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Radiation Therapy

Whole Brain Radiotherapy + Stereotactic Radiosurgery for Brain Metastasis

Phase 3

Waitlist Available

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

No Placebo-Only Group

Pivotal Trial

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to Neurologic Death

Secondary study objectives

Brain Metastasis Velocity (BMV) at subsequent relapse

Cognitive Abilities

Health Status

+4 more

Awards & Highlights

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.

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

2021