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

Phase 3
18 Years
Not Enrolling
Carcinoma, Hepatocellular

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Trial Information

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

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.

Exclusion Criteria:

- Prior radiation for the recurrent liver tumors

- Prior radiotherapy to the upper abdomen

- Prior RFA to index lesion

- Liver transplant

- Tumors >= 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 any systemic chemotherapy within the last 1 month

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

- Participation in another concurrent SYSTEMIC treatment protocol

- Prior history of malignancy other than HCC

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Freedom from local progression at 6 months and 12 months

Outcome Time Frame:

6 months and 12 months

Safety Issue:


Principal Investigator

Albert Koong

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University


United States: Institutional Review Board

Study ID:




Start Date:

February 2011

Completion Date:

Related Keywords:

  • Carcinoma, Hepatocellular
  • Carcinoma
  • Carcinoma, Hepatocellular



Stanford University School of MedicineStanford, California  94305-5317