← Back to Search

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
My small cell lung cancer has spread to my brain.
Select...
I have 10 or fewer small brain tumors, not near the memory center, confirmed by a recent MRI.
Select...
I am 18 years old or older.
Select...
My tumor is smaller than 30 cubic centimeters.
Select...
My brain cancer was confirmed by an MRI with detailed requirements.
Select...
I have brain metastases that cause symptoms or are in critical brain areas.
Select...
My lung cancer is either new or has come back.
Select...
I am able to care for myself but may not be able to do active work.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to Neurocognitive Failure
Secondary outcome measures
Incidence of adverse events
Overall Survival
Perceived Difficulties in Cognition
+4 more
Other outcome measures
Time delay to salvage WBRT or HA-WBRT in patients on the SRS arm
Time to incidence of distant brain relapses
Time to leptomeningeal dissemination
+1 more

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
2016
Completed Phase 2
~460

Find a Location

Who is running the clinical trial?

NRG OncologyLead Sponsor
231 Previous Clinical Trials
100,652 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,347 Total Patients Enrolled
Vinai GondiPrincipal InvestigatorNRG Oncology
2 Previous Clinical Trials
768 Total Patients Enrolled

Media Library

Stereotactic Radiosurgery (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04804644 — Phase 3
Brain Metastasis Research Study Groups: Arm I (SRS), Arm II (HA-WBRT, memantine)
Brain Metastasis Clinical Trial 2023: Stereotactic Radiosurgery Highlights & Side Effects. Trial Name: NCT04804644 — Phase 3
Stereotactic Radiosurgery (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04804644 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are other examples of research using Stereotactic Radiosurgery?

"First observed in 1997 at Vanderbilt University's Autonomic Dysfunction Center, Stereotactic Radiosurgery has been the focus of 122 clinical trials. Out of these, 27 are still active. Maryland's Easton location has a high concentration of these ongoing studies."

Answered by AI

Has Stereotactic Radiosurgery been cleared by the FDA?

"There is some efficacy data and multiple rounds of safety data, so our team has rated the safety of Stereotactic Radiosurgery as a 3."

Answered by AI

Are we currently enrolling patients for this experiment?

"Yes, this information is accurate. The trial was posted on 24 March 2021 and was updated on 8 April 2022."

Answered by AI

How many individuals are being monitored for this research?

"That is correct. The clinical trial is recruiting at 82 locations and is looking for a total of 200 participants. The original posting was on 2021-03-24, with the most recent update on 2022-04-08."

Answered by AI

Do a lot of hospitals in Canada offer this treatment?

"So far, 82 patients have enrolled at this clinical trial's various locations, which include the University of Maryland Shore Medical Center at Easton in Easton, Saint Mary Mercy Hospital in Livonia, and Missouri Baptist Outpatient Center-Sunset Hills in Sunset Hills."

Answered by AI

Who else is applying?

What state do they live in?
Maryland
California
Pennsylvania
What site did they apply to?
Anne Arundel Medical Center
Los Angeles County-USC Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
Recent research and studies
clinicaltrials.govStudy
Testing if High Dose Radiation Only to the Sites of Brain Cancer Compared to Whole Brain Radiation That Avoids the Hippocampus is Better at Preventing Loss of Memory and Thinking Ability
2021. "Testing if High Dose Radiation Only to the Sites of Brain Cancer Compared to Whole Brain Radiation That Avoids the Hippocampus is Better at Preventing Loss of Memory and Thinking Ability". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04804644.
All > Lung Cancer Boston > Brain Cancer
~115 spots leftby Jul 2028
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top