A Phase I/II Trial Of the Feasibility of Treatment of Cancer Involving the Liver With High Dose Radiation Delivered by 3D Conformal Radiation Therapy and Radiosurgery

Inclusion Criteria:

- Patients must have new hepatic lesions suggestive of metastasis, or otherwise biopsy
proven disease if there is no previously negative scan.

- Patients with chemotherapy responsive or resistant disease are acceptable. Primary
hepatobiliary tumors are also acceptable. In each case, the patient must be deemed
unresectable by a hepatic surgeon.

- Patients with multiple hepatic lesions may be included if they meet the volumetric
criteria for dose specification. Likewise, patients with metastases to organs other
than the liver, or patients with residual primary disease may be included if it is
judged that longevity will be determined by the hepatic disease.

- KPS ≥70

- Age ≥ 18 years

- Bilirubin <2.0 mg/dl, AST < 2.5 x normal, ALT < 2.5 x normal, Platelets > 80,000/mm3

- Chemotherapy treatment before or after radiation will be allowed

- Informed consent must be obtained., Patient must be judged unresectable by a hepatic
surgeon, or must have refused surgery

- Patient must be able to tolerate radiation treatment as judged by the Principal
Investigator or co-PI.

- Previous Liver resection is allowed

- Active disease outside the liver is allowed.

- Liver lesion should be visible on CT or MRI.

Exclusion Criteria:

- No active hepatitis or radiographic evidence of diffuse macro-nodular cirrhosis.
Patients with lesser degrees of cirrhosis, not associated with portal hypertension or
hepatic failure, are eligible but radiation schedule and total dose will be
appropriately modified.

- Women who are pregnant