Study Stopped
Accrual below target levels
Transarterial Chemoembolization vs CyberKnife for Recurrent Hepatocellular Carcinoma
International Randomized Study of Transarterial Chemoembolization Versus CyberKnife for Recurrent Hepatocellular Carcinoma
3 other identifiers
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 30, 2011
CompletedFirst Posted
Study publicly available on registry
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedJune 11, 2012
June 1, 2012
3 years
March 30, 2011
June 7, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Freedom from local progression at 6 months and 12 months
6 months and 12 months
Secondary Outcomes (3)
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
Interventions
Standard of Care
Standard of Care
Eligibility Criteria
You may qualify if:
- 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
- +3 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Albert Koonglead
- Accuray Incorporatedcollaborator
Study Sites (1)
Stanford University School of Medicine
Stanford, California, 94305, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Albert Koong
Stanford University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor of Radiation Oncology
Study Record Dates
First Submitted
March 30, 2011
First Posted
April 1, 2011
Study Start
February 1, 2011
Primary Completion
February 1, 2014
Last Updated
June 11, 2012
Record last verified: 2012-06