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Frameless Stereotactic Radiosurgery for Brain Metastases
Conditions
Brain Metastases
Conditions: official terms
Brain Neoplasms - Neoplasm Metastasis
Conditions: Keywords
Radiosurgery, Frameless radiosurgery, Accuracy
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Frameless Stereotactic Radiosurgery with radiation mask
Type: Device
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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).
- 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).
Location
Tom Baker Cancer Centre
Calgary, Alberta, Canada
Status: Recruiting
Start Date
January 2010
Completion Date
January 2012
Sponsors
Alberta Health Services
Source
AHS Cancer Control Alberta
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page