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

Primary Objective: To compare the efficacy of TACE vs. CyberKnife SBRT in the treatment of locally recurrent HCC after initial TACE. Secondary Objectives: 1. To determine the progression-free survival of TACE vs. CyberKnife SBRT 2. To determine the overall survival of TACE vs. CyberKnife SBRT for locally recurrent HCC 3. To determine the toxicities associated with TACE or CyberKnife SBRT for the treatment of recurrent HCC.

Stanford is not currently accepting new patients for this trial. You may want to check to see if other locations are recruiting.



  • device : SMANCS
  • device : CyberKnife
  • drug : Epirubicin
  • drug : Mitomycin C
  • drug : Gemcitabine
  • drug : Cisplatin
  • drug : doxorubicin
  • drug : CT Contrast
  • drug : 5-fluorouracil
  • procedure : TACE

Phase: Phase 3


Ages Eligible For Study:

18 Years - N/A

Inclusion Criteria

- Confirmed hepatocellular carcinoma by one of the following: - Histopathology - 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 - 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 IV contrast CT of the liver. - A recent serum AFP must also 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 7.5cm as long as the dose constraints to normal tissue can be met - Eastern Clinical Oncology Group performance status 0, 1 or 2 - Patients with liver disease classified as Child Pugh class A/B; if Child's class B, score must be 8 or less - Albumin >= 2.5 g/dL - Total bilirubin <= 3 mg/dL - INR <= 1.5 - Creatinine <= 2.0 mg/dL - Age >= 18 years old - Life expectancy>= 6 months - Ability of the research subject or authorized legal representative to understand and the willingness to sign a written informed consent document.

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Contact information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Laurie Ann Columbo
Not Recruiting

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