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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026374
Receipt No. R000030307
Scientific Title Multicenter prospective phase 2 study of Cyberknife Stereotactic Abrative Radiotherapy for Primary or Recurrent Hepatocellular Carcinoma
Date of disclosure of the study information 2017/03/07
Last modified on 2017/03/02

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Basic information
Public title Multicenter prospective phase 2 study of Cyberknife Stereotactic Abrative Radiotherapy for Primary or Recurrent Hepatocellular Carcinoma
Acronym C-SAR PRIOR
Scientific Title Multicenter prospective phase 2 study of Cyberknife Stereotactic Abrative Radiotherapy for Primary or Recurrent Hepatocellular Carcinoma
Scientific Title:Acronym 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
1st name
Middle name
Last name Katsuyuki Karasawa
Organization The Japanease Society of Cyberknife
Division name Office
Zip code
Address O-temachi 2-2-1, Chiyoda-Ku, Tokyo, Japan
TEL 03-6265-1544
Email aniino@accuray.com

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Mayahara
Organization Kobe Minimally-invasive Cancer Center
Division name Radiation Oncology
Zip code
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)

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 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

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
2017 Year 02 Month 09 Day
Date of IRB
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

Other
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

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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