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

Primary Purpose

Liver Tumors

Status
Unknown status
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Stereotactic Body Radiation Therapy
Sponsored by
Alberta Health services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Tumors focused on measuring Liver malignancy, Stereotactic Body Radiation Therapy, Efficacy of SBRT in liver tumors, Hepatic toxicity with SBRT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tom Baker Cancer CentreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

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.

Outcomes

Primary Outcome Measures

Response rate to SBRT

Secondary Outcome Measures

Treatment Related Toxicity

Full Information

First Posted
June 3, 2008
Last Updated
January 18, 2012
Sponsor
Alberta Health services
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1. Study Identification

Unique Protocol Identification Number
NCT00691691
Brief Title
Stereotactic Body Radiation Therapy (SBRT) in the Treatment of Liver Tumors
Official Title
A Phase II Study of Fractionated Stereotactic Body Radiation Therapy (SBRT) in the Treatment of Liver Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Unknown status
Study Start Date
November 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Alberta Health services

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Tumors
Keywords
Liver malignancy, Stereotactic Body Radiation Therapy, Efficacy of SBRT in liver tumors, Hepatic toxicity with SBRT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
71 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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 Type
Radiation
Intervention Name(s)
Stereotactic Body Radiation Therapy
Intervention 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.
Primary Outcome Measure Information:
Title
Response rate to SBRT
Time Frame
3-6 Months
Secondary Outcome Measure Information:
Title
Treatment Related Toxicity
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robert Nordal, M.D.
Phone
403-521-3095
Email
Robert.Nordal@albertahealthservices.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Nordal, M.D.
Organizational Affiliation
Tom Baker Cancer Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Nordal, M.D.
Phone
403-521-3077
Email
Robert.Nordal@albertahealthservices.ca
First Name & Middle Initial & Last Name & Degree
Robert Nordal, M.D.

12. IPD Sharing Statement

Learn more about this trial

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

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