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RECRUITING Phase 3

Stereotactic Radiosurgery Compared With Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) Plus Memantine for 5 or More Brain Metastases

NCT03550391 · View on ClinicalTrials.gov ↗

Study Summary

Stereotactic radiosurgery (SRS) is a commonly used treatment for brain tumors. It is a one-day (or in some cases two day), out-patient procedure during which a high dose of radiation is delivered to small spots in the brain while excluding the surrounding normal brain. Whole brain radiation therapy with hippocampal avoidance (HA-WBRT) is when radiation therapy is given to the whole brain, while trying to decrease the amount of radiation that is delivered to the area of the hippocampus. The hippocampus is a brain structure that is important for memory. Memantine is a drug that is given to help relieve symptoms that can be caused by WBRT, including problems with memory and other mental symptoms. Health Canada, the regulatory body that oversees the use of drugs in Canada, has not approved the sale or use of memantine in combination with WBRT to treat this kind of cancer, although they have allowed its use in this study.

Conditions Studied

Interventions

  • DRUG Memantine
  • RADIATION Hippocampal-avoidant (HA-WBRT) Radiotherapy
  • PROCEDURE Stereotactic Radiosurgery (SRS)

Study Locations (20)

California

  • City of Hope Corona — Corona
  • City of Hope Comprehensive Cancer Center — Duarte
  • City of Hope at Irvine Lennar — Irvine
  • UC San Diego Moores Cancer Center — La Jolla
  • City of Hope Antelope Valley — Lancaster
  • UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange
  • Kaiser Permanente-Rancho Cordova Cancer Center — Rancho Cordova
  • Rohnert Park Cancer Center — Rohnert Park
  • The Permanente Medical Group-Roseville Radiation Oncology — Roseville
  • South Sacramento Cancer Center — Sacramento
  • Kaiser Permanente Medical Center - Santa Clara — Santa Clara
  • City of Hope South Pasadena — South Pasadena
  • Kaiser Permanente Cancer Treatment Center — South San Francisco
  • City of Hope South Bay — Torrance
  • City of Hope Upland — Upland

Florida

  • Boca Raton Regional Hospital — Boca Raton
  • UM Sylvester Comprehensive Cancer Center at Coral Gables — Coral Gables
  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach — Deerfield Beach

Arizona

  • University of Arizona Cancer Center-Orange Grove Campus — Tucson
  • University of Arizona Cancer Center-North Campus — Tucson

Trial Details

FieldValue
Enrollment Target 206 participants
Start Date 2018-11-22
Est. Completion 2027-12-31
Phase Phase 3

Sponsor

Canadian Cancer Trials Group

102 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03550391

The ClinicalTrials.gov registry entry for NCT03550391 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 206 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Canadian Cancer Trials Group, which has 102 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Brain Metastases appearing as the primary indexed condition, and to 3 interventions — of which Memantine is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03550391 reports 20 study locations spanning 3 distinct geographic areas — top geographies include California, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03550391 about?

NCT03550391 is a clinical study titled "Stereotactic Radiosurgery Compared With Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) Plus Memantine for 5 or More Brain Metastases". Stereotactic radiosurgery (SRS) is a commonly used treatment for brain tumors. It is a one-day (or in some cases two day), out-patient procedure during which a high dose of radiation is delivered to small spots in the brain while excluding the surrounding normal brain. Whole brain radiation therapy...

What is the current status of trial NCT03550391?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 206 participants. The study started on 2018-11-22. Estimated completion is 2027-12-31.

What conditions does trial NCT03550391 study?

This clinical trial studies the following conditions: Brain Metastases. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03550391?

The interventions under investigation include: Memantine (DRUG), Hippocampal-avoidant (HA-WBRT) Radiotherapy (RADIATION), Stereotactic Radiosurgery (SRS) (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03550391?

This trial is sponsored by Canadian Cancer Trials Group, which has 102 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03550391 being conducted?

This trial has 20 study locations across Arizona, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial