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Stereotactic Body Radiation Therapy (SBRT) in the Treatment of Liver Tumors
Conditions
Liver Tumors
Conditions: official terms
Liver Neoplasms
Conditions: Keywords
Liver malignancy, Stereotactic Body Radiation Therapy, Efficacy of SBRT in liver tumors, Hepatic toxicity with SBRT
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Stereotactic Body Radiation Therapy
Type: Radiation
Overall Status
Recruiting
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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
- 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
Location
Tom Baker Cancer Centre
Calgary, Alberta, Canada
Status: Recruiting
Contact: Robert Nordal, M.D. - 403-521-3077 - Robert.Nordal@albertahealthservices.ca
Start Date
November 2007
Sponsors
Alberta Health Services
Source
AHS Cancer Control Alberta
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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