International Randomized Study of Transarterial Chemoembolization Versus CyberKnife® for Recurrent Hepatocellular Carcinoma
Hepatocellular carcinoma (HCC) is the third most deadly cancer in the world. It is
primarily seen in areas where hepatitis is endemic, such as Asia, but other risk factors
include alcoholic cirrhosis.
Surgical resection and/or transplantation remain the only curative options. However, more
than 80% of patients present with unresectable disease. For these patients with
unresectable tumors, a variety of treatment options are available, including transarterial
chemoembolization (TACE), radiofrequency ablation (RFA), radioactive microspheres, microwave
coagulation, laser-induced thermotherapy, and percutaneous alcohol injection, all of which
have similar survival rates. Stereotactic body radiotherapy (SBRT) for unresectable HCC is
a relatively new treatment option made available because of significant improvements in
diagnostic imaging and radiation delivery techniques. Although follow-up is limited,
results show encouraging local control rates. Some investigators have combined TACE with
fractionated conventional radiotherapy as a means of intensifying local therapy, with
evidence of efficacy.
TACE remains the dominant mode of local therapy for unresectable HCC. However, recurrence
rates are high. Because SBRT is rapidly becoming an accepted local therapy for hepatic
lesions, its role in treating HCC needs to be further defined. Moreover, once patients have
recurred after initial TACE, it is unclear if additional TACE will be as effective or if
another mode of local therapy such as SBRT would be preferable.
We propose to conduct a multicenter randomized study comparing TACE vs. SBRT using
CyberKnife for locally recurrent HCC. Locally recurrent HCC will include lesions that
persist, progress or recur minimum 3 months after initial TACE.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Albert Koong, MD, PhD
Stanford Comprehensive Cancer Center
United States: Institutional Review Board
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