A Multi-center Phase 2 Study of Hippocampal Avoidance in Craniospinal Irradiation for Leptomeningeal Metastases from Solid Tumors

Brief description of study

This is a Phase 2 clinical study done at multiple hospitals that is testing a special type of radiation treatment called craniospinal irradiation (CSI) with hippocampal avoidance in patients who have cancer that has spread to the brain and spinal fluid (leptomeningeal metastases) from solid tumors. All patients in the study will receive standard cancer treatments chosen by their doctor, along with a special type of radiation treatment. During screening, patients have a full medical history, physical exam, blood tests, and MRI scans of the brain and spine to assess the extent of disease. A detailed neurological exam using the NANO scale is also performed, and all patients must give written informed consent. A spinal fluid test may be done, but it is optional.

All patients then receive craniospinal irradiation (CSI) using either proton or photon VMAT radiation, with a technique called hippocampal avoidance to help protect memory-related areas of the brain. The planned radiation dose is 30 Gy in divided doses, though it may be adjusted if needed to protect healthy tissue. Some patients may also receive memantine, a medication that can help reduce memory and thinking side effects from radiation. Treatment planning follows strict safety and quality guidelines to ensure accurate delivery. After treatment, patients are closely followed at 3, 6, 9, and 12 months, with flexibility of about ±4 weeks for scheduling. At each visit, patients undergo MRI scans of the brain and spine to monitor how the cancer is responding and to check for any signs of disease progression. Additional scans are done if there are concerns about worsening disease in the central nervous system. Overall, the study focuses on evaluating how effective and safe this radiation approach is while also trying to protect brain function and preserve quality of life over time.


Clinical Study Identifier: s26-00443
ClinicalTrials.gov Identifier: NCT06518057
Principal Investigator: Jonathan Tzu-l Yang.
Other Investigators: Caitlin Elizabeth Ordonez Ferri, Minerva A Utate, Jessica D. Schulte, Alexandra M. Miller, Alexandra Gewirtz, Neil L. Sielski, Jessica Goggin, Lynda Julie Boulio-Castillo, Jennifer H Fisher, Benjamin Cooper, Jacqueline Li, Ryan C Mitchell, Marissa Barbaro, Joshua S. Silverman, Jose Ricardo McFaline Figueroa.


If you are registered as a volunteer, please log in to contact the study team/express interest in this study.

Contact the research team to learn more about this study.

By clicking "Contact Research Team", your contact information will be sent securely to the research staff associated with the study. You will also receive a copy of this email in your inbox, as well as other notifications to determine your participation status in the study.