Indication: Hepatocellular carcinoma (HCC) is the third most deadly cancer in the world. It is primarily seen in areas where hepatitis is endemic, such as Asia, but other risk factors include alcoholic cirrhosis.
Surgical resection and/or transplantation remain the only curative options. However, more than 80% of patients present with unresectable disease. For these patients with unresectable tumors, a variety of treatment options are available, including transarterial chemoembolization (TACE), radiofrequency ablation (RFA), radioactive microspheres, microwave coagulation, laser-induced thermotherapy, and percutaneous alcohol injection, all of which have similar survival rates. Stereotactic body radiotherapy (SBRT) for unresectable HCC is a relatively new treatment option made available because of significant improvements in diagnostic imaging and radiation delivery techniques. Although follow-up is limited, results show encouraging local control rates.
The investigators propose to conduct a Phase II study assessing the efficacy and safety of CyberKnife SBRT for the treatment of HCC.
Summary of Subject Eligibility Criteria:
Inclusion Criteria
1. Confirmed hepatocellular carcinoma according to one of three EASL criteria:
* Histopathology
* Two radiographic techniques (out of US, MRI, CT, Angiography) that confirm a lesion \>2 cm with arterial hypervascularization
* One radiographic technique that confirms a lesion \>2 cm with arterial hypervascularization and an AFP\>400 ng/mL
2. Unifocal liver tumors not to exceed 5 cm in greatest axial dimension. Multifocal lesions will be restricted to a maximum of 3 lesions with a maximum lesion size of 3 cm for each lesion, that can be treated within a single target volume within the same liver segment as long as the dose constraints to normal tissue can be met.
3. Volumn of uninvolved liver \>750 cc
4. Hepatic lesion in patients for whom surgical resection is not possible or patients who refuse surgery.
5. Eastern Clinical Oncology Group (ECOG) performance status 0, 1 or 2 (Appendix I)
6. Patients with liver disease classified as Child Pugh class A
7. Life expectancy \>6 months
8. Age \> 18 years old
9. Albumin \> 2.5 g/dL
10. Total Bilirubin \< 3 mg/dL
11. INR \<1.5
12. Transaminases (SGOT and SGPT) no more than 3 times the upper limit of normal
13. Creatinine \< 2.0 mg/dL
14. Both men and women and members of all races and ethnic groups are eligible for this study
15. Ability of the research subject or authorized legal representative to understand and the willingness to sign a written informed consent document Exclusion Criteria
1\. Prior surgery, chemotherapy or radiation for the liver tumor 2. Prior radiotherapy to the upper abdomen 3. Prior RFA or liver transplant 4. Tumors greater than 5 cm in greatest axial dimension 5. Child B status 6. Contraindication to receiving radiotherapy 7. Active gastrointestinal bleed within 2 weeks of study enrollment 8. Clinically significant ascites refractory to medical therapy 9. Women who are pregnant 10. Administration of any systemic chemotherapy within the last 6 months 11. Presence of multifocal lesions located in different lobes of the liver or extrahepatic metastases 12. Portal vein thrombus 13. Participation in another concurrent treatment protocol Intervention and Mode of Delivery: CyberKnife SBRT - External photon radiation. Procedure is outpatient. Synchrony Respiratory Tracking System Duration of Intervention and Evaluation: The duration of treatment will be 1 week.. The follow-up period will be for 3 years following completion of therapy.
