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. |
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Condition | Carcinoma, Hepatocellular |
Intervention | Device: CyberKnife Procedure: TACE Drug: CT Contrast Drug: doxorubicin Drug: Epirubicin Drug: 5-fluorouracil Drug: Mitomycin C Drug: Gemcitabine Drug: Cisplatin Device: SMANCS |
Phase | Phase 3 |
Sponsor | Albert Koong |
Responsible Party | Stanford University |
ClinicalTrials.gov Identifier | NCT01327521 |
First Received | March 30, 2011 |
Last Updated | June 7, 2012 |
Last verified | June 2012 |
Tracking Information[ + expand ][ + ]
First Received Date | March 30, 2011 |
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Last Updated Date | June 7, 2012 |
Start Date | February 2011 |
Estimated Primary Completion Date | Not Provided |
Current Primary Outcome Measures | Freedom 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 |
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Descriptive Information[ + expand ][ + ]
Brief Title | Transarterial Chemoembolization vs CyberKnife for Recurrent Hepatocellular Carcinoma |
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Official Title | International 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 Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Carcinoma, Hepatocellular |
Intervention | Device: 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:
Standard of Care Other Names:
Standard of Care Other Names:
Standard of Care Other Names:
Standard of Care Other Names: GemzarDrug: Cisplatin Standard of Care Other Names:
Standard of Care Other Names:
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Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
Recruitment Status | Withdrawn |
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Estimated Enrollment | Not Provided |
Estimated Completion Date | Not Provided |
Estimated Primary Completion Date | February 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 |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01327521 |
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Other Study ID Numbers | HEP0030 |
Has Data Monitoring Committee | Yes |
Information Provided By | Stanford University |
Study Sponsor | Albert Koong |
Collaborators | Accuray Incorporated |
Investigators | Principal Investigator: Albert Koong Stanford University |
Verification Date | June 2012 |
Locations[ + expand ][ + ]
Stanford University School of Medicine | Stanford, California, United States, 94305 |
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