Frameless Stereotactic Radiosurgery for Brain Metastases

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by AHS Cancer Control Alberta.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Tom Baker Cancer Centre
Information provided by:
AHS Cancer Control Alberta
ClinicalTrials.gov Identifier:
NCT01476878
First received: July 9, 2010
Last updated: November 18, 2011
Last verified: August 2011
  Purpose

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 Intervention Phase
Brain Metastases
Device: Frameless Stereotactic Radiosurgery with radiation mask
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Frameless Stereotactic Radiosurgery for Brain Metastases

Resource links provided by NLM:


Further study details as provided by AHS Cancer Control Alberta:

Primary Outcome Measures:
  • Quantification of patient movement occurring during treatment. [ Time Frame: overall ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Local tumour control [ Time Frame: overall ] [ Designated as safety issue: Yes ]
  • risk of complication (radionecrosis) [ Time Frame: overall ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: January 2010
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01476878

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

Locations
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
AHS Cancer Control Alberta
Tom Baker Cancer Centre
Investigators
Principal Investigator: Jon-Paul Voroney, MD Tom Baker Cancer Centre
  More Information

No publications provided

Responsible Party: Jon-Paul Voroney, Tom Baker Cancer Centre
ClinicalTrials.gov Identifier: NCT01476878     History of Changes
Other Study ID Numbers: FRAMELESS SRS
Study First Received: July 9, 2010
Last Updated: November 18, 2011
Health Authority: Canada: Health Canada

Keywords provided by AHS Cancer Control Alberta:
Radiosurgery
Frameless radiosurgery
Accuracy

Additional relevant MeSH terms:
Brain Neoplasms
Neoplasm Metastasis
Brain Diseases
Central Nervous System Diseases
Central Nervous System Neoplasms
Neoplasms
Neoplasms by Site
Neoplastic Processes
Nervous System Diseases
Nervous System Neoplasms
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014