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Compares treatment options for Anatomic Stage IV Breast Cancer AJCC v8
Official title Testing Proton Craniospinal Radiation Therapy Versus the Usual Radiation Therapy for Leptomeningeal Metastasis, RADIATE-LM Trial
ClinicalTrials.gov ID: NCT06500481
What this study is testing
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Time commitment: about 3 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Little Rock, Arkansas, United States
- Encinitas, California, United States
- La Jolla, California, United States
- San Diego, California, United States
- Washington D.C., District of Columbia, United States
- Aventura, Florida, United States
- Coral Gables, Florida, United States
- Deerfield Beach, Florida, United States
- Doral, Florida, United States
- Miami, Florida, United States
- Plantation, Florida, United States
- Alton, Illinois, United States
- Chicago, Illinois, United States
- DeKalb, Illinois, United States
- Geneva, Illinois, United States
- Shiloh, Illinois, United States
- Warrenville, Illinois, United States
- Kansas City, Kansas, United States
- Overland Park, Kansas, United States
+ 28 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 3 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Little Rock, Arkansas, United States; Encinitas, California, United States; La Jolla, California, United States; San Diego, California, United States; Washington D.C., District of Columbia, United States and 42 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.