A Phase II Study for the Treatment of Unresectable or Medically Inoperable Hepatocellular Carcinoma Using Stereotactic Body Radiotherapy (SBRT) in British Columbia
Radiotherapy is not considered standard of care practice for patients for inoperable
hepatocellular carcinoma despite the tumour's inherent radiosensitivity. The major challenge
has been improving radiation delivery without exceeding dose limits of the surrounding
normal liver. Recent technological advances with tumour localization and targeting, imaging,
treatment planning and delivery have allowed for safe delivery of radiation with tumorcidal
effect and minimal treatment-related toxicity.
This study has three specific aims:
1. To develop, validate, and quality test HDR Stereotactic Body Radiotherapy (SBRT) Gated
RapidArc technique for application in human liver tumours. And furthermore, to test whether
HDR SBRT Gated RapidArc can be efficiently and safely delivered to a very large patient
population previously ineligible for any therapy (HCC patients with tumours >5cm).
3. To determine if 11C-choline/18F-FDG CT-PET or perfusion CT imaging (that characterize
changes in tumour proliferation, glycolysis, and vasculature, respectively) can provide
practical non-invasive biomarkers of tumour response, local tumour control, or normal tissue
toxicity.
4. To determine if immunologic studies of pre- and post-treatment blood samples can provide
biomarkers of tumour response, local and systemic tumour control, or triggers for normal
tissue toxicity.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research
One year local progression-free rate
Approximately 1 year
Yes
Mohamed Khan, MD
Principal Investigator
British Columbia Cancer Agency
Canada: Health Canada
H13-00481
NCT01850316
July 2013
August 2020
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