Transarterial Chemoembolization (TACE) vs. CyberKnife for Recurrent Hepatocellular Carcinoma (HCC)
International Randomized Study of Transarterial Chemoembolization Versus CyberKnife® for Recurrent Hepatocellular Carcinoma
1 other identifier
interventional
N/A
1 country
1
Brief Summary
To compare the efficacy of Transarterial Chemoembolization (TACE) to CyberKnife stereotactic body radiotherapy in the treatment of patients with locally recurrent hepatocellular carcinoma (HCC) after TACE.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Feb 2011
Longer than P75 for phase_3
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 16, 2011
CompletedFirst Posted
Study publicly available on registry
March 18, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedFebruary 20, 2012
February 1, 2012
3 years
March 16, 2011
February 16, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Freedom from local progression
Freedom from local progression at time T is defined as lack of local progression in the treated liver lesion in the set of patients alive and on study at time T and without distant progression up to time T.
12 months
Secondary Outcomes (4)
Progression-free survival
6, 12 and 18 months
Overall survival
Up to three years following therapy
Serum AFP levels
3, 6, 12 and 18 months
Freedom from local progression
6 and 18 months
Study Arms (2)
Transarterial Chemoembolization
ACTIVE COMPARATORCyberKnife SBRT
ACTIVE COMPARATORInterventions
Transarterial Chemoembolization will be given within 12 weeks and up to 3 staged procedures, depending on the architecture of the tumor vasculature.
Dose is 45 Gy (15 Gy in 3 fractions) or 36 Gy(12 Gy in 3 fractions). Tumors should receive the higher dose unless normal tissue constraints cannot be met.
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 contrast liver CT
- A recent serum AFP must 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 7.5 cm as long as the dose constraints to normal tissue can be met.
- Eastern Clinical Oncology Group performance status 0, 1 or 2 (Appendix I).
- Patients with liver disease classified as Child Pugh class A/B, if Child's class B, score must be 8 or less.
- Life expectancy \>= 6 months
- Age \>= 18 years old
- Albumin \>= 2.5 g/dL
- Total Bilirubin \<= 3 mg/dL
- +4 more criteria
You may not qualify if:
- Prior radiation for the recurrent liver tumor
- Prior radiotherapy to the upper abdomen
- Prior RFA to index lesion
- Liver transplant
- Tumors greater than 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 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
- Accuray Incorporatedlead
- Stanford Universitycollaborator
Study Sites (1)
Stanford Comprehensive Cancer Center
Stanford, California, 94305, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Albert Koong, MD, PhD
Stanford Comprehensive Cancer Center
- STUDY CHAIR
Daniel Chang, MD
Stanford Comprehensive Cancer Center
- STUDY CHAIR
Nishita Kothary, MD
Stanford Comprehensive Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2011
First Posted
March 18, 2011
Study Start
February 1, 2011
Primary Completion
February 1, 2014
Study Completion
February 1, 2016
Last Updated
February 20, 2012
Record last verified: 2012-02