Phase II Trial of Stereotactic Body Radiation Therapy for Unresectable Hepatocellular Carcinoma
From July 2003 to May 2007, over 40 patients with hepatocellular carcinoma participated in
two studies at Princess Margaret Hospital (PMH) designed to determine the safety of treating
hepatocellular carcinoma with SBRT. These studies have shown that SBRT can be delivered
safely to the majority of patients with hepatocellular carcinoma. The treated tumour was
controlled (shrank or remained the same size) in 78% of patients at one year following
treatment.The median survival of patients was 11 months (i.e. half of patients survived
longer and half shorter than 11 months). This survival rate is better than that expected in
patients treated with supportive care only (no treatment other than care to make you feel
better). Supportive care patients have a median survival rate of 3-9 months. We expect that
the benefits of SBRT in this study will be similar to those observed in our initial studies.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine one year local progression free rate, defined as lack of progression within the irradiated volume, using RECIST criteria
5 years
No
Laura Dawson, MD
Principal Investigator
University Health Network, Princess Margaret Hospital
Canada: Ethics Review Committee
UHN REB 07-0346-C
NCT00914355
August 2007
August 2013
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