UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multicenter prospective phase 2 study of Cyberknife Stereotactic Abrative Radiotherapy for Primary or Recurrent Hepatocellular Carcinoma
Title of the study (Brief title)	C-SAR PRIOR
Region	Japan

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

Objectives
Narrative objectives1	To investigate efficacy and safety of Cyberknife stereotactic abrative radiotherapy for limited primary or recurrent hepatocellular carcinoma
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	2 year-overall survival
Key secondary outcomes	2 year local progression-free ratio, tumor response, 2y-OS by primary or recurrent status, 2y-OS by Child's Classification, 2y-intrahepatic progression-free survival, 2y-hepatic disease-specific survival, 2y-local progression-free ratio by tumor diameter, incidence of severe morbidity

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	By using Cyberknife, a total dose of 40-50 Gy will be delivered in 4 fractions over 4-8 days
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	86 years-old >
Gender	Male and Female
Key inclusion criteria	1) Pathologically or radiologically diagnosed hepatocellular carcinoma 2) Single lesion with 5 cm or less in size 3) Ineligible for surgical resection 4) Ineligible for percutaneous local ablative therapy 5) Liver function with Child-pugh score of 5-6 (class A) or 7 (class B) 6) Normal liver volume of 700ml or more 7) Satisfy the liver tolelance dose 8) Dose not exceed the tolelance dose of surrounding normal tissues 9) ECOG Performance Status of 0-2 10) Indicated for percutaneous fiducial insertion
Key exclusion criteria	1) Uncontrolled ascites 2) Gastric/esophageal varix which needs preventive treatment 3) Tumor thrumbus in main trunk or first branch of portal vein, or IVC 4) Tumor invasion to main trunk of portal vein 5) Case with lymph node or distant metastasis 6) Case with critical co-morbidities 7) Simultaneous active cancer 8) In pregnancy or with expectation of pregnancy 9) Concurrent administration of sorafenib
Target sample size	103

Research contact person
Name of lead principal investigator	Katsuyuki Karasawa
Organization	The Japanease Society of Cyberknife
Division name	Office
Address	O-temachi 2-2-1, Chiyoda-Ku, Tokyo, Japan
TEL	03-6265-1544
Email	aniino@accuray.com

Public contact
Name of contact person	Hiroshi Mayahara
Organization	Kobe Minimally-invasive Cancer Center
Division name	Radiation Oncology
Address	Minatojimanakamachi8-5-1, Chuo-Ku, Kobe, Hyogo, Japan
TEL	078-304-4100
Homepage URL
Email	mayahara@k-mcc.net

Sponsor
Institute	no sponsor
Institute
Department

Funding Source
Organization	Self funding
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	さいたま赤十字病院（埼玉県）、がん感染症センター都立駒込病院（東京都）、国立がん研究センター（東京都）、済生会横浜市東部病院（神奈川県）、春日井サイバーナイフ・リハビリ病院（山梨県）、神戸低侵襲がん医療センター（兵庫県）、長崎みなとメディカルセンター市民病院（長崎県）

Other administrative information
Date of disclosure of the study information	2017 Year 03 Month 07 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 02 Month 09 Day
Anticipated trial start date	2017 Year 03 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 03 Month 02 Day
Last modified on	2017 Year 03 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030307