Brain MetastasesPhase 3NCT04474925
Pre- Versus Post-operative SRS for Resectable Brain Metastases
A Phase 3 study testing Brain Surgery and Stereotactic Radiosurgery in people with Brain Metastases, run by AHS Cancer Control Alberta at 1 site in Canada.
Trial summary
The purpose of this study is to determine if performing radiotherapy (SRS) prior to surgery results in better treatment outcomes than performing surgery before radiotherapy for patients with brain metastases. Brain metastases occur when cancer cells from a primary cancer (e.g. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Brain Metastases
- What is being tested?
- Brain Surgery and Stereotactic Radiosurgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- 27 Sep 2021to 7 Apr 2025
- Phase
- Phase 3
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Pathologically-proven primary malignancy
- ECOG 0-2
- Ability to complete neurocognitive testing without assistance from family or friends.
- Previous SRS to lesions other than the one being resected is allowed
- Patients of childbearing / reproductive potential must have a negative urine or serum pregnancy test ≤7 days before enrollment
- Participants capable of giving informed consent, or if appropriate participants having an acceptable individual capable of giving consent
Who cannot join
- Patients who have received prior WBRT, or SRS to the lesion being resected at time of study accrual
- Patients unable to undergo MRI scan (e.g. pacemaker)
- Leptomeningeal disease
- Germ cell tumor, small cell lung cancer or hematological primary malignancy
Trial locations and contacts
1 site in 1 country.
Canada1 site
Tom Baker Cancer Centre/Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta
About this study
Official title: A Randomized Controlled Trial of Pre-operative Versus Post-operative Stereotactic Radiosurgery for Patients With Surgically Resectable Brain Metastases
The purpose of this study is to determine if performing radiotherapy (SRS) prior to surgery results in better treatment outcomes than performing surgery before radiotherapy for patients with brain metastases.
Brain metastases occur when cancer cells from a primary cancer (e.g. lung, breast, colon) travel through the bloodstream and spread (metastasize) to the brain. As these new tumors grow they apply pressure and change how healthy brain tissue works. This can lead to a loss of brain function and worsening quality of life. Treatments for patients whose cancer has spread to the brain is often surgery, radiation therapy (radiotherapy) or a combination of both.
Read more
Surgery is one the main treatments for brain tumors. To remove the tumor, a neurosurgeon makes an opening in the skull and attempts to the remove the entire tumor. If the tumor is too close to important brain tissue, the surgeon may attempt to remove part of the tumor. Removal of the tumor from the brain tissue is called resection. The complete or partial removal of tumor helps to relieve symptoms by reducing pressure on healthy tissues and reduces the amount of tumor that needs to be treated by radiotherapy.
One type of radiotherapy used to treat brain metastases is stereotactic radiosurgery (SRS). SRS uses many focused radiation beams to treat tumors within the brain. Unlike surgery, there is no incision or cut being made. Instead, SRS uses an accurate map of your brain to deliver a precise beam of radiation to the tumors. The radiation damages the tumor cells forcing them to shrink and die off. The focused radiation beams also limit damage to healthy brain tissue minimizing side effects.
Surgery followed by radiotherapy is a standard treatment for brain metastases. However, there are still risks associated with the combination of treatments. This study plans to investigate whether performing surgery prior to SRS results in improved quality of life and decreased side effects.
- Conditions
- Brain Metastases
- Being tested
- Brain Surgery, Stereotactic Radiosurgery
- Keywords
- Neurosurgery, Stereotactic Radiosurgery
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain SurgeryProcedure or surgery
Surgery to remove brain metastases
Stereotactic RadiosurgeryRadiation
Also called SRS
SRS uses many focused radiation beams to treat tumors within the brain
| Study group | Role | What they receive |
|---|---|---|
| Surgical Resection followed by SRS (Non-Experimental) | Active comparator | Surgical Resection followed by SRS within 3 weeks of surgery date. Receives: Procedure: Brain Surgery; Radiation: Stereotactic Radiosurgery |
| SRS followed by Surgical Resection (Experimental) | Experimental | SRS followed by surgery within 1 week of radiotherapy end date. Receives: Procedure: Brain Surgery; Radiation: Stereotactic Radiosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Control
To compare local control (in months) of pre-operative versus post-operative SRS
Measured: This will be assessed at 12 months
Secondary outcomes (7)
Local Control
To compare local control (in months) of pre-operative versus post-operative SRS
Measured: This will be assessed at 6 and 24 months.
Distant Brain Recurrence Rate
To compare Distant Brain Recurrence Rate (%) of pre-operative versus post-operative SRS
Measured: This will be assessed at 6,12 and 24 months.
Leptomeningeal Recurrence Rate
To compare the Leptomeningeal Recurrence Rate (%) of pre-operative versus post-operative SRS
Measured: This will be assessed at 6,12 and 24 months.
Overall Survival
Overall survival will be compared between both treatment arms
Measured: This will be assessed at 6,12 and 24 months.
Hopkins Verbal Learning Test
Participants are scored using a points based system on Total Recall, Delayed Recall, Retention (% retained), and a Recognition Discrimination Index.
Measured: This will be assessed at 3,6,9,12,16 and 24 months.
Controlled Oral Word Association
Participants are scored on their ability to generate words starting with a specific letter in a one minute timeframe.
Measured: This will be assessed at 3,6,9,12,16 and 24 months.
Trial Making Tests
Participants are scored on their ability to complete the test within a certain timeframe.
Measured: This will be assessed at 3,6,9,12,16 and 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start27 Sep 2021
- Primary completion7 Apr 2025
- Study completion7 Apr 2025
Why it stopped: Insufficient accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04474925
- Sponsor's protocol ID
- IIT-0010
- Status last verified
- Jul 2025
- First submitted
- 14 Jul 2020
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Das S, Faruqi S, Nordal R, Starreveld Y, Kelly J, Bowden G, Amanie J, Fairchild A, Lim G, Loewen S, Rowe L, Wallace C, Ghosh S, Patel S. A phase III, multicenter, randomized controlled trial of preoperative versus postoperative stereotactic radiosurgery for patients with surgically resectable brain metastases. BMC Cancer. 2022 Dec 30;22(1):1368. doi: 10.1186/s12885-022-10480-z.
PubMed 36585629
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Pre-operative Versus Post-operative Stereotactic Radiosurgery for Patients With Surgically Resectable Brain Metastases
- ClinicalTrials.gov ID
- NCT04474925
- Acronym / sponsor ID
- IIT-0010
- Conditions
- Brain Metastases
- Keywords
- Neurosurgery, Stereotactic Radiosurgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient accrual
- Enrolment
- 8 participants (actual)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Study start
- 27 Sep 2021 (actual)
- Primary completion
- 7 Apr 2025 (actual)
- Study completion
- 7 Apr 2025 (actual)
- First posted
- 17 Jul 2020 (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.
The purpose of this study is to determine if performing radiotherapy (SRS) prior to surgery results in better treatment outcomes than performing surgery before radiotherapy for patients with brain metastases.
Brain metastases occur when cancer cells from a primary cancer (e.g. lung, breast, colon) travel through the bloodstream and spread (metastasize) to the brain. As these new tumors grow they apply pressure and change how healthy brain tissue works. This can lead to a loss of brain function and worsening quality of life. Treatments for patients whose cancer has spread to the brain is often surgery, radiation therapy (radiotherapy) or a combination of both.
Surgery is one the main treatments for brain tumors. To remove the tumor, a neurosurgeon makes an opening in the skull and attempts to the remove the entire tumor. If the tumor is too close to important brain tissue, the surgeon may attempt to remove part of the tumor. Removal of the tumor from the brain tissue is called resection. The complete or partial removal of tumor helps to relieve symptoms by reducing pressure on healthy tissues and reduces the amount of tumor that needs to be treated by radiotherapy.
One type of radiotherapy used to treat brain metastases is stereotactic radiosurgery (SRS). SRS uses many focused radiation beams to treat tumors within the brain. Unlike surgery, there is no incision or cut being made. Instead, SRS uses an accurate map of your brain to deliver a precise beam of radiation to the tumors. The radiation damages the tumor cells forcing them to shrink and die off. The focused radiation beams also limit damage to healthy brain tissue minimizing side effects.
Surgery followed by radiotherapy is a standard treatment for brain metastases. However, there are still risks associated with the combination of treatments. This study plans to investigate whether performing surgery prior to SRS results in improved quality of life and decreased side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical Resection followed by SRS (Non-Experimental) | Active comparator | Procedure: Brain Surgery, Radiation: Stereotactic RadiosurgerySurgical Resection followed by SRS within 3 weeks of surgery date. |
| SRS followed by Surgical Resection (Experimental) | Experimental | Procedure: Brain Surgery, Radiation: Stereotactic RadiosurgerySRS followed by surgery within 1 week of radiotherapy end date. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- Pathologically-proven primary malignancy
- ECOG 0-2
- Ability to complete neurocognitive testing without assistance from family or friends.
- Previous SRS to lesions other than the one being resected is allowed
Key exclusion criteria (4 listed)
- Patients who have received prior WBRT, or SRS to the lesion being resected at time of study accrual
- Patients unable to undergo MRI scan (e.g. pacemaker)
- Leptomeningeal disease
- Germ cell tumor, small cell lung cancer or hematological primary malignancy
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 |
|---|---|---|
| Brain SurgerySurgery to remove brain metastases | Procedure or surgery | SRS followed by Surgical Resection (Experimental), Surgical Resection followed by SRS (Non-Experimental) |
| Stereotactic RadiosurgeryAlso: SRSSRS uses many focused radiation beams to treat tumors within the brain | Radiation | SRS followed by Surgical Resection (Experimental), Surgical Resection followed by SRS (Non-Experimental) |
Primary outcome
Local Control
Time frame: This will be assessed at 12 months
To compare local control (in months) of pre-operative versus post-operative SRS
7 secondary outcomes
Local Control
Time frame: This will be assessed at 6 and 24 months.
Distant Brain Recurrence Rate
Time frame: This will be assessed at 6,12 and 24 months.
Leptomeningeal Recurrence Rate
Time frame: This will be assessed at 6,12 and 24 months.
Overall Survival
Time frame: This will be assessed at 6,12 and 24 months.
Hopkins Verbal Learning Test
Time frame: This will be assessed at 3,6,9,12,16 and 24 months.
Controlled Oral Word Association
Time frame: This will be assessed at 3,6,9,12,16 and 24 months.
Trial Making Tests
Time frame: This will be assessed at 3,6,9,12,16 and 24 months.
Results and safety
The study was stopped early (reason given: Insufficient accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Derived from this study: PubMed 36585629Das S, Faruqi S, Nordal R, Starreveld Y, Kelly J, Bowden G, Amanie J, Fairchild A, Lim G, Loewen S, Rowe L, Wallace C, Ghosh S, Patel S. A phase III, multicenter, randomized controlled trial of preoperative versus postoperative stereotactic radiosurgery for patients with surgically resectable brain metastases. BMC Cancer. 2022 Dec 30;22(1):1368. doi: 10.1186/s12885-022-10480-z.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Brain Surgery and Stereotactic Radiosurgery in people with Brain Metastases, run by AHS Cancer Control Alberta 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 4 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: stopped early, as of the sponsor's last update on 18 Jul 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Insufficient accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local Control (time frame: This will be assessed at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04474925, which also lists 1 linked publication.
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 18 Jul 2025.