International Randomized Study of Transarterial Chemoembolization Versus CyberKnife for Recurrent Hepatocellular Carcinoma
Inclusion Criteria:
- Confirmed hepatocellular carcinoma by one of the following:
- Histopathology
- One radiographic technique that confirms a lesion >=2 cm with arterial
enhancement with washout on delayed phase
- Hepatic lesion in patients for whom surgical resection is not possible or would not
result in an opportunity for cure
- Radiographic evidence of persistent, progressive or recurrent disease in an area
previously treated with TACE. This evaluation should be determined after 6 weeks of
initial TACE
- Multi-specialty evaluation whereby the recurrent liver lesion was deemed by both the
attending radiation oncologist and interventional radiologist amenable to treatment
by the respective modality
- Eligible patients must undergo an IV contrast CT scan of the liver within 6
weeks of enrollment onto the study; a contrast enhanced liver MRI may be
substituted for the IV contrast CT of the liver.
- A recent serum AFP must also be obtained within 4 weeks of enrollment.
- Unifocal liver tumors not to exceed 7.5 cm in greatest axial dimension. Multifocal
lesions will be restricted to lesions that can be treated within a single target
volume within the same liver segment and to an aggregate of 7.5cm as long as the dose
constraints to normal tissue can be met
- Eastern Clinical Oncology Group performance status 0, 1 or 2
- Patients with liver disease classified as Child Pugh class A/B; if Child's class B,
score must be 8 or less
- Albumin >= 2.5 g/dL
- Total bilirubin <= 3 mg/dL
- INR <= 1.5
- Creatinine <= 2.0 mg/dL
- Age >= 18 years old
- Life expectancy>= 6 months
- Ability of the research subject or authorized legal representative to understand and
the willingness to sign a written informed consent document.
Exclusion Criteria:
- Prior radiation for the recurrent liver tumors
- Prior radiotherapy to the upper abdomen
- Prior RFA to index lesion
- Liver transplant
- Tumors >= 7.5 cm in greatest axial dimension
- Portal vein thrombus
- Large varices within 2 cm of index lesion (seen on cross section imaging)
- Contraindication to receiving radiotherapy
- Active gastrointestinal bleed within 2 weeks of study enrollment
- Ascites refractory to medical therapy
- Women who are pregnant
- Administration of any systemic chemotherapy within the last 1 month
- Presence of multifocal lesions located in different lobes of the liver or
extrahepatic metastases
- Participation in another concurrent SYSTEMIC treatment protocol
- Prior history of malignancy other than HCC