Proton Craniospinal Radiation for Cancer in the Brain and Spinal Cord
Trial Summary
What is the purpose of 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.
Research Team
Jonathan T Yang
Principal Investigator
NRG
Eligibility Criteria
This trial is for adults with breast cancer or non-small cell lung cancer that has spread to the fluid around the brain and spinal cord. Participants must have a confirmed diagnosis, positive cerebrospinal fluid (CSF) cytology for malignancy, and be suitable candidates for radiation therapy.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients undergo either involved-field radiation therapy (IFRT) or proton craniospinal irradiation (pCSI) 5 days a week for a total of 10 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term Follow-up
Participants continue to be monitored for overall survival and other outcomes
Treatment Details
Interventions
- Involved-Field Radiation Therapy
- Proton Beam Craniospinal Irradiation
Find a Clinic Near You
Who Is Running the Clinical Trial?
NRG Oncology
Lead Sponsor
National Cancer Institute (NCI)
Collaborator