Liver Tumors
Conditions
Keywords
Liver malignancy, Stereotactic Body Radiation Therapy, Efficacy of SBRT in liver tumors, Hepatic toxicity with SBRT
Brief summary
Patients with primary hepato-biliary malignancies or liver metastases from gastrointestinal cancer suffer substantial morbidity and mortality from their hepatic disease. Curative resection is feasible only for selected subgroups of patients. The majority of patients have unresectable and incurable disease. Aggressive arterial and systemic chemotherapy have been used in recent years with improved response and survival. However, a significant number of patients, at least one-third of patients with liver metastases from colorectal cancer and two-third or higher of unresectable hepatobiliary cancer, continue to die of liver failure from progressive disease in the liver. Percutaneous ethanol injections, chemoembolization, cryotherapy and thermal ablation using radiofrequency have been used to treat selected patients with smaller tumors (3-4 cm) in areas away from major blood vessels and the biliary tract. However, most unresectable liver cancers did not fit the criteria for these treatments. Therefore, other regional therapeutic option like external radiation therapy may be considered for local control in the liver or symptom palliation
Interventions
RADIATIONStereotactic Body Radiation Therapy
Radiation Dose: 48 Gy in 4 fractions in 2 weeks. A minimum of 48 hours should separate each treatment (e.g. every Tuesday and Friday). The dose is prescribed to the marginal isodose (80-90%) that encompasses the entire target lesion (GTV). Treatment will be delivered using a linear accelerator. For verification of the accuracy of these external skin fiducial markers, 10 patients will also have implanted internal gold coil markers. The implantable gold coil markers will be implanted into the liver in the proximity of the target lesions via a percutaneous transhepatic route under fluoroscopy guidance.
Sponsors
Alberta Health services
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically conformation of liver malignancy * Solitary or multiple liver tumors amenable to SBRT * No jaundice or liver dysfunction * For metastases, the primary tumor site has been adequately treated. * For primary hepatoma, no extra-hepatic disease * Karnofsky \> 70
Exclusion criteria
* no extra-hepatic disease * Liver failure or inadequate liver function * Ascites * Previous radiation therapy to the liver * lesions invading major blood vessels in the porta region * Contraindication to receive radiation therapy in the liver
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate to SBRT | 3-6 Months |
Secondary
| Measure | Time frame |
|---|---|
| Treatment Related Toxicity | 12 months |
Countries
Canada
Contacts
Primary ContactRobert Nordal, M.D.
Outcome results
None listed