Brain MetastasesPhase 1/2NCT01476878
Frameless Stereotactic Radiosurgery for Brain Metastases
A Phase 1/2 study testing Frameless Stereotactic Radiosurgery with radiation mask in people with Brain Metastases, run by Alberta Health services at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastases
- What is being tested?
- Frameless Stereotactic Radiosurgery with radiation mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2010to Jan 2012
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2
Jon-Paul Voroney, PHD. M.D.
Harold Lau, M.D.
About this study
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.
- Conditions
- Brain Metastases
- Being tested
- Frameless Stereotactic Radiosurgery with radiation mask
- Keywords
- Radiosurgery, Frameless radiosurgery, Accuracy
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frameless Stereotactic Radiosurgery with radiation maskDevice
Also called Frameless Stereotactic Radiosurgery using radiation mask
Linac-based radiosurgery using a thermoplastic mask (single treatment)
| Study group | Role | What they receive |
|---|---|---|
| Open Arm | Experimental | 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. Receives: Device: Frameless Stereotactic Radiosurgery with radiation mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of patient movement occurring during treatment.
Measured: overall
Secondary outcomes (2)
Local tumour control
Measured: overall
risk of complication (radionecrosis)
Measured: overall
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startJan 2010
- Primary completionJan 2012 (estimated)
- Study completionJan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MetastasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alberta Health services
- Sponsor type
- University, hospital or other
- Collaborators
- Tom Baker Cancer Centre
- Investigators
- Jon-Paul Voroney, MD, Principal investigator, Tom Baker Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01476878
- Sponsor's protocol ID
- FRAMELESS SRS
- Status last verified
- Aug 2011
- First submitted
- 9 Jul 2010
- Last updated
- 22 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frameless Stereotactic Radiosurgery for Brain Metastases
- ClinicalTrials.gov ID
- NCT01476878
- Acronym / sponsor ID
- FRAMELESS SRS
- Conditions
- Brain Metastases
- Keywords
- Radiosurgery, Frameless radiosurgery, Accuracy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Alberta Health servicesUniversity, hospital or other
- Collaborators
- Tom Baker Cancer Centre
- Study start
- Jan 2010
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Jan 2012 (estimated)
- First posted
- 22 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Arm | Experimental | Device: Frameless Stereotactic Radiosurgery with radiation maskEach 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- None of the lesions is abutting or within critical neurological structures: *brainstem
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Frameless Stereotactic Radiosurgery with radiation maskAlso: Frameless Stereotactic Radiosurgery using radiation maskLinac-based radiosurgery using a thermoplastic mask (single treatment) | Device | Open Arm |
Primary outcome
Quantification of patient movement occurring during treatment.
Time frame: overall
2 secondary outcomes
Local tumour control
Time frame: overall
risk of complication (radionecrosis)
Time frame: overall
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jon-Paul Voroney, MD principal investigator
Tom Baker Cancer Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Frameless Stereotactic Radiosurgery with radiation mask in people with Brain Metastases, run by Alberta Health services at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jon-Paul Voroney, Phd. M.D. (403-521-3164, Jon-Paul.Voroney@albertahealthservices.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of patient movement occurring during treatment. (time frame: overall). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2011; AzTrials last refreshed its copy on 31 Oct 2026.