Hippocampal Avoidance in Craniospinal Irradiation for the Treatment of Leptomeningeal Metastases From Breast Cancer or Non-small Cell Lung Cancer

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Washington

About this trial

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.

Eligibility criteria

Qualifiers

Patients with breast cancer or NSCLC malignancies with leptomeningeal metastases established radiographically and/or through CSF cytology

Patients who are candidates for radiation therapy for the treatment of leptomeningeal metastases

Patients ≥ 18 years old

Karnofsky performance status (KPS) ≥ 60 or Eastern Cooperative Oncology Group (ECOG) ≥ 2

Disqualifiers

Patients with multiple, serious major neurologic deficits per physician/investigator assessment including encephalopathy

Patients with extensive systemic disease and without reasonable systemic treatment options

Patients who are unable to undergo MRI brain and spine with gadolinium contrast

Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • Computed Tomography
  • Electronic Health Record Review
  • Lumbar Puncture
  • Magnetic Resonance Imaging
  • Positron Emission Tomography
  • Proton Beam Craniospinal Irradiation
  • Survey Administration
  • Volume Modulated Arc Therapy
  • Hippocampal-Avoidance Craniospinal Irradiation

Treatment groups

22 Participants
are divided into 1 treatment group

Sponsors and collaborators