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Transarterial Chemoembolization vs CyberKnife for Recurrent Hepatocellular Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01327521
Recruitment Status : Withdrawn (Accrual below target levels)
First Posted : April 1, 2011
Last Update Posted : June 11, 2012
Accuray Incorporated
Information provided by (Responsible Party):
Albert Koong, Stanford University

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Carcinoma, Hepatocellular Device: CyberKnife Procedure: TACE Drug: CT Contrast Drug: doxorubicin Drug: Epirubicin Drug: 5-fluorouracil Drug: Mitomycin C Drug: Gemcitabine Drug: Cisplatin Device: SMANCS Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: International Randomized Study of Transarterial Chemoembolization Versus CyberKnife for Recurrent Hepatocellular Carcinoma
Study Start Date : February 2011
Estimated Primary Completion Date : February 2014

Intervention Details:
  • Device: CyberKnife
    Standard of Care
    Other Name: CK
  • Procedure: TACE
    Standard of Care
    Other Name: Transcatheter arterial chemoembolization
  • Drug: CT Contrast
    Standard of Care
    Other Name: contrast dye
  • Drug: doxorubicin
    Standard of Care
    Other Names:
    • Adriamycin
    • hydroxydaunorubicin
  • Drug: Epirubicin
    Standard of Care
    Other Names:
    • Ellence
    • Pharmorubicin
    • Epirubicin Ebewe
  • Drug: 5-fluorouracil
    Standard of Care
    Other Names:
    • 5-FU
    • f5U
    • Adrucil
    • Carac
    • Efudix
    • Efudex
    • Fluoroplex
  • Drug: Mitomycin C
    Standard of Care
    Other Names:
    • Mutamycin
    • MTC
  • Drug: Gemcitabine
    Standard of Care
    Other Name: Gemzar
  • Drug: Cisplatin
    Standard of Care
    Other Names:
    • cisplatinum
    • cis-diamminedichloroplatinum(II)
    • CDDP
    • Platinol
    • Platinol-AQ
  • Device: SMANCS
    Standard of Care
    Other Names:
    • styrene maleic acid neocarzinostatin
    • poppyseed oil

Primary Outcome Measures :
  1. Freedom from local progression at 6 months and 12 months [ Time Frame: 6 months and 12 months ]

Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: at 6, 12 and 18 months ]
  2. Overall survival [ Time Frame: at 6, 12, 18 months and up to 3 years ]
  3. Serum AFP levels [ Time Frame: 1 month, 3 months, 6 months, 12 months and 18 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01327521

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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Albert Koong
Accuray Incorporated
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Principal Investigator: Albert Koong Stanford University

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Responsible Party: Albert Koong, Associate Professor of Radiation Oncology, Stanford University Identifier: NCT01327521    
Other Study ID Numbers: HEP0030
ACCH001.0 ( Other Identifier: Accuray Inc. )
SU-05052010-5862 ( Other Identifier: Stanford University )
First Posted: April 1, 2011    Key Record Dates
Last Update Posted: June 11, 2012
Last Verified: June 2012
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors