Untreated solitary primary hepatocellular carcinoma
Conditions
Interventions
Stereotactic body radiotherapy
Sponsors
STRSPH study group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically or clinically diagnosed untreated solitary primary hepatocellular carcinoma 2)Solitary hepatocellular carcinoma of 1- 5 cm (including vascular invasion) with typical radiological appearance (early enhancement and delayed washout on dynamic CT), without extrahepatic lesions, diagnosed within 60 days before registration during follow up of chronic hepatitis or cirrhosis (UICC 7th T1, T2, and a part of T3bN0M0) 3)Absence of previous local therapies (resection or percutaneous ablation) or transarterial chemoembolization, except for transarterial embolization (without chemotherapy) within 3 months 4)Pre-treatment liver function of Child- Pugh score 7 or less at registration 5)Aged 20-85 at registration 6)Unfit for resection or liver transplantation, or patient denial of these therapies 7)Unfit for percutaneous radiofrequency ablation or patient denial of the therapy 8)ECOG PS: 0-2 9)Met all requirements of dose constraints as defined on treatment planning 10)Well preserved major organ function fulfilling laboratory test limits as below a)White blood cell count: >3000/mm3 b)Platelet count: > 30000/mm3 c)Hemoglobin: > 8.0g/dl d)Total bilirubin: < 2.0mg/dl e)BUN: <35mg/dl f)Serum creatinine: <1.5mg/dl g)PT: >50% 11)Provision of informed consent from the patient
Exclusion criteria
Exclusion criteria: 1)Ascites uncontrollable with medication 2)History of radiation therapy to the lesion of interest 3)Having esophageal varices which are at great risk of bleeding 4)Having active infectious diseases 5)Associated with other malignancies (simultaneous double cancer and heterochronic double cancer with disease-free time within 5 years), excluding carcinoma-in-situ or submucosal carcinoma treated with curative local therapies, glottis cancer staged as T1N0M0, low-risk prostate cancer (T1-2a, Gleason score 2-6 and PSA < 10 ng/ml), Stage I breast cancer, and other malignancies with comparatively favorable prognosis 6)Having interstitial pneumonitis, pulmonary fibrosis or severe respiratory disease such as pulmonary emphysema 7)Associated with mental illness or manifestation complicating study participation 8)Being pregnant or possible conception 9) Miscellaneous inappropriate conditions judged by physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Three-year overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, three-year local control, local recurrence-free survival, three-year intrahepatic recurrence-free survival, three-year extrahepatic (lymph node and distant) metastasis-free survival, three-year proportion of death from hepatic failure, liver function at one and three year, treatment for the first recurrence, incidence of adverse event, incidence of serious adverse event | — |
Countries
Japan
Contacts
Public ContactTomoki Kimura
Hiroshima University Hospital Department of Radiation Oncology
Outcome results
None listed