Randomized Trial Comparing Stereotactic Body Radiation Therapy to Microwave Ablation for the Treatment of Localized Hepatocellular Carcinoma

Inclusion Criteria:

- Patients with hepatocellular carcinoma (HCC) are eligible for this trial. HCC is
defined as having at least one of the following:

1. HCC diagnosed either on biopsy or based on standard imaging criteria on contrast
enhanced CT or MRI (arterial enhancement with washout and pseudocapsule); or

2. A discrete hepatic tumor(s) as defined by the Barcelona criteria10 for cirrhotic
patients, >1 cm with arterial hypervascularity and venous or delayed phase
washout on CT or MRI

3. Presentation at multidisciplinary liver tumor board to assess eligibility for
either SBRT or MWA

- Patients must have 1-2 intrahepatic foci of HCC and may not be candidates for refuse
hepatic resection. Patients who are on the organ wait list for (orthotopic liver
transplantation) OLT will be considered for this trial as a "bridge" to transplant.

- Patients with 1 focus of HCC will be eligible if their tumor is 3.5 cm or less in
greatest diameter. Patients with 2 foci of HCC will be eligible if each lesion is 3.5
cm in diameter or less and the combined diameter of both lesions is 5 cm or less.

- The foci of HCC must be in an anatomic location amendable to treatment by both MWA and
SBRT.

- The patient must have an ECOG performance status of ≤ 2 (Eastern Cooperative Oncology
Group Performance Status is an attempt to quantify cancer patients' general well-being
and activities of daily life. The score ranges from 0 to 5 where 0 is asymptomatic and
5 is death).

- Patients must have recovered from the acute effects of prior liver-directed therapy
(e.g., RT, RFA, MWA or TACE) and a minimum of 4 weeks must have passed since the last
procedure and protocol therapy.

- Patients must have:

1. Platelets ≥ 50,000/mm3

2. Child Pugh class A liver function or class B7 (Appendix II)

3. INR (international normalized ratio (for anticoagulant monitoring)) < 1.5

- The patient must have a life expectancy of at least 12 weeks

- The patient must be at least 18 years old

- Patients must sign an IRB approved informed consent form for this purpose indicating
that they are aware of the investigational aspects of the treatment and the potential
risks. They also must be able to understand and the willing to sign a written informed
consent.

Exclusion Criteria:

- Patients who have received prior abdominal radiation

- Patients with 3 or more foci of HCC

- Patients whose HCC involves the local vasculature, regional lymph nodes or distant
metastatic sites

- Patients with Child Pugh liver function worse than B7