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Frameless Stereotactic Radiosurgery for Brain Metastases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01476878
Recruitment Status : Unknown
Verified August 2011 by AHS Cancer Control Alberta.
Recruitment status was:  Recruiting
First Posted : November 22, 2011
Last Update Posted : November 22, 2011
Sponsor:
Collaborator:
Tom Baker Cancer Centre
Information provided by:
AHS Cancer Control Alberta

Study Description
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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.

Condition or disease Intervention/treatment Phase
Brain Metastases Device: Frameless Stereotactic Radiosurgery with radiation mask Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Frameless Stereotactic Radiosurgery for Brain Metastases
Study Start Date : January 2010
Estimated Primary Completion Date : January 2012
Estimated Study Completion Date : January 2012
Arms and Interventions
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Arm Intervention/treatment
Experimental: Open Arm
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.
 Device: Frameless Stereotactic Radiosurgery with radiation mask
Linac-based radiosurgery using a thermoplastic mask (single treatment)
Other Name: Frameless Stereotactic Radiosurgery using radiation mask


Outcome Measures
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Primary Outcome Measures :
  1. Quantification of patient movement occurring during treatment. [ Time Frame: overall ]

Secondary Outcome Measures :
  1. Local tumour control [ Time Frame: overall ]
  2. risk of complication (radionecrosis) [ Time Frame: overall ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01476878


Contacts
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Contact: Jon-Paul Voroney, Phd. M.D. 403-521-3164 Jon-Paul.Voroney@albertahealthservices.ca

Locations
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Canada, Alberta
Tom Baker Cancer Centre Recruiting
Calgary, Alberta, Canada, T2N 4N2
Principal Investigator: Jon-Paul Voroney, PHD. M.D.         
Sub-Investigator: Harold Lau, M.D.         
Sponsors and Collaborators
Alberta Health services
Tom Baker Cancer Centre
Investigators
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Principal Investigator: Jon-Paul Voroney, MD Tom Baker Cancer Centre
More Information
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Responsible Party: Jon-Paul Voroney, Tom Baker Cancer Centre
ClinicalTrials.gov Identifier: NCT01476878    
Other Study ID Numbers: FRAMELESS SRS
First Posted: November 22, 2011    Key Record Dates
Last Update Posted: November 22, 2011
Last Verified: August 2011
Keywords provided by AHS Cancer Control Alberta:
Radiosurgery
Frameless radiosurgery
Accuracy
Additional relevant MeSH terms:
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Neoplasm Metastasis
Brain Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Central Nervous System Neoplasms
 Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases