NRG-BN014: A PHASE III RANDOMIZED CLINICAL TRIAL OF PROTON CRANIOSPINAL IRRADIATION VERSUS INVOLVED-FIELD RADIOTHERAPY FOR PATIENTS WITH BREAST CANCER OR NON- SMALL CELL LUNG CANCER LEPTOMENINGEAL METASTASIS (RADIATE-LM)

This phase III trial compares proton craniospinal irradiation (pCSI) to involved-field radiation therapy (IFRT) for the treatment of breast or non-small cell lung cancer that has spread from where it first started to the cerebrospinal fluid filled space that surrounds the brain and spinal cord (leptomeningeal metastasis). Patients with leptomeningeal metastasis (LM) may develop multiple areas of nervous system (neurologic) impairment that can be life-threatening. Radiation therapy (RT) effectively relieves local symptoms due to LM. RT uses high energy radiography (x-rays), particles, or radioactive seeds to kill cancer cells and shrink tumors. IFRT is commonly used to treat symptoms of LM. IFRT is radiation treatment that uses x-rays to treat specific areas of LM and to relieve and/or prevent symptoms. pCSI uses protons that can be directed with more accuracy than x-rays which allows treatment of the entire central nervous system space containing the cerebrospinal fluid (CSF), brain, and spinal cord. The pCSI treatment could delay the worsening of LM. Giving pCSI may be better than IFRT in treating LM in patients with breast or non-small cell lung cancer.

Inova Schar Cancer Institute
A division of Inova Fairfax Hospital
8081 Innovation Park Drive 
Fairfax, VA 22031

Inova Fairfax Medical Center 
3300 Gallows Rd  
Falls Church, VA, 22042

Inova Loudon Hospital 
4055 Riverside Pkwy  
Leesburg, VA 20176

Inova Alexandria Hospital 
4320 Seminary Rd  
Alexandria, VA 22304

Inova Fair Oaks Hospital 
3600 Joseph Siewick Dr  
Fairfax, VA 22033

• Patients with pathologically (histologically or cytologically) proven diagnosis of breast cancer or NSCLC. Patients must have systemic disease evaluation through standard of care imaging for example CT chest/abdomen/pelvis or body PET/CT
• Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin [Hgb] ≥ 8.0 g/dl is acceptable)
• Absolute neutrophil count (ANC) ≥ 1,000/mm^3 (Note: the use of granulocyte-colony stimulating factor or other intervention to achieve ANC ≥ 1,000/mm^3 is acceptable)
• Platelets ≥ 100,000/mm^3 (Note: the use of transfusion or other intervention to achieve platelets ≥ 100,000/mm^3 is acceptable)
• Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN) (patients with known Gilbert disease without other clinically significant liver abnormalities are not excluded)
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine transaminase (ALT) (serum glutamic pyruvic transaminase [SGPT]) ≤ 3 × ULN
• No prior radiation therapy to the spinal cord with equivalent dose in 2 gray (Gy) fractions (EQD2) more than 40Gy or cauda equina with EQD2 more than 50Gy using alpha/beta ratio of 3

• Done prior treatment for leptomeningeal metastasis (note: prior CNS treatment for other non-leptomeningeal disease is allowed)
• Has  history of unstable angina requiring hospitalization in the last 3 months
• Has history of myocardial infarction within the last 3 months
• has active infection currently requiring intravenous (IV) antibiotic management

• Has active chronic obstructive pulmonary disease exacerbation or other acute respiratory illness precluding study therapy

  For more information, visit: https://clinicaltrials.gov/study/NCT06500481