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Study identifier: NCT06500481 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Testing Proton Craniospinal Radiation Therapy Versus the Usual Radiation Therapy for Leptomeningeal Metastasis, RADIATE-LM Trial

Condition: Anatomic Stage IV Breast Cancer AJCC v8 · Metastatic Breast Carcinoma · Metastatic Lung Non-Small Cell Carcinoma  ·  Sponsor: NRG Oncology

PhasePhase 3
Planned participants115
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Contact details are listed per location below or on the registry record.

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Locations (58)

Mayo Clinic Hospital in ArizonaPhoenix, Arizona, United StatesRecruiting
University of Arkansas for Medical SciencesLittle Rock, Arkansas, United StatesRecruiting
UC San Diego Health System - EncinitasEncinitas, California, United StatesRecruiting
UC San Diego Moores Cancer CenterLa Jolla, California, United StatesRecruiting
UC San Diego Medical Center - HillcrestSan Diego, California, United StatesRecruiting
California Protons Cancer Therapy CenterSan Diego, California, United StatesRecruiting
Sibley Memorial HospitalWashington D.C., District of Columbia, United StatesRecruiting
UM Sylvester Comprehensive Cancer Center at AventuraAventura, Florida, United StatesRecruiting
UM Sylvester Comprehensive Cancer Center at Coral GablesCoral Gables, Florida, United StatesRecruiting
UM Sylvester Comprehensive Cancer Center at Deerfield BeachDeerfield Beach, Florida, United StatesRecruiting
UM Sylvester Comprehensive Cancer Center at DoralDoral, Florida, United StatesRecruiting
University of Miami Miller School of Medicine-Sylvester Cancer CenterMiami, Florida, United StatesRecruiting

+ 46 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06500481