Actively Recruiting
Testing Proton Craniospinal Radiation Therapy Versus the Usual Radiation Therapy for Leptomeningeal Metastasis, RADIATE-LM Trial
Led by NRG Oncology · Updated on 2026-05-07
115
Participants Needed
58
Research Sites
177 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Testing Proton Craniospinal Radiation Therapy Versus the Usual Radiation Therapy for Leptomeningeal Metastasis, RADIATE-LM Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with a confirmed diagnosis of breast cancer or non-small cell lung cancer
- Newly diagnosed leptomeningeal metastasis confirmed by positive cerebrospinal fluid cytology or by radiographic diagnosis with typical clinical signs
- Candidates for radiation therapy to treat leptomeningeal metastasis
- Age 18 years or older
- Step 2 registration within 30 days of initial registration
- Financial clearance for proton therapy treatment
- Systemic disease evaluation completed by standard imaging (e.g., CT chest/abdomen/pelvis or PET/CT)
- Karnofsky performance status of 60 or higher
- Not pregnant or nursing with a negative pregnancy test if of childbearing potential
- Hemoglobin level of 8.0 g/dl or higher (interventions allowed to reach this level)
- Absolute neutrophil count of 1,000/mm3 or higher (interventions allowed to reach this level)
- Platelet count of 100,000/mm3 or higher (interventions allowed to reach this level)
- Total bilirubin less than or equal to 1.5 times the institutional upper limit of normal
- AST and ALT levels less than or equal to 3 times the institutional upper limit of normal
- No prior radiation therapy to the spinal cord exceeding dose limits
- No prior treatment for leptomeningeal metastasis (prior CNS treatment for other diseases allowed)
- No recent unstable angina or myocardial infarction within the last 3 months
- New York Heart Association Functional Classification II or better
- No active infections requiring intravenous antibiotics
- No active respiratory illnesses preventing treatment
- No grade 2 or higher encephalopathy according to CTCAE v5.0
You will not qualify if you...
- History of unstable angina requiring hospitalization in the last 3 months
- History of myocardial infarction within the last 3 months
- New York Heart Association Functional Classification III or IV
- Active infection requiring intravenous antibiotic treatment
- Active exacerbation of chronic obstructive pulmonary disease or other respiratory illness preventing treatment
- CTCAE version 5.0 grade 2 or higher encephalopathy
- Prior radiation therapy to the spinal cord exceeding 40 Gy EQD2 or cauda equina exceeding 50 Gy EQD2
- Prior treatment for leptomeningeal metastasis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 58 locations
1
Mayo Clinic Hospital in Arizona
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Actively Recruiting
3
UC San Diego Health System - Encinitas
Encinitas, California, United States, 92024
Actively Recruiting
4
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Actively Recruiting
5
UC San Diego Medical Center - Hillcrest
San Diego, California, United States, 92103
Actively Recruiting
6
California Protons Cancer Therapy Center
San Diego, California, United States, 92121
Actively Recruiting
7
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States, 20016
Actively Recruiting
8
UM Sylvester Comprehensive Cancer Center at Aventura
Aventura, Florida, United States, 33180
Actively Recruiting
9
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, United States, 33146
Actively Recruiting
10
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, United States, 33442
Actively Recruiting
11
UM Sylvester Comprehensive Cancer Center at Doral
Doral, Florida, United States, 33166
Actively Recruiting
12
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
13
Miami Cancer Institute
Miami, Florida, United States, 33176
Actively Recruiting
14
UM Sylvester Comprehensive Cancer Center at Kendall
Miami, Florida, United States, 33176
Actively Recruiting
15
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, United States, 33324
Actively Recruiting
16
Alton Memorial Hospital
Alton, Illinois, United States, 62002
Actively Recruiting
17
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
18
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, United States, 60115
Actively Recruiting
19
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, United States, 60134
Actively Recruiting
20
Memorial Hospital East
Shiloh, Illinois, United States, 62269
Actively Recruiting
21
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, United States, 60555
Actively Recruiting
22
University of Kansas Cancer Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
23
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, United States, 66210
Actively Recruiting
24
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States, 21287
Actively Recruiting
25
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
26
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, United States, 48334
Actively Recruiting
27
McLaren Cancer Institute-Flint
Flint, Michigan, United States, 48532
Actively Recruiting
28
Karmanos Cancer Institute at McLaren Greater Lansing
Lansing, Michigan, United States, 48910
Actively Recruiting
29
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
30
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, United States, 63376
Actively Recruiting
31
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, United States, 63141
Actively Recruiting
32
University of Kansas Cancer Center - North
Kansas City, Missouri, United States, 64154
Actively Recruiting
33
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, United States, 64064
Actively Recruiting
34
Mercy Hospital Springfield
Springfield, Missouri, United States, 65804
Actively Recruiting
35
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
36
Mercy Hospital South
St Louis, Missouri, United States, 63128
Actively Recruiting
37
Siteman Cancer Center-South County
St Louis, Missouri, United States, 63129
Actively Recruiting
38
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, United States, 63136
Actively Recruiting
39
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
40
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States, 07748
Actively Recruiting
41
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States, 07645
Actively Recruiting
42
NYU Langone Hospital - Brooklyn
Brooklyn, New York, United States, 11220
Actively Recruiting
43
Memorial Sloan Kettering Commack
Commack, New York, United States, 11725
Actively Recruiting
44
Memorial Sloan Kettering Westchester
East White Plains, New York, United States, 10604
Actively Recruiting
45
NYU Langone Hospital - Long Island
Mineola, New York, United States, 11501
Actively Recruiting
46
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States, 10016
Actively Recruiting
47
New York Proton Center
New York, New York, United States, 10035
Actively Recruiting
48
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
49
Montefiore Medical Center-Einstein Campus
The Bronx, New York, United States, 10461
Actively Recruiting
50
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States, 10467
Actively Recruiting
51
Memorial Sloan Kettering Nassau
Uniondale, New York, United States, 11553
Actively Recruiting
52
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
53
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
54
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
55
Inova Alexandria Hospital
Alexandria, Virginia, United States, 22304
Actively Recruiting
56
Inova Schar Cancer Institute
Fairfax, Virginia, United States, 22031
Actively Recruiting
57
Inova Fair Oaks Hospital
Fairfax, Virginia, United States, 22033
Actively Recruiting
58
Inova Loudoun Hospital
Leesburg, Virginia, United States, 20176
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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