Recruiting
Phase 2

SBRT

Sponsor:

Alberta Health services

Code:

NCT00691691

Conditions

Liver Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Stereotactic Body Radiation Therapy

Study Details

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 ID

NCT00691691

Start date

Nov, 2007

Status verified date

Aug, 2011

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

71 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

Tom Baker Cancer Centre

Recruiting

Calgary, Alberta, Canada, T2N 4N2

Contacts

Principal Investigator:

Robert Nordal, M.D.

More Information

Sponsor

Alberta Health services

Last update posted

Jan 19, 2012

Last verified

Aug, 2011

Keywords

  • Liver malignancy
  • Stereotactic Body Radiation Therapy
  • Efficacy of SBRT in liver tumors
  • Hepatic toxicity with SBRT

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Alberta Health services on 2012-01-19.