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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
NCT04804644 · View on ClinicalTrials.gov ↗
Study Summary
This phase III trial compares the effect of stereotactic radiosurgery to standard of care memantine and whole brain radiation therapy that avoids the hippocampus (the memory zone of the brain) for the treatment of small cell lung cancer that has spread to the brain. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. Whole brain radiation therapy delivers a low dose of radiation to the entire brain including the normal brain tissue. Hippocampal avoidance during whole-brain radiation therapy (HA-WBRT) decreases the amount of radiation that is delivered to the hippocampus which is a brain structure that is important for memory. The drug, memantine, is also often given with whole brain radiotherapy because it may decrease the risk of side effects related to thinking and memory. Stereotactic radiosurgery may decrease side effects related to memory and thinking compared to standard of care HA-WBRT plus memantine.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Magnetic Resonance Imaging
- RADIATION Stereotactic Radiosurgery
- OTHER Neurocognitive Assessment
- DRUG Memantine Hydrochloride
Study Locations (20)
California
- Kaiser Permanente-Anaheim — Anaheim
- Kaiser Permanente-Bellflower — Bellflower
- Kaiser Permanente Los Angeles Medical Center — Los Angeles
- Los Angeles General Medical Center — Los Angeles
- USC / Norris Comprehensive Cancer Center — Los Angeles
- Kaiser Permanente-Ontario — Ontario
Connecticut
- Smilow Cancer Hospital Care Center at Greenwich — Greenwich
- Smilow Cancer Hospital Care Center - Guilford — Guilford
- Smilow Cancer Center/Yale-New Haven Hospital — New Haven
- Yale University — New Haven
- Smilow Cancer Hospital Care Center-Trumbull — Trumbull
- Smilow Cancer Hospital Care Center - Waterford — Waterford
Delaware
- Beebe Medical Center — Lewes
- Delaware Clinical and Laboratory Physicians PA — Newark
- Helen F Graham Cancer Center — Newark
- Medical Oncology Hematology Consultants PA — Newark
Colorado
- UCHealth University of Colorado Hospital — Aurora
- UCHealth Memorial Hospital Central — Colorado Springs
- Memorial Hospital North — Colorado Springs
Arizona
- Mayo Clinic Hospital in Arizona — Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2021-06-10 |
| Est. Completion | 2030-07-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04804644
The ClinicalTrials.gov registry entry for NCT04804644 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 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NRG Oncology, which has 162 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Stage IV Lung Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions — of which Biospecimen Collection 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: NCT04804644 reports 20 study locations spanning 5 distinct geographic areas — top geographies include California, Connecticut, Delaware. 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 NCT04804644 about?
NCT04804644 is a clinical study titled "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". This phase III trial compares the effect of stereotactic radiosurgery to standard of care memantine and whole brain radiation therapy that avoids the hippocampus (the memory zone of the brain) for the treatment of small cell lung cancer that has spread to the brain. Stereotactic radiosurgery is a sp...
What is the current status of trial NCT04804644?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 200 participants. The study started on 2021-06-10. Estimated completion is 2030-07-01.
What conditions does trial NCT04804644 study?
This clinical trial studies the following conditions: Stage IV Lung Cancer AJCC v8, Metastatic Malignant Neoplasm in the Brain, Metastatic Lung Small Cell Carcinoma, Recurrent Lung Small Cell Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04804644?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Stereotactic Radiosurgery (RADIATION), Neurocognitive Assessment (OTHER), Memantine Hydrochloride (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04804644?
This trial is sponsored by NRG Oncology, which has 162 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04804644 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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