VMAT for Leptomeningeal Metastasis

Overseen By Benjamin Cooper, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Severe neurologic deficits, Diffuse systemic disease, MRI intolerance, Prior radiation, Pregnancy, Prisoners

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

20 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to confirm the safety and efficacy of linac based Volumetric Modulated Arc Therapy (VMAT) for craniospinal irradiation (CSI) in solid tumor cancer patients with leptomeningeal metastasis. The primary aim is to determine if linac based VMAT CSI for leptomeningeal metastasis improves central nervous system (CNS) progression free survival (PFS) compared to the historical standard control CNS PFS in patients treated with Involved Field Radiation Therapy (IFRT).

Research Team

Benjamin Cooper, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

This trial is for solid tumor cancer patients with leptomeningeal metastasis, which means cancer has spread to the lining of the brain and spinal cord. Specific eligibility details are not provided, but typically participants must meet certain health standards.

Inclusion Criteria

Adequate hematologic baseline: Hemoglobin > 8g/dL, Absolute neutrophil count >1,000/mm3, Platelet count > 100,000/mm3

Able to provide informed consent

I am a candidate for radiation therapy for cancer spread to the lining of my brain and spinal cord.

Exclusion Criteria

Pregnant or lactating women

Patient is unable to undergo MRI brain and spine with gadolinium contrast

Prisoners

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive linac based Volumetric Modulated Arc Therapy (VMAT) for craniospinal irradiation once a day, Monday through Friday, for a total of ten fractions

2 weeks

10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments including CNS progression free survival and symptom inventories

1 year

Long-term follow-up

Participants are monitored for overall survival and quality of life assessments up to 2 years

2 years

Treatment Details

Interventions

• Linac Based Volumetric Modulated Arc Therapy (VMAT)

Trial Overview The study tests Volumetric Modulated Arc Therapy (VMAT) using Varian Eclipse for craniospinal irradiation in these patients. It aims to see if VMAT improves survival without CNS progression compared to traditional radiation therapy.

Participant Groups

Group I: Linac based Volumetric Arc Therapy (VMAT) CSI Experimental Treatment 1 Intervention

Radiation dose will be administered according to the physician's written directive. Treatment will be administered once a day, Monday through Friday, for a total of ten fractions.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+