Safety, Efficacy, and Dosing of Stereotactic Radiosurgery for Hepato-cellular Carc/Colo-rectal Liver Metastases

Inclusion Criteria

• •2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• •3. Patients are not candidates for definitive surgical resection because of tumor location, hepatic function, or other medical or personal reasons.
• •4. Patients with HCC who are being considered for liver transplant may be entered as a bridge to transplant if it is considered by the transplant team that an ablative therapy would be of value while awaiting transplant.
• •5. If cirrhosis is present, patients will have Child-Pugh score of A or B (see Appendix A in the Master Protocol).
• •6. Patients will have tumors not optimally treated with radio-frequency ablation by interventional radiology, or by GI/transplant surgery. This could be for reasons of size, tumor location, or other reasons.
• •7. Ability to place fiducial markers in the vicinity of the tumor to allow for radiographic tracking of respiratory motion and tumor localization. Fiducial placement will generally be done by interventional radiology.
• •8. Estimates of hepatic tolerance must meet the criteria as defined in Section III. This eligibility will not be able to made definitively until the patient has agreed to participate. in the study and the appropriate scan analyses and dosimetry have been performed. No more than one decrement in dose from the planned dose level will be allowed for an individual patient because of exceeding the maximal liver doses before the patient is declared ineligible for study.
• •9. Adequate bone marrow and renal function as assessed by the following:
• •* Absolute neutrophil count (ANC) \> 1000/mm3
• •* Platelet count \> 80,000/mm3
• •* Creatinine \< 2.0 mg/dL OR Creatinine clearance \> 45 mL/min based on Cockcroft-Gault formula).
• •11. Patient is able to understand fully the potential risks and benefits of this approach and signs an appropriate informed consent.
• •12. Male and female of \>18 years of age. Male or female patients capable of reproduction must agree to use medically acceptable methods of contraception, such as an intrauterine device, diaphragm, with spermicide, condom with spermicide or abstinence. Inclusion of females of childbearing potential requires a negative pregnancy test within 14 days prior to study initiation.