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Pre- vs Post-operative SRS for Brain Cancer

Phase 3
Recruiting
Research Sponsored by AHS Cancer Control Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ability to complete neurocognitive testing without assistance from family or friends
ECOG 0-2
Must not have
Patients who have received prior WBRT, or SRS to the lesion being resected at time of study accrual
Leptomeningeal disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up this will be assessed at 3,6,9,12,16 and 24 months.
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial will compare how patients do when they have SRS before surgery versus surgery before SRS.

Who is the study for?
This trial is for adults with confirmed primary cancer who have brain metastases. They must be able to perform neurocognitive tests, not have had whole-brain radiotherapy or SRS on the lesion in question, and can't have specific cancers like germ cell tumors or small cell lung cancer.
What is being tested?
The study is testing if performing stereotactic radiosurgery (SRS) before surgery gives better outcomes than doing surgery first for patients with brain metastases. It aims to see which sequence improves quality of life and reduces side effects.
What are the potential side effects?
Potential side effects include tissue damage from radiation leading to headaches, nausea, hair loss at treatment site, fatigue, swelling and possible short-term worsening of neurological symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can complete brain function tests on my own.
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I can take care of myself and am up and about more than half of the day.
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I am 18 years old or older.
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My cancer diagnosis was confirmed through a biopsy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had whole brain radiation or stereotactic radiosurgery on the tumor being removed.
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My cancer has spread to the lining of my brain and spinal cord.
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My cancer is either a germ cell tumor, small cell lung cancer, or a blood-related cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~this will be assessed at 3,6,9,12,16 and 24 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and this will be assessed at 3,6,9,12,16 and 24 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Controlled Oral Word Association
Distant Brain Recurrence Rate
Hopkins Verbal Learning Test
+4 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: SRS followed by Surgical Resection (Experimental)Experimental Treatment2 Interventions
SRS followed by surgery within 1 week of radiotherapy end date.
Group II: Surgical Resection followed by SRS (Non-Experimental)Active Control2 Interventions
Surgical Resection followed by SRS within 3 weeks of surgery date.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Radiosurgery
2021
Completed Phase 2
~440

Find a Location

Who is running the clinical trial?

AHS Cancer Control AlbertaLead Sponsor
182 Previous Clinical Trials
26,743 Total Patients Enrolled

Media Library

Brain Surgery Clinical Trial Eligibility Overview. Trial Name: NCT04474925 — Phase 3
Brain Tumor Research Study Groups: Surgical Resection followed by SRS (Non-Experimental), SRS followed by Surgical Resection (Experimental)
Brain Surgery 2023 Treatment Timeline for Medical Study. Trial Name: NCT04474925 — Phase 3
Brain Tumor Clinical Trial 2023: Brain Surgery Highlights & Side Effects. Trial Name: NCT04474925 — Phase 3
~17 spots leftby Sep 2025
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