Comparing two kinds of radiation for cancer that spread to the fluid around the brain and spine
Official title: Testing Proton Craniospinal Radiation Therapy Versus the Usual Radiation Therapy for Leptomeningeal Metastasis, RADIATE-LM Trial
Status: Recruiting. It is looking for patients now. Talk to your care team about whether it fits you.
The trial team last updated this record on .
The short version
Doctors are comparing two types of radiation for cancer in the fluid around the brain.
Read our full plain-language summary
What the trial team says
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.
Key facts
- Registry number
- NCT06500481
- Stage of testing
- Phase 3
- Conditions studied
- Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Metastatic Lung Non-Small Cell Carcinoma, Metastatic Malignant Neoplasm in the Leptomeninges, Stage IV Lung Cancer AJCC v8
Where it is running
This trial lists 58 sites.
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Arizona
- Mayo Clinic Hospital in Arizona (Phoenix)
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Arkansas
- University of Arkansas for Medical Sciences (Little Rock)
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California
- UC San Diego Health System - Encinitas (Encinitas)
- UC San Diego Moores Cancer Center (La Jolla)
- UC San Diego Medical Center - Hillcrest (San Diego)
- California Protons Cancer Therapy Center (San Diego)
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District of Columbia
- Sibley Memorial Hospital (Washington D.C.)
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Florida
- UM Sylvester Comprehensive Cancer Center at Aventura (Aventura)
- UM Sylvester Comprehensive Cancer Center at Coral Gables (Coral Gables)
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach (Deerfield Beach)
- UM Sylvester Comprehensive Cancer Center at Doral (Doral)
- University of Miami Miller School of Medicine-Sylvester Cancer Center (Miami)
- Miami Cancer Institute (Miami)
- UM Sylvester Comprehensive Cancer Center at Kendall (Miami)
- UM Sylvester Comprehensive Cancer Center at Plantation (Plantation)
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Illinois
- Alton Memorial Hospital (Alton)
- Northwestern University (Chicago)
- Northwestern Medicine Cancer Center Kishwaukee (DeKalb)
- Northwestern Medicine Cancer Center Delnor (Geneva)
- Memorial Hospital East (Shiloh)
- Northwestern Medicine Cancer Center Warrenville (Warrenville)
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Kansas
- University of Kansas Cancer Center (Kansas City)
- University of Kansas Cancer Center-Overland Park (Overland Park)
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Maryland
- Johns Hopkins University/Sidney Kimmel Cancer Center (Baltimore)
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Michigan
- Wayne State University/Karmanos Cancer Institute (Detroit)
- Weisberg Cancer Treatment Center (Farmington Hills)
- McLaren Cancer Institute-Flint (Flint)
- Karmanos Cancer Institute at McLaren Greater Lansing (Lansing)
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Minnesota
- Mayo Clinic in Rochester (Rochester)
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Missouri
- Siteman Cancer Center at Saint Peters Hospital (City of Saint Peters)
- Siteman Cancer Center at West County Hospital (Creve Coeur)
- University of Kansas Cancer Center - North (Kansas City)
- University of Kansas Cancer Center - Lee's Summit (Lee's Summit)
- Mercy Hospital Springfield (Springfield)
- Washington University School of Medicine (St Louis)
- Mercy Hospital South (St Louis)
- Siteman Cancer Center-South County (St Louis)
- Siteman Cancer Center at Christian Hospital (St Louis)
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New Jersey
- Memorial Sloan Kettering Basking Ridge (Basking Ridge)
- Memorial Sloan Kettering Monmouth (Middletown)
- Memorial Sloan Kettering Bergen (Montvale)
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New York
- NYU Langone Hospital - Brooklyn (Brooklyn)
- Memorial Sloan Kettering Commack (Commack)
- Memorial Sloan Kettering Westchester (Harrison)
- NYU Langone Hospital - Long Island (Mineola)
- Laura and Isaac Perlmutter Cancer Center at NYU Langone (New York)
- New York Proton Center (New York)
- Memorial Sloan Kettering Cancer Center (New York)
- Montefiore Medical Center-Einstein Campus (The Bronx)
- Montefiore Medical Center - Moses Campus (The Bronx)
- Memorial Sloan Kettering Nassau (Uniondale)
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Ohio
- Ohio State University Comprehensive Cancer Center (Columbus)
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Oklahoma
- University of Oklahoma Health Sciences Center (Oklahoma City)
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Utah
- Huntsman Cancer Institute/University of Utah (Salt Lake City)
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Virginia
- Inova Alexandria Hospital (Alexandria)
- Inova Schar Cancer Institute (Fairfax)
- Inova Fair Oaks Hospital (Fairfax)
- Inova Loudoun Hospital (Leesburg)
How to use this
Talk to your care team first. They know your history and can tell you whether this trial is worth your time.
Joining a trial is always your choice. A trial is a test, not a proven treatment. Being in one is not a promise that it will help you.
This page is built from the trial's listing on ClinicalTrials.gov, a service of the U.S. National Library of Medicine. That listing is the authority, and it may have changed since we last read it. We do not run this trial and we cannot enroll you in it.