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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00691691
Recruitment Status : Unknown
Verified August 2011 by AHS Cancer Control Alberta.
Recruitment status was:  Recruiting
First Posted : June 5, 2008
Last Update Posted : January 19, 2012
Information provided by:
AHS Cancer Control Alberta

Tracking Information
First Submitted Date  ICMJE June 3, 2008
First Posted Date  ICMJE June 5, 2008
Last Update Posted Date January 19, 2012
Study Start Date  ICMJE November 2007
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2008)
Response rate to SBRT [ Time Frame: 3-6 Months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00691691 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2008)
Treatment Related Toxicity [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Stereotactic Body Radiation Therapy (SBRT) in the Treatment of Liver Tumors
Official Title  ICMJE A Phase II Study of Fractionated Stereotactic Body Radiation Therapy (SBRT) in the Treatment of Liver Tumors
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Liver Tumors
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Radiation: Stereotactic Body Radiation Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 4, 2008)
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00691691
Other Study ID Numbers  ICMJE 18740
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Robert Nordal, Tom Baker Cancer Centre
Study Sponsor  ICMJE Alberta Health Services
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Robert Nordal, M.D. Tom Baker Cancer Centre
PRS Account AHS Cancer Control Alberta
Verification Date August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP