Status:
COMPLETED
Stereotactic Body Radiotherapy for Unresectable Hepatocellular Carcinoma
Lead Sponsor:
Samsung Medical Center
Conditions:
Localized Non-Resectable Adult Hepatocellular Carcinoma
Eligibility:
All Genders
20+ years
Phase:
NA
Brief Summary
1\. Background 1.1. Hepatocellular carcinoma (HCC) HCC is the third most common cause of cancer death globally. It is also the second cause of cancer mortality in Korea, despite the incidence of HCC w...
Eligibility Criteria
Inclusion
- Patients must have a diagnosis of HCC by at least one criterion listed below (KLCSG guideline 2009) 1.1 Pathologically (histologically or cytologically) proven diagnosis of HCC 1.2 Liver nodule in high risk group 1.2.1 If alpha feto protein (AFP)≥200 ng/mL , ≥ 1 typical HCC enhancing pattern on dynamic contrast enhanced CT or MRI 1.2.2 If AFP\<200 ng/mL, ≥2 typical HCC enhancing pattern on dynamic contrast enhanced CT, MRI, and angiography 1.3 ≥ 2 cm nodule in liver cirrhosis (LC), ≥ 1 typical HCC enhancing pattern on dynamic contrast enhanced CT or MRI
- Eastern cooperative oncology group performance status 0 or 1
- Size of the HCC ≤ 3 cm or less
- Age ≥ 20
- Unsuitable for resection or transplant or RFA
- Unsuitable for or refractory to TACE or drug eluting beads (DEB)
- Agreement of study-specific informed consent
- Assessment by radiation oncologist and medical oncologist or hepatologist within 28 days prior to study entry?
- Child-Pugh score A within 14 days prior to study entry
- normal liver (Liver minus gross tumor volume) ≥ 700 cc
- Target is only one viable hepatocellular carcinoma
- Blood work requirements
- Absolute neutrophil count (ANC) ≥ 1,500 /mm3, Platelet ≥ 70,000/mm3, Hgb ≥ 8 g/dl
- Liver function test (LFT): T. bilirubin\<3.0 mg/dL, International normalized ratio (INR) \< 1.7, Albumin ≥ 2.8g/dL, Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT)\< 6 X normal
- Serum creatinine \< 1.5 X normal, or Creatinine clearance rate ≥ 60 mL/min
- Male, consent contraception at least 6 months Childbearing potential woman, consent contraception at least 6 months
- Life expectancy more than 12 weeks
- Stable breathing more than 10 minutes
- Consent to fiducial marker insertion ( if needed )
Exclusion
- Extrahepatic metastasis or malignant nodes
- Pregnant and/or breastfeeding woman
- Macroscopic vascular tumor involvement
- Previous upper abdominal RT history
- Uncontrolled active co-morbidity
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2019
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT01910909
Start Date
August 1 2013
End Date
April 1 2019
Last Update
November 22 2023
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea, 135-710