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Frameless Stereotactic Radiosurgery for Brain Metastases

This study is currently recruiting participants.
Verified August 2011 by Alberta Health Services
Sponsor:
Collaborator:
Tom Baker Cancer Centre
Information provided by:
Alberta Health Services
ClinicalTrials.gov Identifier:
NCT01476878
First received: July 9, 2010
Last updated: November 18, 2011
Last verified: August 2011
History of Changes

July 9, 2010
November 18, 2011
January 2010
January 2012   (final data collection date for primary outcome measure)
Quantification of patient movement occurring during treatment. [ Time Frame: overall ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01476878 on ClinicalTrials.gov Archive Site
  • Local tumour control [ Time Frame: overall ] [ Designated as safety issue: Yes ]
  • risk of complication (radionecrosis) [ Time Frame: overall ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Frameless Stereotactic Radiosurgery for Brain Metastases
Frameless Stereotactic Radiosurgery for Brain Metastases

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.
Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Brain Metastases
Device: Frameless Stereotactic Radiosurgery with radiation mask
Linac-based radiosurgery using a thermoplastic mask (single treatment)
Other Name: Frameless Stereotactic Radiosurgery using radiation mask
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.
Intervention: Device: Frameless Stereotactic Radiosurgery with radiation mask
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
January 2012
January 2012   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact: Jon-Paul Voroney, Phd. M.D. 403-521-3164 Jon-Paul.Voroney@albertahealthservices.ca
Canada
 
NCT01476878
FRAMELESS SRS
Yes
Jon-Paul Voroney, Tom Baker Cancer Centre
Alberta Health Services
Tom Baker Cancer Centre
Principal Investigator: Jon-Paul Voroney, MD Tom Baker Cancer Centre
Alberta Health Services
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP