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Stereotactic Radiosurgery vs. HA-WBRT + Memantine for Brain Cancer
Phase 3
Recruiting
Research Sponsored by Canadian Cancer Trials Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have a pathological diagnosis (cytological or histological) of a non-hematopoietic malignancy
The largest brain metastasis must measure <2.5 cm in maximal diameter
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4.5 years
Awards & highlights
Study Summary
This trial is testing whether memantine used in combination with HA-WBRT helps to improve mental function (measured by how well patients can remember things) compared to those who receive HA-WBRT alone.
Who is the study for?
This trial is for adults with 5 to 15 brain metastases from non-blood cancers, where the largest tumor is smaller than 2.5 cm. They must be able to undergo specific types of radiosurgery and HA-WBRT at certified centers, complete neurocognitive tests, and use effective contraception if needed. Excluded are pregnant/nursing individuals, those with allergies to gadolinium or memantine, prior cranial radiation therapy recipients, patients with certain brain conditions or liver disease.Check my eligibility
What is being tested?
The study compares Stereotactic Radiosurgery (SRS), a precise one-day radiation treatment targeting tumors while sparing normal brain tissue, against Whole Brain Radiotherapy avoiding the hippocampus (HA-WBRT) plus Memantine which aims to protect memory during whole-brain treatment. The effectiveness in controlling cancer spread within the brain and impact on memory will be assessed.See study design
What are the potential side effects?
Potential side effects include local reactions from radiation like hair loss or scalp irritation; cognitive changes such as memory problems; fatigue; headaches; nausea; and potentially more serious complications related to targeted high-dose radiation exposure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is not related to blood and has been confirmed by a lab test.
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My largest brain tumor is smaller than 2.5 cm.
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I can take care of myself and am up and about more than half of my waking hours.
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I am older than 18 years.
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I have between 5 and 15 brain tumors as shown on a recent MRI.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Neurocognitive progression-free survival
Overall Survival
Secondary outcome measures
Analysis of serum samples for inflammatory biomarker C-reactive protein and brain-derived-neurotrophic factor (BDNF) to elucidate molecular/genomic mechanisms of neurocognitive decline and associated radiographic changes
Collect plasma to evaluate whether detectable somatic mutations in liquid biopsy can enhance prediction of the overall survival and development of new brain metastases.
Collect whole-brain dosimetry in SRS patients to be prospectively correlated with cognitive toxicity, intracranial control and radiation necrosis
+12 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Stereotactic Radiosurgery (SRS)Experimental Treatment1 Intervention
SRS 18-20 or 22Gy in single fraction
Group II: Hippocampal-avoidant (HA-WBRT) plus MemantineExperimental Treatment2 Interventions
WBRT 30Gy in 10 fractions + memantine
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Memantine
2006
Completed Phase 4
~1200
Stereotactic Radiosurgery (SRS)
2012
Completed Phase 2
~240
Find a Location
Who is running the clinical trial?
Canadian Cancer Trials GroupLead Sponsor
124 Previous Clinical Trials
67,247 Total Patients Enrolled
Alliance for Clinical Trials in OncologyOTHER
512 Previous Clinical Trials
217,432 Total Patients Enrolled
NRG OncologyOTHER
231 Previous Clinical Trials
100,646 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had radiation therapy to my brain before.I can complete quality of life surveys in English or French, with or without help.I cannot undergo a brain MRI.I am scheduled for chemotherapy around the time of my radiation treatment.My cancer has spread to the lining of my brain and spinal cord.My brain cancer is near my optic nerve or chiasm.I have over 15 brain tumors as shown in my recent MRI.I am currently taking NMDA antagonist medication.I have been diagnosed with chronic liver disease or cirrhosis.I can start the treatment within 14 days of joining the study.I am using a highly effective method of birth control.I am of childbearing age and do not plan to use birth control.I have had surgery to remove a brain tumor that spread from another part of my body.My cancer is not related to blood and has been confirmed by a lab test.My largest brain tumor is smaller than 2.5 cm.I can take care of myself and am up and about more than half of my waking hours.I am older than 18 years.I have between 5 and 15 brain tumors as shown on a recent MRI.My cancer is a type of germ cell tumor, small cell carcinoma, or lymphoma.
Research Study Groups:
This trial has the following groups:- Group 1: Hippocampal-avoidant (HA-WBRT) plus Memantine
- Group 2: Stereotactic Radiosurgery (SRS)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many study participants are enrolled in this research project?
"In total, 206 individuals that meet the pre-determined requirements need to enroll in this study. These individuals can be based in various locations, such as the AtlantiCare Surgery Center in Egg Harbor Township, New jersey or the BCCA-Vancouver Cancer Centre in Vancouver, British Columbia."
Answered by AI
Are there any historical examples of Stereotactic Radiosurgery (SRS)?
"First appearing in 1997 at Vanderbilt University, SRS has undergone a total of 119 clinical trials. 27 of these trials are ongoing, with a significant portion taking place in Egg Harbor Township, New jersey."
Answered by AI
Are there any positions available in this clinical trial for new patients?
"Yes, the trial is still recruiting patients. It was first posted on May 25th, 2018 and was last edited on April 6th, 2022. The trial is looking for 206 patients total, with 50 locations being used."
Answered by AI
Can you tell me how many places this trial is accessible?
"Currently, this trial is open to patients at the AtlantiCare Surgery Center, the BCCA-Vancouver Cancer Centre, Geisinger Medical Center, and 50 other hospitals."
Answered by AI
What risks are associated with Stereotactic Radiosurgery (SRS)?
"There is both clinical evidence and multiple rounds of data supporting the safety of Stereotactic Radiosurgery (SRS), thus our team rates it a 3."
Answered by AI
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