NCT01327521WithdrawnPhase 3
International Randomized Study of Transarterial Chemoembolization Versus CyberKnife for Recurrent Hepatocellular Carcinoma
Albert Koong1 site in 1 countryStarted: February 1, 2011Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Withdrawn
- Sponsor
- Locations
- 1
- Primary Endpoint
- Freedom from local progression at 6 months and 12 months
Study Overview
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:
- To determine the progression-free survival of TACE vs. CyberKnife SBRT
- To determine the overall survival of TACE vs. CyberKnife SBRT for locally recurrent HCC
- To determine the toxicities associated with TACE or CyberKnife SBRT for the treatment of recurrent HCC.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Outcomes
Primary Outcomes
Freedom from local progression at 6 months and 12 months
Time Frame: 6 months and 12 months
Secondary Outcomes
- Progression-free survival(at 6, 12 and 18 months)
- Overall survival(at 6, 12, 18 months and up to 3 years)
- Serum AFP levels(1 month, 3 months, 6 months, 12 months and 18 months)
Investigators
Albert Koong
Associate Professor of Radiation Oncology
Stanford University
Study Sites (1)
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