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

Liver Tumors Clinical Trial

Official title:

A Phase II Study of Fractionated Stereotactic Body Radiation Therapy (SBRT) in the Treatment of Liver Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00691691
• Other study ID #: 18740
• Secondary ID: 18740
• Status: Recruiting
• Phase: Phase 2
• First received: June 3, 2008
• Last updated: January 18, 2012
• Start date: November 2007

Study information

• Verified date: August 2011
• Source: AHS Cancer Control Alberta
• Contact: Robert Nordal, M.D.
• Phone: 403-521-3095
• Email: Robert.Nordal[@]albertahealthservices.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 71
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Neoplasms
• Liver Tumors

Intervention

Radiation:
• 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.

Locations

Country	Name	City	State
Canada	Tom Baker Cancer Centre	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
Alberta Health Services

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate to SBRT		3-6 Months	No
Secondary	Treatment Related Toxicity		12 months	Yes