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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2011 by AHS Cancer Control Alberta.
Recruitment status was:  Recruiting
Information provided by:
AHS Cancer Control Alberta Identifier:
First received: June 3, 2008
Last updated: January 18, 2012
Last verified: August 2011
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

Condition Intervention Phase
Liver Tumors
Radiation: Stereotactic Body Radiation Therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Fractionated Stereotactic Body Radiation Therapy (SBRT) in the Treatment of Liver Tumors

Resource links provided by NLM:

Further study details as provided by AHS Cancer Control Alberta:

Primary Outcome Measures:
  • Response rate to SBRT [ Time Frame: 3-6 Months ]

Secondary Outcome Measures:
  • Treatment Related Toxicity [ Time Frame: 12 months ]

Estimated Enrollment: 71
Study Start Date: November 2007
Arms Assigned Interventions
Experimental: 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.
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
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Please refer to this study by its identifier: NCT00691691

Contact: Robert Nordal, M.D. 403-521-3095

Canada, Alberta
Tom Baker Cancer Centre Recruiting
Calgary, Alberta, Canada, T2N 4N2
Contact: Robert Nordal, M.D.    403-521-3077   
Principal Investigator: Robert Nordal, M.D.         
Sponsors and Collaborators
Alberta Health Services
Principal Investigator: Robert Nordal, M.D. Tom Baker Cancer Centre
  More Information

Responsible Party: Dr. Robert Nordal, Tom Baker Cancer Centre Identifier: NCT00691691     History of Changes
Other Study ID Numbers: 18740
Study First Received: June 3, 2008
Last Updated: January 18, 2012

Keywords provided by AHS Cancer Control Alberta:
Liver malignancy
Stereotactic Body Radiation Therapy
Efficacy of SBRT in liver tumors
Hepatic toxicity with SBRT

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases processed this record on April 28, 2017