Transarterial Chemoembolization (TACE) vs. CyberKnife for Recurrent Hepatocellular Carcinoma (HCC)
|Recurrent Hepatocellular Carcinoma||Procedure: Transarterial Chemoembolization Radiation: CyberKnife SBRT||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||International Randomized Study of Transarterial Chemoembolization Versus CyberKnife® for Recurrent Hepatocellular Carcinoma|
- Freedom from local progression [ Time Frame: 12 months ]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.
- Progression-free survival [ Time Frame: 6, 12 and 18 months ]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.
- Overall survival [ Time Frame: Up to three years following therapy ]Overall survival will be determined as a measure of time from diagnosis of initial recurrence until death from any cause.
- Serum AFP levels [ Time Frame: 3, 6, 12 and 18 months ]
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).
- Freedom from local progression [ Time Frame: 6 and 18 months ]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.
|Study Start Date:||February 2011|
|Estimated Study Completion Date:||February 2016|
|Estimated Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
|Active Comparator: Transarterial Chemoembolization||
Procedure: Transarterial Chemoembolization
Transarterial Chemoembolization will be given within 12 weeks and up to 3 staged procedures, depending on the architecture of the tumor vasculature.
|Active Comparator: CyberKnife SBRT||
Radiation: CyberKnife SBRT
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01318200
|United States, California|
|Stanford Comprehensive Cancer Center|
|Stanford, California, United States, 94305|
|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|