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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by AHS Cancer Control Alberta.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
AHS Cancer Control Alberta
ClinicalTrials.gov Identifier:
NCT00691691
First received: June 3, 2008
Last updated: January 18, 2012
Last verified: August 2011
  Purpose

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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Treatment Related Toxicity [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00691691

Contacts
Contact: Robert Nordal, M.D. 403-521-3095 Robert.Nordal@albertahealthservices.ca

Locations
Canada, Alberta
Tom Baker Cancer Centre Recruiting
Calgary, Alberta, Canada, T2N 4N2
Contact: Robert Nordal, M.D.    403-521-3077    Robert.Nordal@albertahealthservices.ca   
Principal Investigator: Robert Nordal, M.D.         
Sponsors and Collaborators
AHS Cancer Control Alberta
Investigators
Principal Investigator: Robert Nordal, M.D. Tom Baker Cancer Centre
  More Information

No publications provided

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

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:
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on September 29, 2014