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Radiation Therapy

High Dose Radiation vs Whole Brain Radiation 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
Pathologically (histologically or cytologically) proven diagnosis of small cell lung cancer within 5 years of registration. If the original histologic proof of malignancy is greater than 5 years, then pathological (i.e., more recent) confirmation is required (e.g., from a systemic or brain metastasis);
REQUIRED MRI ELEMENTS
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up10 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

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.

Eligible Conditions
  • Brain Metastasis
  • Lung Cancer
  • Small Cell Lung Cancer

Eligibility Criteria

Inclusion Criteria

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

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

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
2016
Completed Phase 2
~460

Find a Location

Who is running the clinical trial?

NRG OncologyLead Sponsor
226 Previous Clinical Trials
99,584 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,492 Previous Clinical Trials
41,267,384 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 Missourif 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?
Met criteria
Did not meet 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 Glendale > Delaware
~71 spots leftby Jul 2025
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