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

Launched by UNIVERSITY OF WASHINGTON · Jul 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new way to deliver radiation therapy called craniospinal irradiation (CSI) for patients with breast cancer or non-small cell lung cancer that has spread to the cerebrospinal fluid and the protective layers around the brain and spinal cord, known as leptomeningeal metastases. The goal is to see if using a technique called hippocampal avoidance can reduce side effects while still effectively treating the cancer. The hippocampus is a part of the brain that is crucial for memory, and avoiding it during radiation could help prevent neurological issues.

To be eligible for this trial, participants must be at least 18 years old and have confirmed leptomeningeal metastases from either breast cancer or non-small cell lung cancer. They also need to be able to tolerate radiation therapy and meet certain health criteria, such as having a sufficient blood count. Participants can expect to receive specialized radiation treatment while being monitored for side effects. It’s important to know that this trial is currently recruiting and aims to improve treatment options for patients facing these challenging conditions.

Gender

ALL

Eligibility criteria

• 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 an effective contraceptive method
• 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