About this trial
This phase II trial tests how well craniospinal irradiation (CSI) using photon volumetric modulated arc radiotherapy (VMAT) works in treating patients with breast cancer or non-small cell lung cancer (NSCLC) that has spread from the original (primary) tumor to the cerebrospinal fluid and meninges (thin layers of tissue that cover and protect the brain and spinal cord) (leptomeningeal disease). Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. CSI (radiation therapy directed at the brain and spinal cord to kill tumor cells) may be able to target all of the areas of possible leptomeningeal tumor spread. Photon-VMAT-CSI may be an effective treatment option for patients with leptomeningeal disease secondary to breast cancer or NSCLC.
Eligibility criteria
Qualifiers
Documented informed consent of the participant and/or legally authorized representative
Assent, when appropriate, will be obtained per institutional guidelines
≥ 18 years
Karnofsky performance status (KPS) ≥ 60
Disqualifiers
Chemotherapy, biological therapy, immunotherapy within 7 days prior to day 1 of protocol therapy
Any prior radiation that in the opinion of the investigator unable to respect normal tissue tolerances and preclude craniospinal irradiation
Patients with multiple or serious major neurologic symptoms (including encephalopathy) per physician / investigator assessment
Patients with extensive, uncontrolled extracranial systemic disease
Trial design
Treatments tested in this trial
- Biospecimen Collection
- Craniospinal Irradiation
- Electronic Health Record Review
- Lumbar Puncture
- Magnetic Resonance Imaging
- Ommaya Reservoir Tap
- Questionnaire Administration
- Volume Modulated Arc Therapy
Treatment groups
Locations
2Sponsors and collaborators
City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator