Transarterial Chemoembolization vs CyberKnife for Recurrent Hepatocellular Carcinoma

This is an interventional treatment trial for Carcinoma, Hepatocellular Read More

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