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

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Completion pushed from Jul 31, 2028 to Jul 31, 2033v10
  2. Site details revised at 2 of 58 sitesv9
  3. Site details revised at 1 of 58 sitesv8
  4. Study sites: 57 to 58v7
  5. Study sites: 56 to 57v6
Show 4 earlier versionsHide 4 earlier versions
  1. Start date: Nov 21, 2024 to Mar 4, 2025 Study sites: 8 to 56 · Completion date: Jul 31, 2033 to Jul 31, 2028 · Eligibility criteria expanded, about 2 words · 1 morev5 Show 4 more changesShow less
    • Study sites: 8 to 56
    • Completion date: Jul 31, 2033 to Jul 31, 2028
    • Eligibility criteria expanded, about 2 words
    • Collaborators shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 8 · Start date changed from estimate of Aug 18, 2025 to Nov 21, 2024v4 Show 2 more changesShow less
    • Study sites: 0 to 8
    • Start date changed from estimate of Aug 18, 2025 to Nov 21, 2024
  3. Start date: Nov 30, 2024 to Aug 18, 2025v3
  4. Start date: Sep 11, 2024 to Nov 30, 2024v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06500481
Lead Sponsor NRG Oncology
Conditions Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Metastatic Lung Non-Small Cell Carcinoma, Metastatic Malignant Neoplasm in the Leptomeninges, Stage IV Lung Cancer AJCC v8
Enrollment 115 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov