Fusion Guided Thermal Ablation Combined With External Beam Radiation for Hepatic Neoplasms

Inclusion Criteria

- INCLUSION CRITERIA:

Patients with hepatic-dominant metastases where the life limiting component of the disease
is hepatic metastasis

Patients must have unresectable hepatic lesions or must be deemed unable or unadvisable to
undergo surgical resection

Have 5 or fewer lesions and with no single lesion greater than 10 cm in maximum diameter

Patients with extrahepatic metastases or an unresected primary lesion will be considered
eligible if the extrahepatic disease is minimal and stable

Serum Creatinine less than 2.0 mg/dl unless the measured creatinine clearance is greater
than 60 ml/min.

Absolute neutrophil count (ANC) greater than or equal to1500/m3 without help of
Filgastrim, hemoglobin greater than 8 g/dL, and platelet count greater than or equal to
75,000 m3

Bilirubin less than 3 mg/dl, and AST and ALT less than 5 X upper limit of normal except in
the presence of obstructive liver metastases where ALT/AST may be up to 10 X the upper
limit of normal.

Prothrombin Time (PT) within 2 seconds of the upper limit normal (INR less than 1.8)

Extent of hepatic metastases is approximately less than 60% of total hepatic volume

Patients must have pathology proof of neoplasm

Patients referred for ablation or radiation of liver neoplasm

ECOG performance status less than or equal to 2

Life expectancy greater than 3 months

At least 18 years of age

Age less than 85 years

Patients must have had no chemotherapy, radiotherapy, or biologic therapy for their
malignancy for at least 28 days prior to treatment and must have recovered from all
clinically significant side effects of therapeutic and diagnostic interventions.

EXCLUSION CRITERIA:

Portal Vein Occlusion or other contraindications to thermal ablation or radiation Prior
selective internal radiation therapy (SIRT) with Yttrium-90 or prior radiation to the
liver

Prior biliary diversion surgery

Patients requiring ongoing chronic anticoagulation will not be eligible.

Standard clinical screening procedures will be performed, and when it is clinically
low-risk to do so, patients will be taken off of aspirin or NSAIDS for a week prior to
RFA, as per clinical standard.

Patients with active bacterial infections with systemic manifestations (malaise, fever,
leucocytosis) are not eligible until completion of appropriate therapy.

Any exclusion criteria for radiation or for ablation, such as ataxia telengiectasia,
active connective tissue disease, or inflammatory bowel disease, or other known conditions
which predispose to radiation toxicities

Patients with an acute, critical illness

Pregnant or nursing mothers will not be eligible