Frameless Stereotactic Radiosurgery for Brain Metastases
This study is currently recruiting participants.
Verified August 2011 by Alberta Health Services
Sponsor:
Alberta Health Services
Collaborator:
Tom Baker Cancer Centre
Information provided by:
Alberta Health Services
ClinicalTrials.gov Identifier:
NCT01476878
First received: July 9, 2010
Last updated: November 18, 2011
Last verified: August 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain Metastases |
Device: Frameless Stereotactic Radiosurgery with radiation mask |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Frameless Stereotactic Radiosurgery for Brain Metastases |
Resource links provided by NLM:
Further study details as provided by Alberta Health Services:
Primary Outcome Measures:
- Quantification of patient movement occurring during treatment. [ Time Frame: overall ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Local tumour control [ Time Frame: overall ] [ Designated as safety issue: Yes ]
- risk of complication (radionecrosis) [ Time Frame: overall ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 20 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | January 2012 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01476878
Contacts
| Contact: Jon-Paul Voroney, Phd. M.D. | 403-521-3164 | Jon-Paul.Voroney@albertahealthservices.ca |
Locations
| Canada, Alberta | |
| Tom Baker Cancer Centre | Recruiting |
| Calgary, Alberta, Canada, T2N 4N2 | |
| Principal Investigator: Jon-Paul Voroney, PHD. M.D. | |
| Sub-Investigator: Harold Lau, M.D. | |
Sponsors and Collaborators
Alberta Health Services
Tom Baker Cancer Centre
Investigators
| Principal Investigator: | Jon-Paul Voroney, MD | Tom Baker Cancer Centre |
More Information
No publications provided
| Responsible Party: | Jon-Paul Voroney, Tom Baker Cancer Centre |
| ClinicalTrials.gov Identifier: | NCT01476878 History of Changes |
| Other Study ID Numbers: | FRAMELESS SRS |
| Study First Received: | July 9, 2010 |
| Last Updated: | November 18, 2011 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Alberta Health Services:
|
Radiosurgery Frameless radiosurgery Accuracy |
Additional relevant MeSH terms:
|
Neoplasm Metastasis Neoplasms, Second Primary Brain Neoplasms Neoplastic Processes Neoplasms Pathologic Processes |
Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Brain Diseases Central Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013