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

Participation Requirements

• Sex:

  ALL

• Eligible Ages:

  18 and up

Participation Criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* Severe cirrhosis or liver failure defined as Child Pugh \> B7
* Primary liver tumor or liver metastasis \> 25 cm in maximal dimension.
* Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
* Severe, active co-morbidity, defined as limiting the patients life to less than 6 months
* Active hepatitis or clinically significant liver failure.
* 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.