RecruitingPhase 3

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

A Phase III Randomized Clinical Trial of Proton Craniospinal Irradiation Versus Involved-Field Radiotherapy for Patients With Breast Cancer or Non-Small Cell Lung Cancer Leptomeningeal Metastasis (Radiate-LM)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 months, 3 years
  • Procedures mentioned: X-rays, MRI scans, CT scans, Spinal tap (lumbar puncture), Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "RT uses high energy radiography (x-rays), particles, or radioactive seeds to kill cancer cells and shrink tumors."
  • "Patients undergo computed tomography (CT) or positron emission tomography (PET)/CT during screening and magnetic resonance imaging (MRI) as well as possible lumbar puncture (LP) throughout the study."
  • "Patients may optionally undergo research blood sample and CSF collection throughout the study."
  • "Patients undergo CT or PET/CT during screening and MRI as well as possible LP throughout the study."
  • "After completion of study treatment, patients are followed every 3 months for 12 months, and then every 6 months for up to 3 years from end of RT."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares proton radiation to the usual x-ray radiation for cancer that has spread to the fluid-filled space around the brain and spinal cord. It is for adults with breast cancer or non-small cell lung cancer. The study tests whether treating the whole brain and spinal cord area with protons works better than treating only certain areas with x-rays.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older, with breast cancer or non-small cell lung cancer confirmed by tissue or cell tests.
  • Have newly diagnosed cancer spread to the space around the brain and spinal cord, confirmed by fluid tests or scans with typical symptoms.
  • Be able to receive radiation treatment for this cancer spread.
  • Have financial approval for proton treatment and complete the second signup step within 30 days of the first.
  • Have standard scans to check cancer in the rest of the body.
  • Be able to care for most personal needs, though some help may be needed.
  • Meet the study’s blood count and liver test limits. Treatment to raise blood counts is allowed.
  • If able to become pregnant, have a negative pregnancy test within 14 days before signup.

Who can't join

  • Are pregnant or breastfeeding.
  • Have already had treatment for cancer in the fluid-filled space around the brain and spinal cord. Prior treatment for other brain or spinal cord disease is allowed.
  • Have had radiation above the study’s dose limits to the spinal cord or the bundle of nerves at its lower end.
  • Had a heart attack or were hospitalized for unstable chest pain in the past 3 months.
  • Have heart disease that causes symptoms with less than usual activity or while resting.
  • Have an active infection that needs antibiotics through a vein.
  • Have a flare-up of chronic lung disease or another sudden breathing illness that prevents study treatment.
  • Have moderate or worse problems with brain function, called encephalopathy.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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 or negative 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 leptomeningeal metastasis may have one or more of the following symptoms and signs: headache, nausea, vomiting, mental status change, gait difficulty, cranial nerve palsy, diplopia, visual change, hearing loss, radicular weakness, radicular sensory change, urinary retention, saddle anesthesia, constipation, neck pain, and back pain * For patients with prior history of immunotherapy or current immunotherapy, CSF sampling rather than just MRI enhancement is strongly recommended to exclude immune-related aseptic meningitis * Patients must be candidates for radiation therapy for the treatment of leptomeningeal metastasis * Age ≥ 18 * PRIOR TO STEP 2 REGISTRATION * Note: Step 2 registration must occur no later than 30 calendar days after step 1 registration * Financial clearance for proton therapy treatment * Patients must have systemic disease evaluation through standard of care imaging for example CT chest/abdomen/pelvis or body PET/CT * Karnofsky performance status ≥ 60 * Not pregnant and not nursing * Negative urine or serum pregnancy test (in persons of childbearing potential) within 14 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal * Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin \[Hgb\] ≥ 8.0 g/dl is acceptable) * Absolute neutrophil count (ANC) ≥ 1,000/mm\^3 (Note: the use of granulocyte-colony stimulating factor or other intervention to achieve ANC ≥ 1,000/mm\^3 is acceptable) * Platelets ≥ 100,000/mm\^3 (Note: the use of transfusion or other intervention to achieve platelets ≥ 100,000/mm\^3 is acceptable) * Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN) (patients with known Gilbert disease without other clinically significant liver abnormalities are not excluded) * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine transaminase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3 × ULN * No prior radiation therapy to the spinal cord with equivalent dose in 2 gray (Gy) fractions (EQD2) more than 40Gy or cauda equina with EQD2 more than 50Gy using alpha/beta ratio of 3 * No prior treatment for leptomeningeal metastasis (note: prior CNS treatment for other non-leptomeningeal disease is allowed) * No history of unstable angina requiring hospitalization in the last 3 months * No history of myocardial infarction within the last 3 months * New York Heart Association Functional Classification II or better (New York Heart Association \[NYHA\] Functional Classification III/IV are not eligible) (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.) * No active infection currently requiring intravenous (IV) antibiotic management * No active chronic obstructive pulmonary disease exacerbation or other acute respiratory illness precluding study therapy * No CTCAE v5.0 ≥ grade 2 encephalopathy

Study sites (58)

AR

AZ

CA

DC

FL

  • UM Sylvester Comprehensive Cancer Center at Aventura · Aventura, FL 33180Site Public Contact · Study contact · 954-461-2180Morgan Freret · Principal investigatorMore trials in Aventura
  • UM Sylvester Comprehensive Cancer Center at Coral Gables · Coral Gables, FL 33146Site Public Contact · Study contact · 305-243-2647Morgan Freret · Principal investigatorMore trials in Coral Gables
  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach · Deerfield Beach, FL 33442Site Public Contact · Study contact · 305-243-2647Morgan Freret · Principal investigatorMore trials in Deerfield Beach
  • UM Sylvester Comprehensive Cancer Center at Doral · Doral, FL 33166Site Public Contact · Study contact · kginnity@med.miami.eduMorgan Freret · Principal investigatorMore trials in Doral
  • University of Miami Miller School of Medicine-Sylvester Cancer Center · Miami, FL 33136Site Public Contact · Study contact · 305-243-2647Morgan Freret · Principal investigatorMore trials in Miami
  • Miami Cancer Institute · Miami, FL 33176Site Public Contact · Study contact · 786-596-2000Matthew D. Hall · Principal investigatorMore trials in Miami
  • UM Sylvester Comprehensive Cancer Center at Kendall · Miami, FL 33176Site Public Contact · Study contact · 305-243-2647Morgan Freret · Principal investigatorMore trials in Miami
  • UM Sylvester Comprehensive Cancer Center at Plantation · Plantation, FL 33324Site Public Contact · Study contact · 305-243-2647Morgan Freret · Principal investigatorMore trials in Plantation

IL

KS

MD

MI

MN

MO

NJ

NY

OH

OK

UT

VA