Transarterial Chemoembolization vs CyberKnife for Recurrent Hepatocellular Carcinoma

Overview[ - collapse ][ - ]

Purpose 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.
ConditionCarcinoma, Hepatocellular
InterventionDevice: CyberKnife
Procedure: TACE
Drug: CT Contrast
Drug: doxorubicin
Drug: Epirubicin
Drug: 5-fluorouracil
Drug: Mitomycin C
Drug: Gemcitabine
Drug: Cisplatin
Device: SMANCS
PhasePhase 3
SponsorAlbert Koong
Responsible PartyStanford University
ClinicalTrials.gov IdentifierNCT01327521
First ReceivedMarch 30, 2011
Last UpdatedJune 7, 2012
Last verifiedJune 2012

Tracking Information[ + expand ][ + ]

First Received DateMarch 30, 2011
Last Updated DateJune 7, 2012
Start DateFebruary 2011
Estimated Primary Completion DateNot Provided
Current Primary Outcome MeasuresFreedom from local progression at 6 months and 12 months [Time Frame: 6 months and 12 months] [Designated as safety issue: No]
Current Secondary Outcome Measures
  • Progression-free survival [Time Frame: at 6, 12 and 18 months] [Designated as safety issue: No]
  • Overall survival [Time Frame: at 6, 12, 18 months and up to 3 years] [Designated as safety issue: No]
  • Serum AFP levels [Time Frame: 1 month, 3 months, 6 months, 12 months and 18 months] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief TitleTransarterial Chemoembolization vs CyberKnife for Recurrent Hepatocellular Carcinoma
Official TitleInternational Randomized Study of Transarterial Chemoembolization Versus CyberKnife for Recurrent Hepatocellular Carcinoma
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.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 3
Study DesignAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionCarcinoma, Hepatocellular
InterventionDevice: CyberKnife
Standard of Care
Other Names:
CKProcedure: TACE
Standard of Care
Other Names:
Transcatheter arterial chemoembolizationDrug: CT Contrast
Standard of Care
Other Names:
contrast dyeDrug: 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 Names:
GemzarDrug: 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
Study Arm (s)Not Provided

Recruitment Information[ + expand ][ + ]

Recruitment StatusWithdrawn
Estimated EnrollmentNot Provided
Estimated Completion DateNot Provided
Estimated Primary Completion DateFebruary 2014
Eligibility Criteria
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
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT01327521
Other Study ID NumbersHEP0030
Has Data Monitoring CommitteeYes
Information Provided ByStanford University
Study SponsorAlbert Koong
CollaboratorsAccuray Incorporated
Investigators Principal Investigator: Albert Koong Stanford University
Verification DateJune 2012

Locations[ + expand ][ + ]

Stanford University School of Medicine
Stanford, California, United States, 94305