NCT06500481 · NRG Oncology
Testing Proton Craniospinal Radiation Therapy Versus the Usual Radiation Therapy for Leptomeningeal Metastasis, RADIATE-LM Trial
What this study 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).
View original scientific description
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.
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
Primary outcome measures
Overall survival (OS)
Time frame: From randomization until death due to any cause, assessed up to 3 years
Will be event-driven and will be conducted when a total of 88 OS events (from both treatment arms) have been observed. The final analysis (if the trial does not stop early at an interim) is expected to occur roughly 45 months after study activation (including the initial 6-months ramp-up). All analyses (interim or final) will be done on a modified intent-to-treat (ITT) basis such that all randomized patients who have follow-up information will be included in the arm to which they are randomized regardless of what treatment the patients receive. Treatment comparisons will be based on the log-rank test. At the final analysis, if the test has an associated 1-sided p-value of 0.024 or less in favor of proton craniospinal irradiation (pCSI) (equivalently, Z \> 1.98), then the trial will conclude that the pCSI arm results in improved survival over the involved field radiotherapy (IFRT) arm.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- PRIOR TO STEP 1 REGISTRATION
- Patients with pathologically (histologically or cytologically) proven diagnosis of breast cancer or NSCLC. Patients must have systemic disease evaluation through standard of care imaging for example CT chest/abdomen/pelvis or body PET/CT
- Patients must have newly diagnosed leptomeningeal metastasis established through at least one of the following:
- Positive CSF cytology for malignancy
- CSF cytology with suspicious cells is considered positive; CSF cytology with atypical cells is considered equivocal and not positive
- Patients with an equivocal CSF cytology result, or not suitable for CSF sampling, radiographic diagnosis of leptomeningeal metastasis with linear and/or nodular disease and documentation of typical clinical signs (European Association of Neuro-Oncology \[EANO\]-European Society for Medical Oncology \[ESMO\] Diagnostic Criteria Type IIA-IIC) is required
- Patients with typical clinical signs of leptom
Where
- Phoenix, Arizona
- Little Rock, Arkansas
- Encinitas, California
- La Jolla, California
- San Diego, California
- Washington D.C., District of Columbia
- Aventura, Florida
- Coral Gables, Florida
- Deerfield Beach, Florida
- Doral, Florida
- Miami, Florida
- Plantation, Florida
And 36 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 25, 2026 · Source of record for eligibility and locations