Hippocampal Avoidance in Craniospinal Irradiation for the Treatment of Leptomeningeal Metastases From Breast Cancer or Non-small Cell Lung Cancer
Recruiting · NCT06518057 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Washington
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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
- The patient is able to provide informed consent
- Hemoglobin \> 8 g/dL
- Absolute neutrophil count \> 1,000/mm
- Platelet count \> 100,000/mm
- Participants born female at birth must either be of non-reproductive potential (i.e. post-menopausal by history \[≥ 60 years old, or with no menses for \> 1 year without an alternative medical cause\], OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum /urine pregnancy test within 3 weeks prior to starting radiation therapy (RT)
- Patients with reproductive potential must agree to practice two highly effective contraceptive methods
Exclusion criteria
- 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
- Gross ventricular disease
- Brain metastases within 5 mm of the hippocampal contours not previously treated
- Pregnant or lactating women
Where it is running
6 locations listed across 3 US states.
- University of California San Francisco - San Francisco, California, United States
- University of California San Francisco - San Francisco, California, United States
- Laura and Isaac Perlmutter Cancer Center at NYU Langone - New York, New York, United States
- Laura and Isaac Perlmutter Cancer Center at NYU Langone - New York, New York, United States
- Fred Hutch/University of Washington Cancer Consortium - Seattle, Washington, United States
- Fred Hutch/University of Washington Cancer Consortium - Seattle, Washington, United States