About this 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 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.

Eligibility criteria

Qualifiers

PRIOR TO STEP 1 REGISTRATION

Patients with pathologically (histologically or cytologically) proven diagnosis of breast cancer or NSCLC

Positive CSF cytology for malignancy

CSF cytology with suspicious cells is considered positive; CSF cytology with atypical cells is considered equivocal and not positive

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • Computed Tomography
  • Involved-Field Radiation Therapy
  • Lumbar Puncture
  • Magnetic Resonance Imaging
  • Positron Emission Tomography
  • Proton Beam Craniospinal Irradiation
  • Quality-of-Life Assessment

Treatment groups

115 Participants
are divided into 2 treatment groups

Locations

58
Arizona
Mayo Clinic Hospital in Arizona85054, Phoenix United States
Arkansas
University of Arkansas for Medical Sciences72205, Little Rock United States
California
UC San Diego Health System - Encinitas92024, Encinitas United States
UC San Diego Moores Cancer Center92093, La Jolla United States

Sponsors and collaborators

NRG Oncology

Lead sponsor