Frameless Stereotactic Radiosurgery for Brain Metastases

Brain Metastases Clinical Trial

Official title:

Frameless Stereotactic Radiosurgery for Brain Metastases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01476878
• Other study ID #: FRAMELESS SRS
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: July 9, 2010
• Last updated: November 18, 2011
• Start date: January 2010
• Est. completion date: January 2012

Study information

• Verified date: August 2011
• Source: AHS Cancer Control Alberta
• Contact: Jon-Paul Voroney, Phd. M.D.
• Phone: 403-521-3164
• Email: Jon-Paul.Voroney[@]albertahealthservices.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Neoplasm Metastasis

Intervention

Device:
• Frameless Stereotactic Radiosurgery with radiation mask
Linac-based radiosurgery using a thermoplastic mask (single treatment)

Locations

Country	Name	City	State
Canada	Tom Baker Cancer Centre	Calgary	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
Alberta Health Services	Tom Baker Cancer Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantification of patient movement occurring during treatment.		overall	Yes
Secondary	Local tumour control		overall	Yes
Secondary	risk of complication (radionecrosis)		overall	Yes