At a glance
ClinicalIndex Comparison Record- ✓Breast cancer or NSCLC with leptomeningeal metastases confirmed by imaging and/or CSF cytology
- ✓Candidate for radiation therapy for leptomeningeal metastases
- ✓Age ≥18 years
- ✓Able to provide informed consent
- ✕Multiple serious major neurologic deficits including encephalopathy per physician assessment
- ✕Extensive systemic disease without reasonable systemic treatment options
- ✕Unable to undergo MRI brain and spine with gadolinium contrast
- ✕Previous radiotherapy to intended treatment site precluding treatment plan within normal tissue tolerances
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-Center Phase 2 Study of Hippocampal Avoidance in Craniospinal Irradiation for Leptomeningeal Metastases From Solid Tumors
In Brief
A Phase 2 clinical trial evaluating Biospecimen Collection, Computed Tomography, and 8 other interventions for Anatomic Stage IV Breast Cancer AJCC v8 and 4 related conditions. Currently recruiting, targeting 22 participants across 2 sites.
Detailed Summary
This phase II clinical trial studies how well craniospinal irradiation (CSI) with hippocampal avoidance, using proton therapy or volumetric modulated arc therapy (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 (CSF) and meninges (thin layers of tissue that cover and protect the brain and spinal cord) (leptomeningeal metastases). Radiation therapy is an effective treatment in relieving localized symptoms caused by leptomeningeal metastases. However, the type of radiation therapy typically used does not prevent the spread of leptomeningeal disease. 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. CSI may however result in significant neurological side effects due to radiation damage to a part of the brain called the hippocampus. Hippocampal avoidance (HA) reduces the amount of radiation to the hippocampus. Proton or VMAT CSI with HA may be an effective treatment while reducing neurological side effects for patients with leptomeningeal metastases from breast cancer and NSCLC.
Study Details
Timeline
Arms & Interventions
Patients undergo proton or photon VMAT CSI with HA over approximately 45 minutes once daily (QD) for 10 days (Monday-Friday) in the absence of unacceptable toxicity. Patients also undergo computed tomography (CT) or positron emission tomography (PET)/CT during screening. Additionally, patients undergo additional CT for radiation planning during screening and magnetic resonance imaging (MRI) throughout the trial. Patients may also undergo lumbar puncture (LP) or alternative methods for cerebral spinal fluid (CSF) collection at the discretion of the treating physician and principal investigator throughout the study.
Interventions
Undergo CSF sample collection
Undergo PET/CT and/or CT
Ancillary studies
Undergo lumbar puncture
Undergo MRI
Undergo PET/CT
Undergo proton CSI
Ancillary studies
Undergo photon VMAT CSI
Undergo HA