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Testing Proton Craniospinal Radiation Therapy Versus the Usual Radiation Therapy for Leptomeningeal Metastasis, RADIATE-LM Trial
NCT06500481 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06500481
The ClinicalTrials.gov registry entry for NCT06500481 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 115 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 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. 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: NCT06500481 reports 20 study locations spanning 5 distinct geographic areas — top geographies include Florida, Illinois, California. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06500481?
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 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.
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