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Trial Title:
Stereotactic Body Radiation Therapy (SBRT) in the Treatment of Liver Tumors
NCT ID:
NCT00691691
Condition:
Liver Tumors
Conditions: Official terms:
Liver Neoplasms
Conditions: Keywords:
Liver malignancy
Stereotactic Body Radiation Therapy
Efficacy of SBRT in liver tumors
Hepatic toxicity with SBRT
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Stereotactic Body Radiation Therapy
Description:
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.
Arm group label:
1
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
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Tom Baker Cancer Centre
Address:
City:
Calgary
Zip:
T2N 4N2
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Robert Nordal, M.D.
Phone:
403-521-3077
Email:
Robert.Nordal@albertahealthservices.ca
Investigator:
Last name:
Robert Nordal, M.D.
Email:
Principal Investigator
Start date:
November 2007
Lead sponsor:
Agency:
Alberta Health services
Agency class:
Other
Source:
AHS Cancer Control Alberta
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00691691
