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 (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 radioa

Trial Details

NCT ID
NCT06500481
Phase
PHASE3
Sponsor
NRG Oncology
Status
RECRUITING
Cancer Type
Non-Small Cell (NSCLC) Lung Cancer
Interventions
  • Biospecimen Collection
  • Computed Tomography
  • Involved-Field Radiation Therapy
  • Lumbar Puncture
  • Magnetic Resonance Imaging
  • Positron Emission Tomography
Locations (sample)
  • Phoenix, Arizona, United States|33.44838,-112.07404
  • Little Rock, Arkansas, United States|34.74648,-92.28959
  • Encinitas, California, United States|33.03699,-117.29198
  • La Jolla, California, United States|32.84727,-117.2742
  • San Diego, California, United States|32.71571,-117.16472

Key Eligibility Criteria

  • PRIOR TO STEP 1 REGISTRATION
  • Patients with pathologically (histologically or cytologically) proven diagnosis of breast cancer or NSCLC
  • Patients must have newly diagnosed leptomeningeal metastasis established through at least one of the following:
  • Positive CSF cytology for malignancy

For full eligibility, visit ClinicalTrials.gov.

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