Transarterial Chemoembolization (TACE) vs. CyberKnife for Recurrent Hepatocellular Carcinoma (HCC)

Not Recruiting

Trial ID: NCT01318200


To compare the efficacy of Transarterial Chemoembolization (TACE) to CyberKnife stereotactic body radiotherapy in the treatment of patients with locally recurrent hepatocellular carcinoma (HCC) after TACE.

Official Title

International Randomized Study of Transarterial Chemoembolization Versus CyberKnife® for Recurrent Hepatocellular Carcinoma

Stanford Investigator(s)

Nishita Kothary, MD
Nishita Kothary, MD

Professor of Radiology (Interventional Radiology)


Inclusion Criteria:

   - Confirmed hepatocellular carcinoma by one of the following:

      1. Histopathology

      2. One radiographic technique that confirms a lesion >2 cm with arterial enhancement
      with washout on delayed phase.

   - Hepatic lesion in patients for whom surgical resection is not possible or would not
   result in an opportunity for cure.

   - Radiographic evidence of persistent, progressive or recurrent disease in an area
   previously treated with TACE. This evaluation should be determined after 6 weeks of
   initial TACE.

   - Multi-specialty evaluation whereby the recurrent liver lesion was deemed by both the
   attending radiation oncologist and interventional radiologist amenable to treatment by
   the respective modality

      1. Eligible patients must undergo an IV contrast CT scan of the liver within 6 weeks
      of enrollment onto the study; a contrast enhanced liver MRI may be substituted
      for the contrast liver CT

      2. A recent serum AFP must be obtained within 4 weeks of enrollment.

   - Unifocal liver tumors not to exceed 7.5 cm in greatest axial dimension. Multifocal
   lesions will be restricted to lesions that can be treated within a single target
   volume within the same liver segment and to an aggregate of 7.5 cm as long as the dose
   constraints to normal tissue can be met.

   - Eastern Clinical Oncology Group performance status 0, 1 or 2 (Appendix I).

   - Patients with liver disease classified as Child Pugh class A/B, if Child's class B,
   score must be 8 or less.

   - Life expectancy >= 6 months

   - Age >= 18 years old

   - Albumin >= 2.5 g/dL

   - Total Bilirubin <= 3 mg/dL

   - INR <= 1.5

   - Creatinine <= 2.0 mg/dL

   - Both men and women and members of all races and ethnic groups are eligible for this

   - Ability of the research subject or authorized legal representative to understand and
   the willingness to sign a written informed consent document.

Exclusion Criteria:

   - Prior radiation for the recurrent liver tumor

   - Prior radiotherapy to the upper abdomen

   - Prior RFA to index lesion

   - Liver transplant

   - Tumors greater than 7.5 cm in greatest axial dimension

   - Portal vein thrombus

   - Large varices within 2 cm of index lesion (seen on cross section imaging)

   - Contraindication to receiving radiotherapy

   - Active gastrointestinal bleed within 2 weeks of study enrollment

   - Ascites refractory to medical therapy

   - Women who are pregnant

   - Administration of chemotherapy within the last 1 month

   - Presence of multifocal lesions located in different lobes of the liver or extrahepatic

   - Participation in another concurrent systemic treatment protocol

   - Prior history of malignancy other than HCC


procedure: Transarterial Chemoembolization

radiation: CyberKnife SBRT

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305