Frameless Stereotactic Radiosurgery for Brain Metastases
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|ClinicalTrials.gov Identifier: NCT01476878|
Recruitment Status : Unknown
Verified August 2011 by AHS Cancer Control Alberta.
Recruitment status was: Recruiting
First Posted : November 22, 2011
Last Update Posted : November 22, 2011
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|Condition or disease||Intervention/treatment||Phase|
|Brain Metastases||Device: Frameless Stereotactic Radiosurgery with radiation mask||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Frameless Stereotactic Radiosurgery for Brain Metastases|
|Study Start Date :||January 2010|
|Estimated Primary Completion Date :||January 2012|
|Estimated Study Completion Date :||January 2012|
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
- Quantification of patient movement occurring during treatment. [ Time Frame: overall ]
- Local tumour control [ Time Frame: overall ]
- risk of complication (radionecrosis) [ Time Frame: overall ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01476878
|Contact: Jon-Paul Voroney, Phd. M.D.||403-521-3164||Jon-Paul.Voroney@albertahealthservices.ca|
|Tom Baker Cancer Centre||Recruiting|
|Calgary, Alberta, Canada, T2N 4N2|
|Principal Investigator: Jon-Paul Voroney, PHD. M.D.|
|Sub-Investigator: Harold Lau, M.D.|
|Principal Investigator:||Jon-Paul Voroney, MD||Tom Baker Cancer Centre|
|Responsible Party:||Jon-Paul Voroney, Tom Baker Cancer Centre|
|Other Study ID Numbers:||
|First Posted:||November 22, 2011 Key Record Dates|
|Last Update Posted:||November 22, 2011|
|Last Verified:||August 2011|
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Central Nervous System Diseases
Nervous System Diseases