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Radiation Therapy
Whole Brain Radiotherapy + Stereotactic Radiosurgery for Brain Metastasis
Phase 3
Recruiting
Led By Vinai Gondi
Research Sponsored by NRG Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Distant brain relapse lesions to be treated must measure =< 3.0 cm in maximal extent and total volume of distant brain relapses to be treated must measure < 30 mL on the contrast-enhanced diagnostic magnetic resonance imaging (MRI) brain scan obtained within 21 days prior to randomization
Post gadolinium contrast-enhanced T1-weighted three-dimensional (3D) spoiled gradient (SPGR). Acceptable 3D SPGR sequences include magnetization-prepared 3D gradient recalled echo (GRE) rapid gradient echo (MP-RAGE), turbo field echo (TFE) MRI, BRAVO (brain volume imaging) or 3D fast FE (field echo). The T1-weighted 3D scan should use the smallest possible axial slice thickness, not to exceed 1.5 mm
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is testing whether adding whole brain radiation therapy with hippocampal avoidance (to protect memory) and memantine (to protect thinking) to standard stereotactic radiosurgery (a high dose of radiation only to the small areas of cancer in the brain) is more effective than stereotactic radiosurgery alone in treating patients with cancer that has spread to the brain and come back in other areas of the brain after earlier stereotactic radiosurgery.
Who is the study for?
This trial is for patients with certain cancers (like lung, breast, kidney cancer) that have spread to the brain and returned after initial treatment. Participants must have had their first or second relapse at least 8 weeks post-initial radiosurgery and within 21 days before joining the study. They should be able to undergo MRI scans, swallow pills, and not have severe co-morbidities or a history of specific conditions like multiple sclerosis.Check my eligibility
What is being tested?
The trial tests adding whole brain radiotherapy avoiding the hippocampus plus memantine against stereotactic radiosurgery alone in patients whose cancer has spread to the brain. The goal is to see if this combination better controls cancer growth while preserving memory by protecting a key part of the brain involved in this function.See study design
What are the potential side effects?
Potential side effects include cognitive changes due to radiation exposure, particularly affecting memory if the hippocampus is impacted. Memantine may cause dizziness, headache, constipation or confusion. Whole-brain radiotherapy might lead to hair loss, fatigue or skin irritation on the scalp.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My brain lesions are less than 3.0 cm and total volume is under 30 mL.
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My MRI scan used a specific high-detail technique.
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I am mostly able to care for myself and perform normal activities.
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My brain lesions are less than 3.0 cm and total volume is under 30 mL.
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My brain cancer's return was confirmed by an MRI.
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My cancer is not of a specific, excluded type.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to Neurologic Death
Secondary outcome measures
Brain Metastasis Velocity (BMV) at subsequent relapse
Cognitive Abilities
Health Status
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (salvage SRS, memantine, HA-WBRT)Experimental Treatment5 Interventions
Patients undergo HA-WBRT daily (5 times weekly) for 2 weeks for a total of 10 fractions in the absence of disease progression or unacceptable toxicity. Within 1 week prior to or following HA-WBRT, patients undergo salvage SRS. Prior to HA-WBRT or no later than the 4th treatment, patients also receive memantine PO QD or BID for 24 weeks in the absence of disease progression or unacceptable toxicity.
Group II: Arm II (salvage SRS)Active Control3 Interventions
Patients undergo salvage SRS.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Memantine
2006
Completed Phase 4
~1200
Stereotactic Radiosurgery
2016
Completed Phase 2
~460
Whole-Brain Radiotherapy
2012
Completed Phase 2
~150
Find a Location
Who is running the clinical trial?
NRG OncologyLead Sponsor
231 Previous Clinical Trials
100,502 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,661 Previous Clinical Trials
40,924,094 Total Patients Enrolled
Vinai GondiPrincipal InvestigatorNRG Oncology
2 Previous Clinical Trials
618 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- There are signs of changes or abnormal shape in the lateral ventricles in your brain scan.I have a history of a disease like multiple sclerosis.You have had at least 4 new brain metastases each year since getting initial treatment with SRS.My brain lesions are less than 3.0 cm and total volume is under 30 mL.My MRI scan used a specific high-detail technique.My MRI includes a specific type of brain scan.Women who can have children must have a recent negative pregnancy test before joining the study.I am mostly able to care for myself and perform normal activities.Your kidney function, measured by creatinine clearance, is at least 30 ml/min.You need to have a specific type of MRI scan before receiving any contrast dye.I cannot undergo MRI scans or use gadolinium contrast.My cancer that spread to the brain comes from germ cell tumor, small cell carcinoma, or lymphoma.My brain lesions are less than 3.0 cm and total volume is under 30 mL.My cancer has spread to the lining of my brain and spinal cord.I am not allergic to memantine, do not have uncontrollable seizures, am not using NMDA agonists, and do not abuse alcohol or drugs.I cannot swallow pills.You must have certain MRI scans or tests as part of the study requirements.I am scheduled for chemotherapy and radiation on the same day; I may also receive immunotherapy.My cancer is not of a specific, excluded type.My first or second brain relapse occurred 8 weeks after initial treatment and within the last 21 days.My brain cancer's return was confirmed by an MRI.Your blood urea nitrogen level is not more than 1.5 times the upper limit of normal.You have a serious, ongoing health problem as defined.I have had whole brain radiation therapy before.My cancer has returned in the same area after initial radiation treatment.My cancer diagnosis was confirmed within the last 10 years.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (salvage SRS)
- Group 2: Arm I (salvage SRS, memantine, HA-WBRT)
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.
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.
Does the FDA regulate how questionnaires are given to patients?
"Although it is a Phase 3 trial, there is some data supporting efficacy and multiple rounds of data supporting safety, so our team rates Questionnaire Administration as a 3 on Power's safety scale."
Answered by AI
Are new participants still being accepted for this research project?
"Yes, the trial is still searching for patients. According to clinicaltrials.gov, 350 participants are needed and 39 different locations are being considered."
Answered by AI
At how many different facilities can patients enroll in this trial?
"There are a total of 39 sites conducting this clinical trial; some locations include Warrenville, Miami, and Creve Coeur. It is advised that potential participants select the location nearest to them to reduce travel time and costs."
Answered by AI
How many individuals are being asked to participate in this testing period?
"350 individuals that fit the pre-determined inclusionary criteria are required for this research project. Those interested can inquire about participation at Northwestern Medicine Cancer Center Warrenville or University of Miami Miller School of Medicine-Sylvester Cancer Center."
Answered by AI
Could you please provide a list of all other research studies that have made use of Questionnaire Administration?
"In 1997, Questionnaire Administration was first studied Vanderbilt University Autonomic Dysfunction Center. To date, a total of 353 completed trials have been conducted on this topic. Currently, there are 26 live clinical trials taking place; many of which are based in Warrenville, Florida."
Answered by AI
Who else is applying?
What state do they live in?
Maryland
How old are they?
18 - 65
What site did they apply to?
UM Upper Chesapeake Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
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