Feasibility of Hypofractionated Stereotactic Radiotherapy in Patients With Hepatocellular Carcinoma

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed advanced hepatocellular carcinoma (HCC)

- Measurable disease, defined as ≥ 1 unidimensionally target lesion that can be
accurately measured by CT scan or MRI according to RECIST and must have a maximum
diameter ≤ 8 cm

- No known CNS tumors, including metastatic brain disease

- Child-Pugh class A-B cirrhotic status

PATIENT CHARACTERISTICS:

- Karnofsky performance status 60-100%

- Life expectancy ≥ 12 weeks

- WBC ≥ 2,000/μL

- Platelet count ≥ 60,000/mm³

- Hemoglobin ≥ 8.5 g/dL

- INR ≤ 2.3

- No malignancy within the past 3 years that is distinct in its primary site or
histology from HCC, except for carcinoma in situ of the cervix, treated basal cell
carcinoma, or superficial bladder tumors (i.e., Ta, Tis, and T1), or any other cancer
that has been curatively treated > 3 years prior to study entry

- No renal failure requiring hemodialysis or peritoneal dialysis

- No uncontrolled intercurrent illness including, but not limited to, any of the
following:

- Ongoing or active infection > grade 2

- NYHA class II-IV congestive heart failure

- Active coronary artery disease

- Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers
or digoxin

- Uncontrolled hypertension

- Condition that could jeopardize the safety of the patient or study compliance

- More than 6 months since prior myocardial infarction

- No history of variceal bleeding where the varices have not been eradicated or
decompressed by shunt placement

- No condition that would prevent the patient from undergoing marker implantation

- Not pregnant or nursing

- Negative pregnancy test

- No substance abuse, medical, psychological, or social condition that may interfere
with the patient's participation in the study or evaluation of the study results

PRIOR CONCURRENT THERAPY:

- Prior systemic chemotherapy allowed

- At least 6 weeks since prior non-radiation local therapy (e.g., surgery, hepatic
arterial therapy, chemoembolization, radiofrequency ablation, percutaneous ethanol
injection, or cryoablation)

- No prior radiotherapy to the liver

- Concurrent therapeutic anticoagulation (e.g., warfarin or heparin) allowed provided
that no prior evidence of underlying abnormality in PT, PTT, INR exists