatocellular carcionoma (HCC), and by analyzing the association between the post-treatment changes in immunostimulatory serum factors and HCC recurrence, the inhibitory effect of SBRT on HCC recurrence through potential abscopal effect is exploratory evaluated.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Local and nonlocal Recurrence
Key secondary outcomes

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	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) Solitary hepatocellular carcinoma (HCC) no larger than 30 mm in diameter without portal invasion or extrahepatic metastasis (2)HCC diagnosed with early enhancement and late washout by contrast-enhanced computed tomography or by EOB-magnetic resonance imaging (3) Primary, or recurred HCC being detected after longer than 6 months from initial treatament
Key exclusion criteria	(1) Child-Pugh Score C (2) Performance Status 3-4 (3) Pregnant or potentially pregnant female
Target sample size	280

Research contact person
Name of lead principal investigator	1st name Atsumasa Middle name Last name Komori
Organization	National Hospital Organization Nagasaki Medical Center
Division name	Clinical Research Center
Zip code	856-8562
Address	Kubara 2-1001-1, Omura city, Japan
TEL	0957-52-3121
Email	komori.atsumasa.qr@mail.hosp.go.jp

Public contact
Name of contact person	1st name Atsumasa Middle name Last name Komori
Organization	National Hospital Organization Nagasaki Medical Center
Division name	Clinical Research Center
Zip code	856-8562
Address	Kubara 2-1001-1, Omura city, Japan
TEL	0957-52-3121
Homepage URL
Email	komori.atsumasa.qr@mail.hosp.go.jp

Sponsor
Institute	National Hospital Organization Nagasaki Medical Center
Institute
Department

Funding Source
Organization	National Hospital Organization funding for operating expenses
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	National Hospital Organization central institutional review board
Address	Higashigaoka-2-5-21, Meguro ku, Tokyo
Tel	03-5712-5075
Email	700-kenkyu@mail.hosp.go.jp

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

独立行政法人国立病院機構長崎医療センター(長崎県)　 独立行政法人国立病院機構仙台医療センター(宮城県)　 独立行政法人国立病院機構横浜医療センター(神奈川県) 独立行政法人国立病院機構まつもと医療センター(長野県)　 独立行政法人国立病院機構大阪医療センター(大阪府)　 独立行政法人国立病院機構呉医療センター(広島県)　 独立行政法人国立病院機構岡山医療センター(岡山県)　 独立行政法人国立病院機構小倉医療センター(福岡県) 独立行政法人国立病院機構名古屋医療センター(愛知県) 独立行政法人国立病院機構京都医療センター(京都府)　 独立行政法人国立病院機構大阪南医療センター(大阪府)　 独立行政法人国立病院機構嬉野医療センター(佐賀県)　 独立行政法人国立病院機構東京医療センター(東京県)　 独立行政法人国立病院機構熊本医療センター(熊本県)　 独立行政法人国立病院機構別府医療センター(大分県) 独立行政法人国立病院機構渋川医療センター(群馬県)　 独立行政法人国立病院機構旭川医療センター(北海道)　 独立行政法人国立病院機構高崎総合医療センター(群馬県)　 独立行政法人国立病院機構九州がんセンター(福岡県) 独立行政法人国立病院機構愛媛医療センター(愛媛県) 独立行政法人国立病院機構福山医療センター(広島県)

Other administrative information
Date of disclosure of the study information	2019 Year 10 Month 16 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	2019 Year 09 Month 13 Day
Date of IRB	2019 Year 09 Month 13 Day
Anticipated trial start date	2019 Year 10 Month 16 Day
Last follow-up date	2026 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Prospective observational study

Management information
Registered date	2019 Year 10 Month 16 Day
Last modified on	2019 Year 12 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043355