Pre- Versus Post-operative SRS for Resectable Brain Metastases

Brain Metastases Clinical Trial

Official title:

A Randomized Controlled Trial of Pre-operative Versus Post-operative Stereotactic Radiosurgery for Patients With Surgically Resectable Brain Metastases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04474925
• Other study ID #: IIT-0010
• Status: Recruiting
• Phase: Phase 3
• Start date: September 27, 2021
• Est. completion date: August 1, 2026

Study information

• Verified date: October 2023
• Source: AHS Cancer Control Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: August 1, 2026
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Neoplasm Metastasis

Intervention

Procedure:
• Brain Surgery
Surgery to remove brain metastases

Radiation:
• Stereotactic Radiosurgery
SRS uses many focused radiation beams to treat tumors within the brain

Locations

Country	Name	City	State
Canada	Tom Baker Cancer Centre	Calgary	Alberta
Canada	Cross Cancer Institute	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
AHS Cancer Control Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local Control	To compare local control (in months) of pre-operative versus post-operative SRS	This will be assessed at 12 months
Secondary	Local Control	To compare local control (in months) of pre-operative versus post-operative SRS	This will be assessed at 6 and 24 months.
Secondary	Distant Brain Recurrence Rate	To compare Distant Brain Recurrence Rate (%) of pre-operative versus post-operative SRS	This will be assessed at 6,12 and 24 months.
Secondary	Leptomeningeal Recurrence Rate	To compare the Leptomeningeal Recurrence Rate (%) of pre-operative versus post-operative SRS	This will be assessed at 6,12 and 24 months.
Secondary	Overall Survival	Overall survival will be compared between both treatment arms	This will be assessed at 6,12 and 24 months.
Secondary	Hopkins Verbal Learning Test	Participants are scored using a points based system on Total Recall, Delayed Recall, Retention (% retained), and a Recognition Discrimination Index.	This will be assessed at 3,6,9,12,16 and 24 months.
Secondary	Controlled Oral Word Association	Participants are scored on their ability to generate words starting with a specific letter in a one minute timeframe.	This will be assessed at 3,6,9,12,16 and 24 months.
Secondary	Trial Making Tests	Participants are scored on their ability to complete the test within a certain timeframe.	This will be assessed at 3,6,9,12,16 and 24 months.