Hepatocellular Carcinoma Using Stereotactic Body Radiotherapy (NCT01850316) | Clinical Trial Compass
UnknownNot Applicable
Hepatocellular Carcinoma Using Stereotactic Body Radiotherapy
Canada13 participantsStarted 2013-07
Plain-language summary
Respiratory-gated, volumetric-modulated arc therapy will be used for the clinical development of high dose rate Stereotactic Body Radiotherapy (SBRT) in inoperable hepatocellular carcinoma (HCC). These treatments should enhance local control, progression-free survival and potentially overall survival in HCC patients. The investigators will also examine the mechanism of tumour and microenvironmental response to high dose radiation, and search for potential biomarkers to optimize and individualize therapy. Pre-treatment and follow-up PET/CT imaging with 11C-choline, 18F-fluorodeoxyglucose (FDG) and CT perfusion will examine in-vivo changes in proliferation, glycolysis, and the tumour vasculature, respectively, and blood samples will look for immunologic biomarkers of tumour response.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age \> 18 years old
✓. Multi-phase CT scan of the liver within 8 weeks of radiation planning demonstrating:
✓. FDG-PET scan within 12 weeks prior to radiation planning
✓. Patients must have HCC diagnosed by either: i) pathological confirmation, or ii) intrahepatic vascular enhancement of the lesion demonstrated by at least two imaging modalities, or iii) intrahepatic vascular enhancement of the lesion demonstrated by one imaging modality if AFP \> 200 in the setting of liver cirrhosis or chronic hepatitis B without cirrhosis (EASL consensus guidelines)
✓. Liver HCC must be deemed unresectable as determined by an experienced liver surgeon, or the patient must be medically inoperable or refuse surgery, and extra-hepatic metastases must not be present (Patients with potential resectable tumours who are deemed unresectable based on medical inoperability or simultaneous extra-hepatic metastases will be eligible to receive SBRT).
✓. Patients must be discussed in a multidisciplinary setting where opinions regarding radiofrequency ablation, various embolotherapies, and targeted biologics are considered, but not eligible for. Patients must have recovered from the effects of previous therapies before SBRT.
✓. Eastern Clinical Oncology Group performance status 0,1 or 2 or a Karnofsky performance status of ≥ 60
. Adequate organ function as assessed by the following blood work:
Exclusion criteria
✕4. Patient signs a study-specific informed consent form. If the patient's mental status precludes this, written informed consent may be given by the patient's legal representative. A translator will be provided if the patient has a language barrier.
✕5. Treatment plans meet acceptable dose constraints and Liver Veff is ≤ 0.55
✕. Patients with active hepatitis, encephalopathy, or ascites related to liver failure
✕. Female patients who are pregnant (verify with blood test if patient is pre-menopausal). Pre-menopausal patients may also not become pregnant during participation in this study.
✕. Prior external beam radiation to the upper abdomen
✕. Patients with distant metastases or extrahepatic nodal progression (patients with portal venous thrombosis and liver hilum nodal involvement remain eligible)