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NCT04804644 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Stage IV Lung Cancer AJCC v8 and Metastatic Malignant Neoplasm in the Brain, sponsored by NRG Oncology.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 200
- Enrollment target
- 20
- Study locations
NCT04804644: Recruiting Phase 3 study of Stage IV Lung Cancer AJCC v8 and Metastatic Malignant Neoplasm in the Brain, sponsored by NRG Oncology.
NCT04804644 is a Phase 3 study of Stage IV Lung Cancer AJCC v8 and Metastatic Malignant Neoplasm in the Brain that is actively recruiting participants, run by NRG Oncology. The registered enrollment target is 200 participants, above the 96-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (108% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04804644, a Phase 3 study of Stage IV Lung Cancer AJCC v8 and Metastatic Malignant Neoplasm in the Brain, is actively recruiting participants, sponsored by NRG Oncology.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 200 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
A failure is defined using the reliable change index (RCI) criteria, as measured by the Hopkins Verbal Learning Test - Revised (HVLT-R), Controlled Oral Word Association (COWA) test, and Trail Making Test (TMT) Parts A and B. The cumulative incidence approach will be used to estimate the percentage of failures while accounting for the competing risk of death.
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 |
What NCT04804644 shows while recruiting
NCT04804644 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, above the 96-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (108% higher).
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.
NCT04804644 names 20 study sites across 5 states, led by California, Connecticut, Delaware.
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.
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).
Who is sponsoring clinical trial NCT04804644?
This trial is sponsored by NRG Oncology, which has 64 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04804644's enrollment target sits among peer trials
200 11th of 81 higher than 71 of 81 other Stage IV Lung Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage IV Lung Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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