International Randomized Study of Transarterial Chemoembolization Versus CyberKnife® for Recurrent Hepatocellular Carcinoma

Inclusion Criteria:

- Confirmed hepatocellular carcinoma by one of the following:

1. Histopathology

2. 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

1. 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 contrast liver CT

2. A recent serum AFP must 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 7.5 cm as long as the
dose constraints to normal tissue can be met.

- Eastern Clinical Oncology Group performance status 0, 1 or 2 (Appendix I).

- Patients with liver disease classified as Child Pugh class A/B, if Child's class B,
score must be 8 or less.

- Life expectancy >= 6 months

- Age >= 18 years old

- Albumin >= 2.5 g/dL

- Total Bilirubin <= 3 mg/dL

- INR <= 1.5

- Creatinine <= 2.0 mg/dL

- Both men and women and members of all races and ethnic groups are eligible for this
study

- 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 tumor

- Prior radiotherapy to the upper abdomen

- Prior RFA to index lesion

- Liver transplant

- Tumors greater than 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 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