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Trial Title:
Frameless Stereotactic Radiosurgery for Brain Metastases
NCT ID:
NCT01476878
Condition:
Brain Metastases
Conditions: Official terms:
Neoplasm Metastasis
Brain Neoplasms
Conditions: Keywords:
Radiosurgery
Frameless radiosurgery
Accuracy
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Frameless Stereotactic Radiosurgery with radiation mask
Description:
Linac-based radiosurgery using a thermoplastic mask (single treatment)
Arm group label:
Open Arm
Other name:
Frameless Stereotactic Radiosurgery using radiation mask
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:
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).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Tom Baker Cancer Centre
Address:
City:
Calgary
Zip:
T2N 4N2
Country:
Canada
Status:
Recruiting
Investigator:
Last name:
Jon-Paul Voroney, PHD. M.D.
Email:
Principal Investigator
Investigator:
Last name:
Harold Lau, M.D.
Email:
Sub-Investigator
Start date:
January 2010
Completion date:
January 2012
Lead sponsor:
Agency:
Alberta Health services
Agency class:
Other
Collaborator:
Agency:
Tom Baker Cancer Centre
Agency class:
Other
Source:
AHS Cancer Control Alberta
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01476878
