Transarterial Chemoembolization (TACE) Versus TACE Plus Stereotactic Body Radiation Therapy (SBRT) in Liver Carcinoma

Prior treatment

• Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields

Other illness

• Severe cirrhosis or liver failure defined as Child Pugh \> B7
• Active hepatitis or clinically significant liver failure.

Other

• Primary liver tumor or liver metastasis \> 25 cm in maximal dimension.
• Severe, active co-morbidity, defined as limiting the patients life to less than 6 months
• Pregnancy, nursing women, or women of childbearing potential, and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be teratogenic.

• Primary hepatobiliary cancer confirmed pathologically
• Non - lymphoma liver metastases confirmed pathologically
• Radiographic liver lesions most consistent with metastases, in a patient with known pathologically proven non - lymphoma cancer and a previously negative CT or MRI of the liver
• Hepatocellular carcinoma diagnosed with vascular enhancement of the lesion consistent with hepatocellular carcinoma, and with an elevated AFP, in the setting of cirrhosis or chronic hepatitis.
• ≤ 5 liver lesions measurable on a contrast - enhanced liver CT or MRI performed within 90 days prior to study entry.
• Primary liver lesion or liver metastases measuring ≤ 25 cm.
• Extrahepatic cancer is permitted if liver involvement is judged to be life - limiting.
• All intrahepatic disease must be encompassed within the radiation fields according to protocol criteria.
• Patient must be judged medically or surgically unresectable
• Zubrod Performance Scale = 0 - 3
• Age \> 18
• All intrahepatic disease must be amenable to TACE
• Previous liver resection or ablative therapy is permitted.
• Chemotherapy must be completed at least 2 weeks prior to radiation therapy or TACE, and not planned to be administered for at least 1 week (for anthracyclines at least 4 weeks) after completion of treatment.
• Life expectancy \> 6 months.
• Women of childbearing potential and male participants must practice adequate contraception.
• Patient must sign study specific informed consent prior to study entry.
  • Pretreatment Evaluations Required for Eligibility:
• A complete history and general physical examination.
• CBC, INR, Total bilirubin, albumin, alkaline phosphatase, ALT, AST within 4 weeks prior to study entry. Appropriate levels are as follows:
• Absolute neutrophil count (ANC) ≥ 1,500 cells / mm3
• Platelets ≥ 70,000 cells / mm3
• Hemoglobin ≥ 8.0 g / dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g / dl is acceptable.)
• Total bilirubin \< 3 mg / dL
• Prothrombin time / INR \< 2 (if not on anticoagulants)
• Albumin ≥ 28 g / L
• AST and ALT \< 10 times ULN