UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026374
Receipt number 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 20:45:37

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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 or person

Institute

no sponsor

Institute

Department

Personal name



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

Value
https://center6.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