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Hippocampal Avoidance in Craniospinal Irradiation for the Treatment of Leptomeningeal Metastases from Breast Cancer or Non-small Cell Lung Cancer
Trial Status: active
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.
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 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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06518057.
Locations matching your search criteria
United States
New York
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Fred Hutch/University of Washington/Seattle Children's Cancer Consortium
Status: Active
Contact: Lia Moriguchi Halasz
Phone: 206-598-4100
PRIMARY OBJECTIVE:
I. To evaluate central nervous system (CNS) progression free survival (CNS-PFS) with hippocampal avoidance in CSI for leptomeningeal metastases (LM) from breast cancer and NSCLC.
SECONDARY OBJECTIVES:
I. To evaluate adverse events associated with hippocampal avoidance CSI (HA-CSI).
II. To evaluate neurocognitive function prospectively in patients receiving CSI.
III. To evaluate overall survival (OS).
EXPLORATORY OBJECTIVE:
I. To compare endpoints between the proton and photon groups.
OUTLINE:
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.
After completion of study treatment, patients are followed up at 3, 6, 9, and 12 months, and then at the time of CNS disease progression, up to 1 year.
Trial PhasePhase II
Trial Typetreatment
Lead OrganizationFred Hutch/University of Washington/Seattle Children's Cancer Consortium
