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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
Must not have
Known history of demyelinating disease such as multiple sclerosis
Contraindication to MR imaging or gadolinium contrast administration during MR imaging
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

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 below
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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 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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of a disease like multiple sclerosis.
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I cannot undergo MRI scans or use gadolinium contrast.
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My cancer that spread to the brain comes from germ cell tumor, small cell carcinoma, or lymphoma.
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My cancer has spread to the lining of my brain and spinal cord.
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I am not allergic to memantine, do not have uncontrollable seizures, am not using NMDA agonists, and do not abuse alcohol or drugs.
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I cannot swallow pills.
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I am scheduled for chemotherapy and radiation on the same day; I may also receive immunotherapy.
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I have had whole brain radiation therapy before.
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My cancer has returned in the same area after initial radiation treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

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 more

Trial 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
~490
Whole-Brain Radiotherapy
2012
Completed Phase 2
~150

Find a Location

Who is running the clinical trial?

NRG OncologyLead Sponsor
232 Previous Clinical Trials
100,399 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,051 Total Patients Enrolled
Vinai GondiPrincipal InvestigatorNRG Oncology
2 Previous Clinical Trials
618 Total Patients Enrolled

Media Library

Stereotactic Radiosurgery (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04588246 — Phase 3
Lung Cancer Research Study Groups: Arm II (salvage SRS), Arm I (salvage SRS, memantine, HA-WBRT)
Lung Cancer Clinical Trial 2023: Stereotactic Radiosurgery Highlights & Side Effects. Trial Name: NCT04588246 — Phase 3
Stereotactic Radiosurgery (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04588246 — Phase 3
~43 spots leftby Jan 2025