Testing Proton Craniospinal Radiation Therapy Versus the Usual Radiation Therapy for Leptomeningeal Metastasis, RADIATE-LM Trial (NCT06500481)
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)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Mayo Clinic Hospital in Arizona — Phoenix, Arizona
Age range: 18 Years
🧪 Interventions in This Study
- Biospecimen Collection (PROCEDURE)
- Computed Tomography (PROCEDURE)
- Involved-Field Radiation Therapy (RADIATION)
- Lumbar Puncture (PROCEDURE)
- Magnetic Resonance Imaging (PROCEDURE)
- Positron Emission Tomography (PROCEDURE)
- Proton Beam Craniospinal Irradiation (RADIATION)
- Quality-of-Life Assessment (OTHER)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (58 Sites)
Showing the first 25 of 58 sites.
- Mayo Clinic Hospital in Arizona — Phoenix, Arizona
- University of Arkansas for Medical Sciences — Little Rock, Arkansas
- UC San Diego Health System - Encinitas — Encinitas, California
- UC San Diego Moores Cancer Center — La Jolla, California
- UC San Diego Medical Center - Hillcrest — San Diego, California
- California Protons Cancer Therapy Center — San Diego, California
- Sibley Memorial Hospital — Washington D.C., District of Columbia
- UM Sylvester Comprehensive Cancer Center at Aventura — Aventura, Florida
- UM Sylvester Comprehensive Cancer Center at Coral Gables — Coral Gables, Florida
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach — Deerfield Beach, Florida
- UM Sylvester Comprehensive Cancer Center at Doral — Doral, Florida
- University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami, Florida
- Miami Cancer Institute — Miami, Florida
- UM Sylvester Comprehensive Cancer Center at Kendall — Miami, Florida
- UM Sylvester Comprehensive Cancer Center at Plantation — Plantation, Florida
- Alton Memorial Hospital — Alton, Illinois
- Northwestern University — Chicago, Illinois
- Northwestern Medicine Cancer Center Kishwaukee — DeKalb, Illinois
- Northwestern Medicine Cancer Center Delnor — Geneva, Illinois
- Memorial Hospital East — Shiloh, Illinois
- Northwestern Medicine Cancer Center Warrenville — Warrenville, Illinois
- University of Kansas Cancer Center — Kansas City, Kansas
- University of Kansas Cancer Center-Overland Park — Overland Park, Kansas
- Johns Hopkins University/Sidney Kimmel Cancer Center — Baltimore, Maryland
- Wayne State University/Karmanos Cancer Institute — Detroit, Michigan
📞 Contact the Study Coordinator
Phone: (855) 776-0015
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.