Combination SBRT With TACE for Unresectable Hepatocellular Carcinoma
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Combination Stereotactic Body Radiotherapy (SBRT) With Transarterial Chemo-Embolization (TACE) for Unresectable Hepatocellular Carcinoma|
- Freedom From Local Progression of TACE and SBRT at 12 Months [ Time Frame: 12 months ] [ Designated as safety issue: No ]Freedom from local progression is defined as the time from start of treatment until the first occurrence of local progression. Local progression is defined as progression in the treated lesion according to the RECIST criteria. Progression outside the treated lesion and/or death will be considered as competing risks. The data was analyzed in a competing risk model with death as a competing risk. The outcome reported is the cumulative incidence at 12 months.
- To Determine the Progression-free Survival of TACE and SBRT at 18 Months [ Time Frame: 18 months ] [ Designated as safety issue: No ]Progression free survival is defined as the time from the start of treatment until the first progression or death. Progression will be defined as either local progression, disease occurring elsewhere in the liver, extrahepatic progression or clinical deterioration attributable to another underlying medical condition in the absence of clear radiographic findings of progressive disease.
- To Determine the Overall Survival of TACE and SBRT at 18 Months [ Time Frame: 18 months ] [ Designated as safety issue: No ]Overall survival is defined as the time from the start of treatment until death from any cause.
- Median Progression Free Survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]Time to progression free survival is defined as the time from randomization until either death or progression of disease. The median survival was calculated using a Kaplan Meier algorithm.
|Study Start Date:||September 2009|
|Study Completion Date:||March 2014|
|Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Experimental: Stereotactic body radiotherapy (SBRT)
SBRT will be delivered on Varian's linear accelerator with On-Board Imaging (OBI) capabilities. The tumor will be tracked with the ethiodol material from the TACE procedure, and respiratory gating will be used to minimize motion due to respiration. Treatment will be given in either 3 or 5 fractions . SBRT will take place after the treatment planning and within 12 weeks of the last TACE procedure.
Doses: 45 Gy at 15 Gy/fraction , 36 Gy at 12 Gy/fraction, 45 Gy at 9 Gy/fraction, 40 Gy at 8 Gy/fraction
Standard of Care
Other Names:Procedure: SBRT
Standard of Care
Other Name: stereotactic body radiotherapy
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.
Outcome of this disease is poor, mostly due to the fact that >80% of patients present with unresectable disease. Surgery or transplantation remain the only curative options. For the vast majority of patients who are unresectable, a variety of treatment options are available, including transarterial chemo-embolization (TACE), radiofrequency ablation, 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 great 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 radiotherapy as a means of intensifying local therapy, with some evidence of benefit.
TACE remains the dominant mode of local therapy for unresectable HCC. However, recurrence rates are high. The recent randomized trial suggests that a combination of local therapy (TACE and radiofrequency ablation [RFA]) is superior to either therapy alone, providing proof of principle that combined local treatment is most likely more effective for HCC. Because SBRT is rapidly becoming an accepted local therapy for hepatic lesions, its role in treating HCC needs to be further defined. Studies combining TACE and external beam radiotherapy have shown encouraging results, so the logical next step is to combine TACE with SBRT, which delivers a radiobiologically more intensive dose of radiation. However, toxicity data are lacking, since this combination has not been previously reported.
We propose to conduct a trial of trans-arterial chemo-embolization (TACE) and SBRT for unresectable HCC.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01020812
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Daniel T Chang||Stanford University|