December 12 2024
The NRG-BN014 clinical trial, also known as the “RADIATE-LM” study, is designed to compare proton craniospinal radiation therapy (pCSI) versus involved-field radiation therapy (IFRT) for patients with breast cancer or non-small cell lung cancer leptomeningeal metastasis (LM). This trial activated to patient enrollment in November 2025.
“Currently, IFRT is the usual radiation treatment approach to patients with LM and prognosis for this population is often poor. The average overall survival for patients being treated for LM is approximately 4-6 months with standard approaches.”, stated Jonathan T. Yang, MD, PhD, of the New York University School of Medicine and Perlmutter Cancer Center. Dr. Yang is also the Principal Investigator of the RADIATE-LM Trial.
LM is more commonly associated with lung and breast cancers and the incidence of LM is rising, likely due to improved imaging techniques and systemic disease control. Patients with LM typically develop multiple debilitating neurological dysfunctions that can be life-threatening due to the disease’s dissemination through the central nervous system (CNS).
“Proton craniospinal radiation therapy has showed potential promise in improving survival outcomes for this population as well as limited high-grade toxicities due to its more targeted delivery of radiation,” Dr. Yang added.
After receiving clearance for proton therapy, patients enrolled on the RADIATE-LM study will be registered and stratified by histology (breast cancer or non-small cell lung cancer), systemic disease status, and use of intrathecal therapy/immunotherapy/targeted therapy including antibody-drug conjugates either 4 weeks prior or planned 4 weeks following completion of radiotherapy. Patients will then be randomly assigned to either Treatment Arm 1 receiving IFRT or to Treatment Arm 2 receiving pCSI. The primary aim of this trial is to determine if pCSI improves overall survival outcomes when compared to the usual IFRT.
Additional objectives of the RADIATE-LM study include comparing CNS progression-free survival, CNS progression rates, treatment-related adverse events, radiation-induces CNS necrosis rates and patient-reported outcomes between treatment arms.
More Study Information
Learn more about this trial at ClinicalTrials.gov
Protocol documents and materials are located on the CTSU website