Stereotactic Body Radiation Therapy (SBRT) Versus Trans-Arterial Chemoembolization (TACE) as Bridge to Liver Transplant

For patients with hepatocellular carcinoma (HCC) who are waiting for a liver transplant,
local treatment of their disease has become the standard of care in an effort to decrease
dropout rates and as a means of reducing tumor recurrence after transplantation. However, the
best modality for patients undergoing treatment as a bridge to transplantation is unclear.
This study will compare stereotactic body radiation therapy (SBRT) to trans-arterial
chemoembolization (TACE) as a bridging strategy for patients with HCC undergoing orthotopic
liver transplantation. We propose that SBRT will be associated with longer time intervals
between initial treatment and the need for retreatment, compared to TACE, as a "bridge" to
orthotopic liver transplantation.

Inclusion Criteria

- Patients with hepatocellular carcinoma are eligible for this trial.

Hepatocellular carcinoma is defined as having at least one of the following:

Biopsy proven hepatocellular carcinoma (HCC); or A discrete hepatic tumor(s) as defined by
the Barcelona (29) criteria for cirrhotic patients, >2cm with arterial hypervascularity and
venous or delayed phase washout on CT or MRI.

- Patient is within Milan Criteria and "listed" for orthotopic liver transplantation.

- Patients must have a Zubrod performance status of ≤2.

- Patients must have a life expectancy of at least 12 weeks.

- Patients must be 18 years of age or older. Adult patients of all ages, both sexes and
all races will be included in this study.

- Patients must be Child-Turcotte-Pugh (CTP) Class A or Class B (≤ 7).

- Female patients within reproductive years may not be, nor become, pregnant during
participation in this study. Both male and female patients within reproductive years
must agree to use an effective contraceptive method during treatment. Women of
childbearing age will be required to undergo a urine or serum pregnancy test to ensure
they are not pregnant.

- Patients must have adequate organ function within 2 weeks of enrollment. Bone marrow:
Platelets ≥30,000/mm3 Renal: BUN ≤40 mg/dl; creatinine ≤2.0 mg/dl Hepatic: INR ≤ 1.5
or correctable by Vitamin K, unless anti- coagulated for another medical reason
Bilirubin < 3 mg/dl (in the absence of obstruction or pre-existing disease of the
biliary tract, e.g. primary sclerosing cholangitis) Patients uninvolved liver volume
will be estimated and must be > 700ml.

- Patients must sign an informed consent form approved for this purpose by the
Institutional Review Board (IRB) of the Lahey Hospital and Medical Center indicating
that they are aware of the investigational aspects of the treatment and the potential
risks.

Exclusion Criteria

- Patients in a "special category" designated the Public Health Service, including
patients younger than 18, pregnant women, and prisoners.

- Refractory ascites or ascites that requires paracentesis for management.

- Patients with a solitary lesion greater than 5.0cm in size or more than 2 discrete
lesions the largest greater than 3.0 cm in size.

- Known allergy to intravenous iodinated contrast agents unresponsive to prednisone
pre-treatment.