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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
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.
Stanford Comprehensive Cancer Center
Stanford, California, United States
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.
Time frame: 12 months
Progression-free survival
Progression-free survival will be defined as subject alive and free from local progression, disease recurrence elsewhere in the liver, extrahepatic progression, or clinical deterioration unattributable to another underlying medical condition in the absence of clear radiographic findings of progressive disease.
Time frame: 6, 12 and 18 months
Overall survival
Overall survival will be determined as a measure of time from diagnosis of initial recurrence until death from any cause.
Time frame: Up to three years following therapy
Serum AFP levels
Serum AFP levels will be measured at specific points during the study. The 2 endpoints to be analyzed are: * Initial AFP levels * AFP response - the percent decrease in serum AFP levels from the initial result to the eventual nadir after therapy These endpoints will be correlated to the clinical endpoints (freedom from local progression, progression free-survival, and overall survival).
Time frame: 3, 6, 12 and 18 months
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.
Time frame: 6 and 18 months
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