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

NCT ID: NCT00691691

Last Updated: 2012-01-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30

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

Conditions

Liver Tumors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

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.

Group Type: EXPERIMENTAL

Stereotactic Body Radiation Therapy

Intervention Type: RADIATION

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.

Interventions

Stereotactic 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.

Intervention Type: RADIATION

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alberta Health services

OTHER

Sponsor Role: lead

Responsible Party

Tom Baker Cancer Centre

Principal Investigators

Robert Nordal, M.D.

Role: PRINCIPAL_INVESTIGATOR

Tom Baker Cancer Centre

Locations

Tom Baker Cancer Centre

Calgary, Alberta, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Robert Nordal, M.D.

Role: CONTACT

Robert.Nordal@albertahealthservices.ca

403-521-3095

Facility Contacts

Robert Nordal, M.D.

Role: primary

Robert.Nordal@albertahealthservices.ca

403-521-3077

Other Identifiers

18740

Identifier Type: -

Identifier Source: secondary_id

18740

Identifier Type: -

Identifier Source: org_study_id