Transarterial Chemoembolization vs CyberKnife for Recurrent Hepatocellular Carcinoma

NCT ID: NCT01327521

Last Updated: 2012-06-11

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28

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.

Conditions

Carcinoma, Hepatocellular

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

CyberKnife

Standard of Care

Intervention Type: DEVICE

TACE

Standard of Care

Intervention Type: PROCEDURE

CT Contrast

Standard of Care

Intervention Type: DRUG

doxorubicin

Standard of Care

Intervention Type: DRUG

Epirubicin

Standard of Care

Intervention Type: DRUG

5-fluorouracil

Standard of Care

Intervention Type: DRUG

Mitomycin C

Standard of Care

Intervention Type: DRUG

Gemcitabine

Standard of Care

Intervention Type: DRUG

Cisplatin

Standard of Care

Intervention Type: DRUG

SMANCS

Standard of Care

Intervention Type: DEVICE

Other Intervention Names

CK; Transcatheter arterial chemoembolization; contrast dye; Adriamycin; hydroxydaunorubicin; Ellence; Pharmorubicin; Epirubicin Ebewe; 5-FU; f5U; Adrucil; Carac; Efudix; Efudex; Fluoroplex; Mutamycin; MTC; Gemzar; cisplatinum; cis-diamminedichloroplatinum(II); CDDP; Platinol; Platinol-AQ; styrene maleic acid neocarzinostatin; poppyseed oil

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Accuray Incorporated

INDUSTRY

Sponsor Role: collaborator

Albert Koong

OTHER

Sponsor Role: lead

Responsible Party

Albert Koong

Associate Professor of Radiation Oncology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Albert Koong

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

Other Identifiers

ACCH001.0

Identifier Type: OTHER

Identifier Source: secondary_id

SU-05052010-5862

Identifier Type: OTHER

Identifier Source: secondary_id

HEP0030

Identifier Type: -

Identifier Source: org_study_id