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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 belowSelect...
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:Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ this will be assessed at 3,6,9,12,16 and 24 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~this will be assessed at 3,6,9,12,16 and 24 months.
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 moreAwards & 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
26,626 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had radiation therapy on cancer spots other than the one being removed.Women who could become pregnant must have a negative pregnancy test within a week before joining the study.I can complete brain function tests on my own.I can make my own medical decisions or have someone who can.I have had whole brain radiation or stereotactic radiosurgery on the tumor being removed.You cannot have an MRI scan because you have a pacemaker.My cancer has spread to the lining of my brain and spinal cord.My cancer is either a germ cell tumor, small cell lung cancer, or a blood-related cancer.I can take care of myself and am up and about more than half of the day.I am 18 years old or older.My cancer diagnosis was confirmed through a biopsy.
Research Study Groups:
This trial has the following groups:- Group 1: Surgical Resection followed by SRS (Non-Experimental)
- Group 2: SRS followed by Surgical Resection (Experimental)
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Awards:
This trial has 2 awards, including:- 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.