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Radiation Therapy

Stereotactic Radiosurgery vs Whole-Brain Radiotherapy for Brain Metastasis from Lung Cancer

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

Brain metastases can be diagnosed synchronous to the initial diagnosis of small cell lung cancer or metachronous to the initial diagnosis and management of small cell lung cancer.

Ten or fewer brain metastases ≤ 3 cm in largest diameter and outside a 5-mm margin around either hippocampus must be visible on contrast-enhanced MRI performed ≤ 21 days prior to study entry

Must not have

Definitive leptomeningeal metastases

History of active malignancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial compares the effect of stereotactic radiosurgery to standard of care memantine and whole brain radiation therapy that avoids the hippocampus for the treatment of small cell lung cancer that has spread to the brain.

Who is the study for?

Adults with small cell lung cancer that has spread to the brain, who have not had prior brain radiotherapy or certain other cancers in the last 5 years. Participants must be able to undergo MRI scans, have a good performance status (able to carry out daily activities), and can't be pregnant. They should also not have severe medical conditions or history of allergic reactions to memantine.

What is being tested?

The trial is testing if stereotactic radiosurgery, which targets only tumor sites in the brain, is more effective at preserving memory and thinking than whole-brain radiation therapy avoiding the hippocampus combined with memantine hydrochloride.

What are the potential side effects?

Potential side effects include headaches, nausea, fatigue from radiation treatments; for memantine specifically - dizziness, confusion or constipation may occur. Side effects vary based on individual patient health and treatment specifics.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My small cell lung cancer has spread to my brain.

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I have 10 or fewer small brain tumors, not near the memory center, confirmed by a recent MRI.

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I am 18 years old or older.

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My tumor is smaller than 30 cubic centimeters.

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My brain cancer was confirmed by an MRI with detailed requirements.

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I have brain metastases that cause symptoms or are in critical brain areas.

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My lung cancer is either new or has come back.

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I am able to care for myself but may not be able to do active work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread to the lining of my brain and spinal cord.

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I have a history of cancer.

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I am currently taking medications like amantadine, ketamine, or dextromethorphan.

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I still have seizures despite taking my seizure medication.

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My brain scans show changes due to fluid buildup or other reasons that have altered the shape of my hippocampus.

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I am scheduled for chemotherapy and radiation on the same day.

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I have had radiation therapy to my brain.

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I have a history of a disease like multiple sclerosis.

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I have had a condition where my lymphocytes multiply unusually.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 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 Neurocognitive Failure

Secondary study objectives

Incidence of adverse events

Overall Survival

Perceived Difficulties in Cognition

+4 more

Other study objectives

Time delay to salvage WBRT or HA-WBRT in patients on the SRS arm

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 (SRS)Experimental Treatment2 Interventions

Patients undergo SRS over 1 day (in some cases several days).

Group II: Arm II (HA-WBRT, memantine)Active Control3 Interventions

Patients also undergo HA-WBRT QD for 2 weeks in the absence of disease progression or unacceptable toxicity. Patients will also receive memantine PO QD or BID for up to 24 weeks in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Stereotactic Radiosurgery

2021

Completed Phase 2

~440

0 / 17Eligibility criteria met