RecruitingPhase IIIEN original

Testing Proton Craniospinal Radiation Therapy Versus the Usual Radiation Therapy for Leptomeningeal Metastasis, RADIATE-LM Trial

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This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Potwierdzony rozpoznanie raka piersi lub płuc
  • Nowe ogniska przerzutów do opon mózgowych potwierdzone wynikami badań (dodatni wynik płynu mózgowo-rdzeniowego lub typowe objawy widoczne na zdjęciach)
  • Kwalifikacja do radioterapii
  • Wiek co najmniej 18 lat
  • Zdolność finansowa do leczenia terapią protonową
  • Ocena stanu ogólnego co najmniej 60 punktów
  • Hemoglobina co najmniej 8,0 g/dl
  • Liczba płytek krwi co najmniej 100 000/mm³

✗ Disqualifies

  • Ciąża lub karmienie piersią
  • Dodatni wynik testu ciążowego (w ostatnich 14 dni)
  • Zbyt wysokie wartości bilirubiny (powyżej 1,5 normy)
  • Zbyt wysokie wartości enzymów wątroby (powyżej 3 normy)

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
June 25, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (58)

Mayo Clinic Hospital in Arizona

Phoenix, United States

University of Arkansas for Medical Sciences

Little Rock, United States

UC San Diego Health System - Encinitas

Encinitas, United States

UC San Diego Moores Cancer Center

La Jolla, United States

UC San Diego Medical Center - Hillcrest

San Diego, United States

California Protons Cancer Therapy Center

San Diego, United States

Sibley Memorial Hospital

Washington D.C., United States

UM Sylvester Comprehensive Cancer Center at Aventura

Aventura, United States

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, United States

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, United States

UM Sylvester Comprehensive Cancer Center at Doral

Doral, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, United States

Miami Cancer Institute

Miami, United States

UM Sylvester Comprehensive Cancer Center at Kendall

Miami, United States

UM Sylvester Comprehensive Cancer Center at Plantation

Plantation, United States

Alton Memorial Hospital

Alton, United States

Northwestern University

Chicago, United States

Northwestern Medicine Cancer Center Kishwaukee

DeKalb, United States

Northwestern Medicine Cancer Center Delnor

Geneva, United States

Memorial Hospital East

Shiloh, United States

Northwestern Medicine Cancer Center Warrenville

Warrenville, United States

University of Kansas Cancer Center

Kansas City, United States

University of Kansas Cancer Center-Overland Park

Overland Park, United States

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, United States

Wayne State University/Karmanos Cancer Institute

Detroit, United States

Weisberg Cancer Treatment Center

Farmington Hills, United States

McLaren Cancer Institute-Flint

Flint, United States

Karmanos Cancer Institute at McLaren Greater Lansing

Lansing, United States

Mayo Clinic in Rochester

Rochester, United States

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, United States

Siteman Cancer Center at West County Hospital

Creve Coeur, United States

University of Kansas Cancer Center - North

Kansas City, United States

University of Kansas Cancer Center - Lee's Summit

Lee's Summit, United States

Mercy Hospital Springfield

Springfield, United States

Washington University School of Medicine

St Louis, United States

Mercy Hospital South

St Louis, United States

Siteman Cancer Center-South County

St Louis, United States

Siteman Cancer Center at Christian Hospital

St Louis, United States

Memorial Sloan Kettering Basking Ridge

Basking Ridge, United States

Memorial Sloan Kettering Monmouth

Middletown, United States

Memorial Sloan Kettering Bergen

Montvale, United States

NYU Langone Hospital - Brooklyn

Brooklyn, United States

Memorial Sloan Kettering Commack

Commack, United States

Memorial Sloan Kettering Westchester

Harrison, United States

NYU Langone Hospital - Long Island

Mineola, United States

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, United States

New York Proton Center

New York, United States

Memorial Sloan Kettering Cancer Center

New York, United States

Montefiore Medical Center-Einstein Campus

The Bronx, United States

Montefiore Medical Center - Moses Campus

The Bronx, United States

Memorial Sloan Kettering Nassau

Uniondale, United States

Ohio State University Comprehensive Cancer Center

Columbus, United States

University of Oklahoma Health Sciences Center

Oklahoma City, United States

Huntsman Cancer Institute/University of Utah

Salt Lake City, United States

Inova Alexandria Hospital

Alexandria, United States

Inova Schar Cancer Institute

Fairfax, United States

Inova Fair Oaks Hospital

Fairfax, United States

Inova Loudoun Hospital

Leesburg, United States

Trial contact

Site Public Contact

Eric Lehrer

PRINCIPAL_INVESTIGATOR

Site Public Contact

Fen Xia

PRINCIPAL_INVESTIGATOR

Site Public Contact

Jona A. Hattangadi-Gluth

PRINCIPAL_INVESTIGATOR

Site Public Contact

Site Public Contact

Carmen Kut

PRINCIPAL_INVESTIGATOR

Site Public Contact

Morgan Freret

PRINCIPAL_INVESTIGATOR

Site Public Contact

Site Public Contact

Site Public Contact

Matthew D. Hall

PRINCIPAL_INVESTIGATOR

Site Public Contact

Nikhil Rammohan

PRINCIPAL_INVESTIGATOR

Vinai Gondi

PRINCIPAL_INVESTIGATOR

Danielle Cunningham

PRINCIPAL_INVESTIGATOR

Site Public Contact

Brian K. Yeh

PRINCIPAL_INVESTIGATOR

Site Public Contact

Jay W. Carlson

PRINCIPAL_INVESTIGATOR

Site Public Contact

Yao Yu

PRINCIPAL_INVESTIGATOR

Jonathan T. Yang

PRINCIPAL_INVESTIGATOR

Site Public Contact

Arpit M. Chhabra

PRINCIPAL_INVESTIGATOR

Jana L. Fox

PRINCIPAL_INVESTIGATOR

Joshua D. Palmer

PRINCIPAL_INVESTIGATOR

Jerry J. Jaboin

PRINCIPAL_INVESTIGATOR

Rachna Malani

PRINCIPAL_INVESTIGATOR

Avani D. Rao

PRINCIPAL_INVESTIGATOR

Contact information from ClinicalTrials.gov. Contact in English.

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.