Unique ID issued by UMIN | UMIN000026374 |
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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 |
Multicenter prospective phase 2 study of Cyberknife Stereotactic Abrative Radiotherapy for Primary or Recurrent Hepatocellular Carcinoma
C-SAR PRIOR
Multicenter prospective phase 2 study of Cyberknife Stereotactic Abrative Radiotherapy for Primary or Recurrent Hepatocellular Carcinoma
C-SAR PRIOR
Japan |
hepatocellular carcinoma
Hepato-biliary-pancreatic medicine | Radiology |
Malignancy
NO
To investigate efficacy and safety of Cyberknife stereotactic abrative radiotherapy for limited primary or recurrent hepatocellular carcinoma
Safety,Efficacy
2 year-overall survival
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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
NO
NO
Institution is not considered as adjustment factor.
NO
No need to know
1
Treatment
Device,equipment |
By using Cyberknife, a total dose of 40-50 Gy will be delivered in 4 fractions over 4-8 days
20 | years-old | <= |
86 | years-old | > |
Male and Female
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
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
103
1st name | |
Middle name | |
Last name | Katsuyuki Karasawa |
The Japanease Society of Cyberknife
Office
O-temachi 2-2-1, Chiyoda-Ku, Tokyo, Japan
03-6265-1544
aniino@accuray.com
1st name | |
Middle name | |
Last name | Hiroshi Mayahara |
Kobe Minimally-invasive Cancer Center
Radiation Oncology
Minatojimanakamachi8-5-1, Chuo-Ku, Kobe, Hyogo, Japan
078-304-4100
mayahara@k-mcc.net
no sponsor
Self funding
Self funding
NO
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)
2017 | Year | 03 | Month | 07 | Day |
Unpublished
Open public recruiting
2017 | Year | 02 | Month | 09 | Day |
2017 | Year | 03 | Month | 07 | Day |
2017 | Year | 03 | Month | 02 | Day |
2017 | Year | 03 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030307
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