Proton Radiation Therapy for Leptomeningeal Metastasis

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

Recruiting Phase 3 Interventional Study
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
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
115 (estimated)
Sponsor
NRG Oncology · Other
Who this trial is looking for

This trial is looking for patients with breast or lung cancer that has spread to the fluid around the brain and spinal cord. Participants will compare two types of radiation therapy to see which is more effective.

Are You a Good Fit for This Trial?
Rules you out Prior treatment for leptomeningeal metastasisNew York Heart Association Functional Classification III or IV

You may be able to join if

  • I have been diagnosed with breast cancer or non-small cell lung cancer.
  • I have newly diagnosed leptomeningeal metastasis.
  • I am at least 18 years old.
  • I am eligible for radiation therapy.
  • I have a Karnofsky performance status of 60 or higher.
  • I have a hemoglobin level of at least 8.0 g/dl.
  • I have a platelet count of at least 100,000/mm^3.
  • I have negative urine or serum pregnancy test if applicable.

You may not be able to join if

  • I have had prior radiation therapy to the spinal cord that exceeds certain limits.
  • I have a history of unstable angina requiring hospitalization in the last 3 months.
  • I have had a heart attack in the last 3 months.
  • I currently have an active infection that needs IV antibiotics.
  • I have an active COPD exacerbation or other acute respiratory illness.
  • I have CTCAE v5.0 grade 2 or higher encephalopathy.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This 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 n…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * PRIOR TO STEP 1 REGISTRATION * Patients with pathologically (histologically or cytologically) proven diagnosis of breast cancer or NSCLC * Patients must have newly diagnosed leptomeningeal metastasis established through at least one of the following: * Positive CSF cytology…
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