solitary primary hepatocellular carcinoma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) histologically-confirmed or image-diagnosed solitary primary HCC staged as T1N0M0 (UICC TNM 7th ed.) 2) no history of previous HCC 3) patient refusal of surgery or radiofrequency ablation 4) no previous radiotherapy around the lesion 5) age: 20-80 years old 6) ECOG-PS: 0-1 7) Child-Pugh classification A5, 6 or B7 8) dose constraints of the organs at risk achievable 9) tumor diameter < 12 cm 10) written informed consent
Exclusion criteria
Exclusion criteria: 1)pregnancy or lactation 2)severe psychological disorders 3)active and uncontrolled infection 4)Other cancers within 5 years 5)continuous systemic administration (oral or intravenous) of steroids 6)esophageal varix at high risk of bleeding (F3, Rc ++ or higher) 7)portal vein tumor thrombosis 8)cases in which the doctor is judged inappropriate for medical, psychological or other reasons other than the above
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| local control rate, progression free survival,response rate,incidence of grade 3 or higher adverse events,change of quality of life (QOL) | — |
Countries
Japan
Contacts
Nagoya City West Medical Center,Nagoya Proton Therapy Center Radiation oncology