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NCT06500481 · ClinicalTrials.gov registry record · Phase 3
Testing Proton Craniospinal Radiation Therapy Versus the Usual Radiation Therapy for Leptomeningeal Metastasis, RADIATE-LM Trial
A Phase 3 study of Stage IV Lung Cancer AJCC v8 and Anatomic Stage IV Breast Cancer AJCC v8, sponsored by NRG Oncology.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 115
- Enrollment target
- 20
- Study locations
NCT06500481: Recruiting Phase 3 study of Stage IV Lung Cancer AJCC v8 and Anatomic Stage IV Breast Cancer AJCC v8, sponsored by NRG Oncology.
NCT06500481 is a Phase 3 study of Stage IV Lung Cancer AJCC v8 and Anatomic Stage IV Breast Cancer AJCC v8 that is actively recruiting participants, run by NRG Oncology. The registered enrollment target is 115 participants, above the 97-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (19% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06500481, a Phase 3 study of Stage IV Lung Cancer AJCC v8 and Anatomic Stage IV Breast Cancer AJCC v8, is actively recruiting participants, sponsored by NRG Oncology.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 115 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase III trial compares proton craniospinal irradiation (pCSI) to involved-field radiation therapy (IFRT) for the treatment of breast or non-small cell lung cancer that has spread from where it first started to the cerebrospinal fluid filled space that surrounds the brain and spinal cord (leptomeningeal metastasis). Patients with leptomeningeal metastasis (LM) may develop multiple areas of nervous system (neurologic) impairment that can be life-threatening. Radiation therapy (RT) effectively relieves local symptoms due to LM. RT uses high energy radiography (x-rays), particles, or radioactive seeds to kill cancer cells and shrink tumors. IFRT is commonly used to treat symptoms of LM. IFRT is radiation treatment that uses x-rays to treat specific areas of LM and to relieve and/or prevent symptoms. pCSI uses protons that can be directed with more accuracy than x-rays which allows treatment of the entire central nervous system space containing the cerebrospinal fluid (CSF), brain, and spinal cord. The pCSI treatment could delay the worsening of LM. Giving pCSI may be better than IFRT in treating LM in patients with breast or non-small cell lung cancer.
Primary Outcome
Will be event-driven and will be conducted when a total of 88 OS events (from both treatment arms) have been observed. The final analysis (if the trial does not stop early at an interim) is expected to occur roughly 45 months after study activation (including the initial 6-months ramp-up). All analyses (interim or final) will be done on a modified intent-to-treat (ITT) basis such that all randomized patients who have follow-up information will be included in the arm to which they are randomized
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Lumbar Puncture
- PROCEDURE Magnetic Resonance Imaging
- RADIATION Involved-Field Radiation Therapy
Study Locations (20)
Florida
- UM Sylvester Comprehensive Cancer Center at Aventura - Aventura
- UM Sylvester Comprehensive Cancer Center at Coral Gables - Coral Gables
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach - Deerfield Beach
- UM Sylvester Comprehensive Cancer Center at Doral - Doral
- University of Miami Miller School of Medicine-Sylvester Cancer Center - Miami
- Miami Cancer Institute - Miami
- UM Sylvester Comprehensive Cancer Center at Kendall - Miami
- UM Sylvester Comprehensive Cancer Center at Plantation - Plantation
Illinois
- Alton Memorial Hospital - Alton
- Northwestern University - Chicago
- Northwestern Medicine Cancer Center Kishwaukee - DeKalb
- Northwestern Medicine Cancer Center Delnor - Geneva
- Memorial Hospital East - Shiloh
- Northwestern Medicine Cancer Center Warrenville - Warrenville
California
- UC San Diego Health System - Encinitas - Encinitas
- UC San Diego Moores Cancer Center - La Jolla
- UC San Diego Medical Center - Hillcrest - San Diego
- California Protons Cancer Therapy Center - San Diego
Arkansas
- University of Arkansas for Medical Sciences - Little Rock
District of Columbia
- Sibley Memorial Hospital - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 115 participants |
| Start Date | 2025-03-04 |
| Est. Completion | 2028-07-31 |
| Phase | Phase 3 |
What NCT06500481 shows while recruiting
NCT06500481 is an interventional study that assigns participants to a tested intervention. The registered 115 participants enrollment target is mid-sized for trials with a published cap, above the 97-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (19% higher).
The record links to 5 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.
NCT06500481 names 20 study sites across 5 states, led by Florida, Illinois, California.
Frequently Asked Questions
What is clinical trial NCT06500481 about?
NCT06500481 is a clinical study titled "Testing Proton Craniospinal Radiation Therapy Versus the Usual Radiation Therapy for Leptomeningeal Metastasis, RADIATE-LM Trial". This phase III trial compares proton craniospinal irradiation (pCSI) to involved-field radiation therapy (IFRT) for the treatment of breast or non-small cell lung cancer that has spread from where it first started to the cerebrospinal fluid filled space that surrounds the brain and spinal cord (lept...
What is the current status of trial NCT06500481?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 115 participants. The study started on 2025-03-04. Estimated completion is 2028-07-31.
What conditions does trial NCT06500481 study?
This clinical trial studies the following conditions: Stage IV Lung Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Lung Non-Small Cell Carcinoma, Metastatic Breast Carcinoma, Metastatic Malignant Neoplasm in the Leptomeninges.
What interventions are being tested in trial NCT06500481?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Lumbar Puncture (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Involved-Field Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT06500481?
This trial is sponsored by NRG Oncology, which has 64 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06500481 being conducted?
This trial has 20 study locations across Arkansas, California, District of Columbia, Florida, Illinois. 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 NCT06500481's enrollment target sits among peer trials
115 17th of 81 higher than 65 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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