Frameless Stereotactic Radiosurgery for Brain Metastases

Phase 1

• Conditions: Brain Metastases
• Interventions: Device: Frameless Stereotactic Radiosurgery with radiation mask

• Registration Number: NCT01476878
• Lead Sponsor: Alberta Health services

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-07-09
• Status Verified: 2011-08
• Study First Submitted QC: 2011-11-18
• Last Update Submitted: 2011-11-18
• Study First Posted: 2011-11-22
• Last Update Posted: 2011-11-22
• Primary Completion: 2012-01
• Study Completion: 2012-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open Arm	Frameless Stereotactic Radiosurgery with radiation mask	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.

Primary Outcome Measures

Name	Time	Method
Quantification of patient movement occurring during treatment.	overall

Secondary Outcome Measures

Name	Time	Method
Local tumour control	overall
risk of complication (radionecrosis)	overall

Trial Locations

Locations (1)

Tom Baker Cancer Centre; 🇨🇦 Calgary, Alberta, Canada