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Frameless Stereotactic Radiosurgery for Brain Metastases

Primary Purpose

Brain Metastases

Status
Unknown status
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Frameless Stereotactic Radiosurgery with radiation mask
Sponsored by
Alberta Health services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Metastases focused on measuring Radiosurgery, Frameless radiosurgery, Accuracy

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with brain metastases from a biopsy-proven primary extra-cranial tumor site, excluding lymphoma, germ cell, and small cell lung carcinoma histologies.
  • One to four metastases, and all lesions < 3.5 cm in maximal diameter. Extracranial metastases is of minimal volume or stable with treatment. - Karnofsky performance status ≥ 70

Exclusion Criteria:

  • None of the lesions is abutting or within critical neurological structures: *brainstem

    • optic chiasm
    • eye, and optic nerve.
  • The clearance between metastatic lesions and all critical structures must be at least 2 mm.
  • Patients must not have leptomeningeal disease.
  • Contraindications to imaging or radiation (e.g. pregnancy, elevated serum creatinine, allergy to contrast agents, severe claustrophobia, metal particles in the eye).

Sites / Locations

  • Tom Baker Cancer CentreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open Arm

Arm Description

Each study patient will receive high dose, single treatment radiation using a plastic mask instead of a head frame that pins into a patient's skull.

Outcomes

Primary Outcome Measures

Quantification of patient movement occurring during treatment.

Secondary Outcome Measures

Local tumour control
risk of complication (radionecrosis)

Full Information

First Posted
July 9, 2010
Last Updated
November 18, 2011
Sponsor
Alberta Health services
Collaborators
Tom Baker Cancer Centre
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1. Study Identification

Unique Protocol Identification Number
NCT01476878
Brief Title
Frameless Stereotactic Radiosurgery for Brain Metastases
Official Title
Frameless Stereotactic Radiosurgery for Brain Metastases
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2012 (Anticipated)
Study Completion Date
January 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Alberta Health services
Collaborators
Tom Baker Cancer Centre

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The investigators plan to study high dose, single treatment radiation, using a plastic mask instead of a head frame that pins into a patient's skull. The investigators need to (1) quantify set-up accuracy and patient motion during radiation treatment and (2) ensure that without the head frame the tumour control rate and risk of complications are similar to our previous experience using the head frame.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Metastases
Keywords
Radiosurgery, Frameless radiosurgery, Accuracy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Open Arm
Arm Type
Experimental
Arm Description
Each study patient will receive high dose, single treatment radiation using a plastic mask instead of a head frame that pins into a patient's skull.
Intervention Type
Device
Intervention Name(s)
Frameless Stereotactic Radiosurgery with radiation mask
Other Intervention Name(s)
Frameless Stereotactic Radiosurgery using radiation mask
Intervention Description
Linac-based radiosurgery using a thermoplastic mask (single treatment)
Primary Outcome Measure Information:
Title
Quantification of patient movement occurring during treatment.
Time Frame
overall
Secondary Outcome Measure Information:
Title
Local tumour control
Time Frame
overall
Title
risk of complication (radionecrosis)
Time Frame
overall

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with brain metastases from a biopsy-proven primary extra-cranial tumor site, excluding lymphoma, germ cell, and small cell lung carcinoma histologies. One to four metastases, and all lesions < 3.5 cm in maximal diameter. Extracranial metastases is of minimal volume or stable with treatment. - Karnofsky performance status ≥ 70 Exclusion Criteria: None of the lesions is abutting or within critical neurological structures: *brainstem optic chiasm eye, and optic nerve. The clearance between metastatic lesions and all critical structures must be at least 2 mm. Patients must not have leptomeningeal disease. Contraindications to imaging or radiation (e.g. pregnancy, elevated serum creatinine, allergy to contrast agents, severe claustrophobia, metal particles in the eye).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jon-Paul Voroney, Phd. M.D.
Phone
403-521-3164
Email
Jon-Paul.Voroney@albertahealthservices.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon-Paul Voroney, MD
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
Jon-Paul Voroney, PHD. M.D.
First Name & Middle Initial & Last Name & Degree
Harold Lau, M.D.

12. IPD Sharing Statement

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Frameless Stereotactic Radiosurgery for Brain Metastases

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