hepatocellular carcinoma
Conditions
Interventions
Carbon-ion radiation therapy Total dose 60.0 Gy(RBE) 4 fractions
Sponsors
Gunma University Heavy Ion Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) pathollogically or clinically diagnosed hepatocellular carcinoma. 2) The tumor is measurable and tumor size is 3cm or larger and less than 10cm. 3) Absence of major portal vein, inferior vena cava or bile duct invasion. 4) cN0M0 (accrdiong to UICC(International Union Against Cancer) TMN classification of Malignant tumours 7th edition) 5) At least 1 weeks passed after the previous therapy of hepatectomy, local ablation therapy or TACE. 6) Child-Pugh score of the patient is from 5 points to 9 points. 7) Perfomance status of the patient is from 0 to 2. 8) The patient is able to understand the explanation of the clinical trial and written informed concent is obtained.
Exclusion criteria
Exclusion criteria: 1) History of radiation therapy to the lesion of interest. 2) The alimentary tract, major branch of portal vein or major bile duct was adjacent to the target lesion. 3) Patients with any other active malignancies. 4) Patient with severe comorbidity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity Acute toxicity(within 6 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate Late toxicity(6 months or later) | — |
Countries
Japan
Contacts
Public ContactTatsuya Ohno
Gunma University Heavy Ion Medical Center
Outcome results
None listed