Clinical trial NCT04474925: Pre- Versus Post-operative SRS for Resectable Brain Metastases
Official title: A Randomized Controlled Trial of Pre-operative Versus Post-operative Stereotactic Radiosurgery for Patients With Surgically Resectable Brain Metastases
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Brain Metastases
Keywords: Neurosurgery
Stereotactic Radiosurgery
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
First posted: 2020-07-17
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Local Control
timeFrame: This will be assessed at 12 months
Secondary outcomes:
measure: Local Control
timeFrame: This will be assessed at 6 and 24 months.
measure: Distant Brain Recurrence Rate
timeFrame: This will be assessed at 6,12 and 24 months.
measure: Leptomeningeal Recurrence Rate
timeFrame: This will be assessed at 6,12 and 24 months.
measure: Overall Survival
timeFrame: This will be assessed at 6,12 and 24 months.
measure: Hopkins Verbal Learning Test
timeFrame: This will be assessed at 3,6,9,12,16 and 24 months.
measure: Controlled Oral Word Association
timeFrame: This will be assessed at 3,6,9,12,16 and 24 months.
measure: Trial Making Tests
timeFrame: This will be assessed at 3,6,9,12,16 and 24 months.
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre/Arthur J.E. Child Comprehensive Cancer Centre
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
References: