hepatocellular carcinoma
Conditions
Interventions
By using Cyberknife, a total dose of 40-50 Gy will be delivered in 4 fractions over 4-8 days
Sponsors
no sponsor
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2 year-overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactHiroshi Mayahara
Kobe Minimally-invasive Cancer Center Radiation Oncology
Outcome results
None listed