Testing Proton Craniospinal Radiation Therapy Versus the Usual Radiation Therapy for Leptomeningeal Metastasis, RADIATE-LM Trial
NCT06500481
This study is recruiting at 58 US sites in 17 states, according to its ClinicalTrials.gov record last updated .
Summary
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.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
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
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 3
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- NRG Oncology
- Last updated on ClinicalTrials.gov
- August 17, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Arizona · 1
- Mayo Clinic Hospital in Arizona · Phoenix, AZ
Arkansas · 1
- University of Arkansas for Medical Sciences · Little Rock, AR
California · 4
- UC San Diego Health System - Encinitas · Encinitas, CA
- UC San Diego Moores Cancer Center · La Jolla, CA
- California Protons Cancer Therapy Center · San Diego, CA
- UC San Diego Medical Center - Hillcrest · San Diego, CA
District of Columbia · 1
- Sibley Memorial Hospital · Washington D.C., DC
Florida · 8
- UM Sylvester Comprehensive Cancer Center at Aventura · Aventura, FL
- UM Sylvester Comprehensive Cancer Center at Coral Gables · Coral Gables, FL
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach · Deerfield Beach, FL
- UM Sylvester Comprehensive Cancer Center at Doral · Doral, FL
- Miami Cancer Institute · Miami, FL
- UM Sylvester Comprehensive Cancer Center at Kendall · Miami, FL
- University of Miami Miller School of Medicine-Sylvester Cancer Center · Miami, FL
- UM Sylvester Comprehensive Cancer Center at Plantation · Plantation, FL
Illinois · 6
- Alton Memorial Hospital · Alton, IL
- Northwestern University · Chicago, IL
- Northwestern Medicine Cancer Center Kishwaukee · DeKalb, IL
- Northwestern Medicine Cancer Center Delnor · Geneva, IL
- Memorial Hospital East · Shiloh, IL
- Northwestern Medicine Cancer Center Warrenville · Warrenville, IL
Kansas · 2
- University of Kansas Cancer Center · Kansas City, KS
- University of Kansas Cancer Center-Overland Park · Overland Park, KS
Maryland · 1
- Johns Hopkins University/Sidney Kimmel Cancer Center · Baltimore, MD
Michigan · 4
- Wayne State University/Karmanos Cancer Institute · Detroit, MI
- Weisberg Cancer Treatment Center · Farmington Hills, MI
- McLaren Cancer Institute-Flint · Flint, MI
- Karmanos Cancer Institute at McLaren Greater Lansing · Lansing, MI
Minnesota · 1
- Mayo Clinic in Rochester · Rochester, MN
Missouri · 9
- Siteman Cancer Center at Saint Peters Hospital · City of Saint Peters, MO
- Siteman Cancer Center at West County Hospital · Creve Coeur, MO
- University of Kansas Cancer Center - North · Kansas City, MO
- University of Kansas Cancer Center - Lee's Summit · Lee's Summit, MO
- Mercy Hospital Springfield · Springfield, MO
- Mercy Hospital South · St Louis, MO
- Siteman Cancer Center at Christian Hospital · St Louis, MO
- Siteman Cancer Center-South County · St Louis, MO
- Washington University School of Medicine · St Louis, MO
New Jersey · 3
- Memorial Sloan Kettering Basking Ridge · Basking Ridge, NJ
- Memorial Sloan Kettering Monmouth · Middletown, NJ
- Memorial Sloan Kettering Bergen · Montvale, NJ
New York · 10
- NYU Langone Hospital - Brooklyn · Brooklyn, NY
- Memorial Sloan Kettering Commack · Commack, NY
- Memorial Sloan Kettering Westchester · Harrison, NY
- NYU Langone Hospital - Long Island · Mineola, NY
- Laura and Isaac Perlmutter Cancer Center at NYU Langone · New York, NY
- Memorial Sloan Kettering Cancer Center · New York, NY
- New York Proton Center · New York, NY
- Montefiore Medical Center - Moses Campus · The Bronx, NY
- Montefiore Medical Center-Einstein Campus · The Bronx, NY
- Memorial Sloan Kettering Nassau · Uniondale, NY
Ohio · 1
- Ohio State University Comprehensive Cancer Center · Columbus, OH
Oklahoma · 1
- University of Oklahoma Health Sciences Center · Oklahoma City, OK
Utah · 1
- Huntsman Cancer Institute/University of Utah · Salt Lake City, UT
Virginia · 4
- Inova Alexandria Hospital · Alexandria, VA
- Inova Fair Oaks Hospital · Fairfax, VA
- Inova Schar Cancer Institute · Fairfax, VA
- Inova Loudoun Hospital · Leesburg, VA
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.