Stereotactic Body Radiation Therapy (SBRT) in the Treatment of Liver Tumors

Phase 2

• Conditions: Liver Tumors
• Interventions: Radiation: Stereotactic Body Radiation Therapy

• Registration Number: NCT00691691
• Lead Sponsor: Alberta Health services

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2008-06-03
• Study First Submitted QC: 2008-06-04
• Study First Posted: 2008-06-05
• Status Verified: 2011-08
• Last Update Submitted: 2012-01-18
• Last Update Posted: 2012-01-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 71

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Stereotactic Body Radiation Therapy	Eligible patient will be treated with 48 Gy in 4 fractions encompassing the entire target lesion in 2 weeks with a minimum of 48 hours between each dose.

Primary Outcome Measures

Name	Time	Method
Response rate to SBRT	3-6 Months

Secondary Outcome Measures

Name	Time	Method
Treatment Related Toxicity	12 months

Trial Locations

Locations (1)

Tom Baker Cancer Centre; 🇨🇦 Calgary, Alberta, Canada