Coral Gables, FLNCT06500481Now EnrollingIRB Ready

Leptomeningeal Metastasis Clinical Trial in Coral Gables, FL

Access cutting-edge leptomeningeal metastasis treatment through this phase 3 clinical trial at a research site in Coral Gables. Study-provided care at no cost to qualified participants.

Sponsored by NRG Oncology

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Expert Care in Coral Gables

Access leptomeningeal metastasis specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related leptomeningeal metastasis treatment provided free

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Check if you qualify for this leptomeningeal metastasis clinical trial in Coral Gables, FL

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Why Participate?

  • No-Cost Study Care

  • Local to Coral Gables

    Convenient for FL residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Coral Gables site if eligible
  4. 4Begin participation

About This Leptomeningeal Metastasis Study in Coral Gables

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) effective

Sponsor: NRG Oncology

Who Can Participate

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
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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Coral Gables?

Yes, this clinical trial (NCT06500481) has an active research site in Coral Gables, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Leptomeningeal Metastasis Treatment Options in Coral Gables, FL

If you're searching for leptomeningeal metastasis treatment options in Coral Gables, FL, this clinical trial (NCT06500481) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Coral Gables research site is actively enrolling participants for this phase 3 clinical trial. You'll receive care from experienced leptomeningeal metastasis specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all leptomeningeal metastasis clinical trials near you to find additional studies recruiting in your area.

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