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

PHASE3RecruitingINTERVENTIONAL
Enrollment

115

Participants

Timeline

Start Date

March 4, 2025

Primary Completion Date

July 31, 2028

Study Completion Date

July 31, 2028

Conditions
Anatomic Stage IV Breast Cancer AJCC v8Metastatic Breast CarcinomaMetastatic Lung Non-Small Cell CarcinomaMetastatic Malignant Neoplasm in the LeptomeningesStage IV Lung Cancer AJCC v8
Interventions
PROCEDURE

Biospecimen Collection

Undergo blood and CSF sample collection

PROCEDURE

Computed Tomography

Undergo CT or PET/CT

RADIATION

Involved-Field Radiation Therapy

Undergo IFRT

PROCEDURE

Lumbar Puncture

Undergo LP

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

RADIATION

Proton Beam Craniospinal Irradiation

Undergo pCSI

OTHER

Quality-of-Life Assessment

Ancillary studies

Trial Locations (56)

10016

RECRUITING

Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York

10035

RECRUITING

New York Proton Center, New York

10065

RECRUITING

Memorial Sloan Kettering Cancer Center, New York

10461

RECRUITING

Montefiore Medical Center-Einstein Campus, The Bronx

10467

RECRUITING

Montefiore Medical Center - Moses Campus, The Bronx

10604

RECRUITING

Memorial Sloan Kettering Westchester, Harrison

11501

RECRUITING

NYU Langone Hospital - Long Island, Mineola

11553

RECRUITING

Memorial Sloan Kettering Nassau, Uniondale

11725

RECRUITING

Memorial Sloan Kettering Commack, Commack

20016

RECRUITING

Sibley Memorial Hospital, Washington D.C.

20176

RECRUITING

Inova Loudoun Hospital, Leesburg

21287

RECRUITING

Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore

22031

RECRUITING

Inova Schar Cancer Institute, Fairfax

22033

RECRUITING

Inova Fair Oaks Hospital, Fairfax

22304

RECRUITING

Inova Alexandria Hospital, Alexandria

33136

RECRUITING

University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami

33146

RECRUITING

UM Sylvester Comprehensive Cancer Center at Coral Gables, Coral Gables

33166

RECRUITING

UM Sylvester Comprehensive Cancer Center at Doral, Doral

33176

RECRUITING

Miami Cancer Institute, Miami

RECRUITING

UM Sylvester Comprehensive Cancer Center at Kendall, Miami

33180

RECRUITING

UM Sylvester Comprehensive Cancer Center at Aventura, Aventura

33324

RECRUITING

UM Sylvester Comprehensive Cancer Center at Plantation, Plantation

33442

RECRUITING

UM Sylvester Comprehensive Cancer Center at Deerfield Beach, Deerfield Beach

43210

RECRUITING

Ohio State University Comprehensive Cancer Center, Columbus

48201

RECRUITING

Wayne State University/Karmanos Cancer Institute, Detroit

48334

RECRUITING

Weisberg Cancer Treatment Center, Farmington Hills

48532

RECRUITING

McLaren Cancer Institute-Flint, Flint

48910

RECRUITING

Karmanos Cancer Institute at McLaren Greater Lansing, Lansing

55905

RECRUITING

Mayo Clinic in Rochester, Rochester

60115

RECRUITING

Northwestern Medicine Cancer Center Kishwaukee, DeKalb

60134

RECRUITING

Northwestern Medicine Cancer Center Delnor, Geneva

60555

RECRUITING

Northwestern Medicine Cancer Center Warrenville, Warrenville

60611

RECRUITING

Northwestern University, Chicago

62002

RECRUITING

Alton Memorial Hospital, Alton

62269

RECRUITING

Memorial Hospital East, Shiloh

63110

RECRUITING

Washington University School of Medicine, St Louis

63128

RECRUITING

Mercy Hospital South, St Louis

63129

RECRUITING

Siteman Cancer Center-South County, St Louis

63136

RECRUITING

Siteman Cancer Center at Christian Hospital, St Louis

63141

RECRUITING

Siteman Cancer Center at West County Hospital, Creve Coeur

63376

RECRUITING

Siteman Cancer Center at Saint Peters Hospital, City of Saint Peters

64064

RECRUITING

University of Kansas Cancer Center - Lee's Summit, Lee's Summit

64154

RECRUITING

University of Kansas Cancer Center - North, Kansas City

65804

RECRUITING

Mercy Hospital Springfield, Springfield

66160

RECRUITING

University of Kansas Cancer Center, Kansas City

66210

RECRUITING

University of Kansas Cancer Center-Overland Park, Overland Park

72205

RECRUITING

University of Arkansas for Medical Sciences, Little Rock

73104

RECRUITING

University of Oklahoma Health Sciences Center, Oklahoma City

84112

RECRUITING

Huntsman Cancer Institute/University of Utah, Salt Lake City

92024

RECRUITING

UC San Diego Health System - Encinitas, Encinitas

92093

RECRUITING

UC San Diego Moores Cancer Center, La Jolla

92103

RECRUITING

UC San Diego Medical Center - Hillcrest, San Diego

92121

RECRUITING

California Protons Cancer Therapy Center, San Diego

07920

RECRUITING

Memorial Sloan Kettering Basking Ridge, Basking Ridge

07748

RECRUITING

Memorial Sloan Kettering Monmouth, Middletown

07645

RECRUITING

Memorial Sloan Kettering Bergen, Montvale

Sponsors

Lead Sponsor

All Listed Sponsors
lead

NRG Oncology

OTHER