Phase 2 Study of Photon Craniospinal Irradiation Using VMAT for Leptomeningeal Disease from Breast or Non-Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating how well a type of radiation therapy called photon volumetric modulated arc radiotherapy VMAT craniospinal irradiation CSI works for patients with breast cancer or non-small cell lung cancer NSCLC that has spread to the cerebrospinal fluid and meninges, causing leptomeningeal disease. This phase II trial aims to assess the treatments effectiveness in controlling cancer in the central nervous system and its impact on patient quality of life and side effects. The study also explores biological markers related to inflammation and genetic predictors of disease progression. Participants receive photon-VMAT-CSI once daily for 10 treatments over 10 to 20 days Monday through Friday, provided there is no disease progression or unacceptable side effects. Before and after treatment, patients undergo MRI scans, blood draws, and cerebrospinal fluid collection through lumbar puncture or Ommaya reservoir tap. These procedures help monitor treatment response and collect samples for exploring biological markers. During the study, patients complete questionnaires assessing quality of life, anxiety, and cognitive function at multiple time points, including baseline, one month after treatment, and every three months up to one year. Researchers track central nervous system progression-free survival, overall survival, radiographic response, and treatment toxicities. Follow-up visits occur one month after treatment and then every three months for up to a year to monitor disease status and patient well-being.

Photon Craniospinal Irradiation for the Treatment of Leptomeningeal Disease Secondary to Breast Cancer or Non-small Cell Lung Cancer