Brain (Nervous System) CancersPhase 2GK-LIVENCT07162246
Combined Gamma Knife/Linac Radiosurgery for Large Brain Tumors / Metastases
A Phase 2 study testing Radiation Therapy in people with Brain (Nervous System) Cancers and Brain Metastasases, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
When cancer spreads to the brain, doctors often use a precise type of radiation therapy called stereotactic radiosurgery (SRS) to treat these tumors. This treatment can effectively control brain tumors while helping protect healthy brain tissue. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain (Nervous System) Cancers, Brain Metastasases, SRS
- What is being tested?
- Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 14 Jul 2025to Jun 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Presence of up to two large intracranial lesions
- Up to 10 (previously untreated, or progressing after previous treatment) brain metastases at the time of enrollment on the diagnostic MRI (which includes the ILLs) to be treated with SRS/HSRS
- Age => 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Expected survival >3 months
- Patients that are deemed suitable for both GK and Linac based treatment
- Patients that are able to hold systemic cancer chemotherapy/immunotherapy at least 2 days prior and following an SRS fraction
Who cannot join
- Prior SRS to the ILLs
- Prior WBRT, or plan for concurrent WBRT with the protocol treatment
- Presence or history of any leptomeningeal/pachymeningeal disease
- Metastatic disease within the ventricles of the brain or corpus callosum
- Small cell, hematopoietic or germ cell primaries
- Patient with absolutely contraindications for MRI
Show all 9Show fewer
- Severe symptoms that preclude MRI or treatment using standard procedures for Linac or GK
- Pregnant or lactating patient
- Inability or unwillingness to undergo informed consent or post-treatment follow-up
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Aimee Theriault contact
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N3M5
Aimee Theriault, 4164806100 ext. x67364, aimee.theriault@sunnybrook.ca
About this study
Official title: Combined Gamma Knife/Linac Hypofractionated Stereotactic Radiosurgery for Large Intracranial VolumEs (GK-LIVE): A Prospective Phase II Single-Arm Trial
When cancer spreads to the brain, doctors often use a precise type of radiation therapy called stereotactic radiosurgery (SRS) to treat these tumors. This treatment can effectively control brain tumors while helping protect healthy brain tissue. However, when brain tumors or the areas where tumors were surgically removed are larger, treatment outcomes in terms of side effects and tumour control can become worse. Specifically, standard SRS on larger areas can have lower tumour control and higher risk of side effects, particularly a condition called radiation necrosis, which can cause swelling and damage in nearby healthy brain tissue.
Currently at Sunnybrook, large brain tumors are typically treated with SRS spread over 5 daily treatments using a machine called a linear accelerator. While this approach works well for many patients, it may be possible to improve results by combining two different types of radiation therapy machines - the linear accelerator and another specialized machine called the Gamma Knife.
Read more
In this study, the investigators want to test a new treatment approach where patients first receive 4 daily treatments using the linear accelerator, followed by a 1-2 week break, and then a final treatment using the Gamma Knife. The break between treatments allows the study doctors to take new scans and precisely target any remaining tumor, which may shrink during the break, thereby potentially reducing the amount of healthy brain tissue exposed to radiation. The Gamma Knife is also particularly good at delivering very precise radiation while sparing nearby healthy tissue. Lastly, there may be unique biological mechanisms between the two technologies that could be taken advantage of, by combining the technologies in the participant's treatment plan, to improve cancer control.
The investigators believe this combined approach might help achieve better tumor control while reducing the risk of side effects compared to using just the linear accelerator. This study will help the investigators understand if this new treatment strategy is safe and effective for patients with large brain tumors or surgical cavities, and whether it leads to better outcomes than the current treatment approach.
- Conditions
- Brain (Nervous System) Cancers, Brain Metastasases, SRS
- Being tested
- Radiation Therapy
- Medical subject headings
- Neurologic Manifestations, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation TherapyRadiation
Adaptive radiation therapy with GK boost
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Not described Receives: Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of late local complication (LLC)
Measured: From end of protocol treatment to development of local failure or symptomatic ISRS Grade => 2 radionecrosis (assessed up to 24 months)
Secondary outcomes (7)
Overall Survival
Measured: Completion of protocol treatment to date of death (assessed up to 24 months)
Distant Brain Progression-Free Survival
Measured: Date of protocol treatment to either appearance of additional metastatic disease within the brain, or death (assessed up to 24 months)
Cumulative Incidence of Local Failure
Measured: Date of completion of protocol treatment to local failure (assessed up to 24 months)
Cumulative Incidence of Radiation Necrosis
Measured: Date of protocol treatment to development of symptomatic radiation necrosis (assessed up to 24 months)
Treatment-Related Toxicity
From changes to baseline, as defined by CTCAE v5.0
Measured: Throughout study participation and assessed up to 24 months following treatment completion
Change in Neurological Function
Through changes in the NANO scale
Measured: From enrollment onwards, up until 24 months after protocol treatment completion
Health-Related Quality of Life
Through changes in responses to health-related quality of life surveys completed during study participation
Measured: From enrollment onwards, up until 24 months after protocol treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start14 Jul 2025
- Primary completionJun 2029 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain (Nervous System) CancersStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07162246
- Sponsor's protocol ID
- GK-LIVE
- Acronym
- GK-LIVE
- Status last verified
- Aug 2025
- First submitted
- 7 Aug 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Gamma Knife/Linac Hypofractionated Stereotactic Radiosurgery for Large Intracranial VolumEs (GK-LIVE): A Prospective Phase II Single-Arm Trial
- ClinicalTrials.gov ID
- NCT07162246
- Acronym / sponsor ID
- GK-LIVE / GK-LIVE
- Conditions
- Brain (Nervous System) Cancers, Brain Metastasases, SRS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 14 Jul 2025 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 9 Sep 2025 (actual)
- 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.
When cancer spreads to the brain, doctors often use a precise type of radiation therapy called stereotactic radiosurgery (SRS) to treat these tumors. This treatment can effectively control brain tumors while helping protect healthy brain tissue. However, when brain tumors or the areas where tumors were surgically removed are larger, treatment outcomes in terms of side effects and tumour control can become worse. Specifically, standard SRS on larger areas can have lower tumour control and higher risk of side effects, particularly a condition called radiation necrosis, which can cause swelling and damage in nearby healthy brain tissue.
Currently at Sunnybrook, large brain tumors are typically treated with SRS spread over 5 daily treatments using a machine called a linear accelerator. While this approach works well for many patients, it may be possible to improve results by combining two different types of radiation therapy machines - the linear accelerator and another specialized machine called the Gamma Knife.
In this study, the investigators want to test a new treatment approach where patients first receive 4 daily treatments using the linear accelerator, followed by a 1-2 week break, and then a final treatment using the Gamma Knife. The break between treatments allows the study doctors to take new scans and precisely target any remaining tumor, which may shrink during the break, thereby potentially reducing the amount of healthy brain tissue exposed to radiation. The Gamma Knife is also particularly good at delivering very precise radiation while sparing nearby healthy tissue. Lastly, there may be unique biological mechanisms between the two technologies that could be taken advantage of, by combining the technologies in the participant's treatment plan, to improve cancer control.
The investigators believe this combined approach might help achieve better tumor control while reducing the risk of side effects compared to using just the linear accelerator. This study will help the investigators understand if this new treatment strategy is safe and effective for patients with large brain tumors or surgical cavities, and whether it leads to better outcomes than the current treatment approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Radiation: Radiation Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Presence of up to two large intracranial lesions
- Up to 10 (previously untreated, or progressing after previous treatment) brain metastases at the time of enrollment on the diagnostic MRI (which includes the ILLs) to be treated with SRS/HSRS
- Age => 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Expected survival >3 months
Key exclusion criteria (9 listed)
- Prior SRS to the ILLs
- Prior WBRT, or plan for concurrent WBRT with the protocol treatment
- Presence or history of any leptomeningeal/pachymeningeal disease
- Metastatic disease within the ventricles of the brain or corpus callosum
- Small cell, hematopoietic or germ cell primaries
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 |
|---|---|---|
| Radiation TherapyAdaptive radiation therapy with GK boost | Radiation | Treatment Arm |
Primary outcome
Cumulative incidence of late local complication (LLC)
Time frame: From end of protocol treatment to development of local failure or symptomatic ISRS Grade => 2 radionecrosis (assessed up to 24 months)
7 secondary outcomes
Overall Survival
Time frame: Completion of protocol treatment to date of death (assessed up to 24 months)
Distant Brain Progression-Free Survival
Time frame: Date of protocol treatment to either appearance of additional metastatic disease within the brain, or death (assessed up to 24 months)
Cumulative Incidence of Local Failure
Time frame: Date of completion of protocol treatment to local failure (assessed up to 24 months)
Cumulative Incidence of Radiation Necrosis
Time frame: Date of protocol treatment to development of symptomatic radiation necrosis (assessed up to 24 months)
Treatment-Related Toxicity
Time frame: Throughout study participation and assessed up to 24 months following treatment completion
Change in Neurological Function
Time frame: From enrollment onwards, up until 24 months after protocol treatment completion
Health-Related Quality of Life
Time frame: From enrollment onwards, up until 24 months after protocol treatment completion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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.
Aimee Theriault contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radiation Therapy in people with Brain (Nervous System) Cancers and Brain Metastasases, run by Sunnybrook Health Sciences Centre 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 7 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 9 Sep 2025. 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 phase mean?
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hanbo Chan, MD (4164804974, hanbo.chen@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence of late local complication (LLC) (time frame: From end of protocol treatment to development of local failure or symptomatic ISRS Grade => 2 radionecrosis (assessed up to 24 months)). 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 9 Sep 2025.