Frameless Stereotactic Radiosurgery for Brain Metastases

November 18, 2011 updated by: Alberta Health services
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Recruiting
        • Tom Baker Cancer Centre
        • Principal Investigator:
          • Jon-Paul Voroney, PHD. M.D.
        • Sub-Investigator:
          • Harold Lau, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Frameless Stereotactic Radiosurgery using radiation mask

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quantification of patient movement occurring during treatment.
Time Frame: overall
overall

Secondary Outcome Measures

Outcome Measure
Time Frame
Local tumour control
Time Frame: overall
overall
risk of complication (radionecrosis)
Time Frame: overall
overall

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alberta Health services

Collaborators

Tom Baker Cancer Centre

Investigators

  • Principal Investigator: Jon-Paul Voroney, MD, Tom Baker Cancer Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Anticipated)

January 1, 2012

Study Completion (Anticipated)

January 1, 2012

Study Registration Dates

First Submitted

July 9, 2010

First Submitted That Met QC Criteria

November 18, 2011

First Posted (Estimate)

November 22, 2011

Study Record Updates

Last Update Posted (Estimate)

November 22, 2011

Last Update Submitted That Met QC Criteria

November 18, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FRAMELESS SRS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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