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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new radiation treatment called Linac Based Volumetric Modulated Arc Therapy (VMAT) for individuals with solid tumor cancers that have spread to the brain and spine. The goal is to determine if this treatment can better prevent cancer progression in the central nervous system compared to the usual radiation method. Individuals with a solid tumor cancer diagnosis, whose cancer has spread to the brain or spine, and who are suitable candidates for radiation therapy may be eligible to join. Participants should not have multiple severe neurological issues and must be able to undergo an MRI scan. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for those seeking alternatives to traditional methods.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that linac based VMAT is safe for craniospinal irradiation in solid tumor cancer patients with leptomeningeal metastasis?

Research has shown that Volumetric Modulated Arc Therapy (VMAT), a type of radiation therapy, is generally well-tolerated for treating cancer in the brain and spine. Studies have found that VMAT often causes fewer side effects than some traditional radiation methods. Patients typically experience less discomfort because VMAT targets tumors more precisely, protecting the surrounding healthy tissue. While side effects like tiredness or skin irritation can still occur, they are usually mild and manageable. VMAT is already used to treat other types of tumors, indicating a strong safety record in radiation therapy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Linac Based Volumetric Modulated Arc Therapy (VMAT) for leptomeningeal metastasis because it offers precise targeting of cancer cells with radiation. Unlike traditional radiation therapies, which can affect a broader area and potentially harm healthy tissues, VMAT delivers radiation in a more controlled manner, reducing side effects. This method allows for daily treatments over a shorter period, potentially improving patient comfort and compliance compared to longer, more invasive treatment schedules.

What evidence suggests that linac based VMAT is effective for leptomeningeal metastasis?

Research has shown that a new treatment called Volumetric Modulated Arc Therapy (VMAT) might help patients with leptomeningeal metastasis, a condition where cancer spreads to the lining of the brain and spinal cord. This trial will specifically evaluate VMAT to determine if it can delay the progression of cancer in the central nervous system (CNS). Although direct results from this trial are not yet available, the goal is to assess whether VMAT can better control cancer growth compared to older methods like Involved Field Radiation Therapy (IFRT). This suggests that VMAT might be more effective than previous treatments for this challenging condition. ^{1 2 3 4 6}

Who Is on the Research Team?

Benjamin Cooper, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

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

Able to provide informed consent

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. trials.braintumor.org trials.braintumor.org/trials/NCT06984523

Study of Craniospinal Irradiation With Linac Based Volumetric ... The primary aim is to determine if linac based VMAT CSI for leptomeningeal metastasis improves central nervous system (CNS) progression free survival (PFS) ...

2. trial.medpath.com trial.medpath.com/clinical-trial/46c80ce30a293bdb/nct06984523-craniospinal-irradiation-vmat-leptomeningeal-metastasis

Study of Craniospinal Irradiation With Linac Based Volumetric ... The primary aim is to determine if linac based VMAT CSI for leptomeningeal metastasis improves central nervous system (CNS) progression free survival (PFS) ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7004932/

Focal Management of Large Brain Metastases and Risk of ... Surgery and postoperative radiosurgery (S + SRS) for brain metastases is associated with risk of developing leptomeningeal disease (LMD).

4. clinicaltrials.med.nyu.edu clinicaltrials.med.nyu.edu/cancer/clinicaltrial/2687/phase-ii-single-arm-study/

Clinical Trials & Research Studies - NYU The primary objective is to determine if linac based VMAT CSI for leptomeningeal metastases improves CNS progression free survival compared to historical ...

5. link.springer.com link.springer.com/article/10.1007/s12032-025-02970-4

Evaluation of the efficacy and safety of HyperArc ... This retrospective study analyzes HyperArc SRT outcomes in lung cancer brain metastasis (LCBM) patients to assess efficacy, safety, prognostic ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2405631624000617

Comparative study of dynamic conformal arc therapy and ... This retrospective study compared two SRT techniques, dynamic conformal arc therapy (DCAT) and volumetric modulated arc therapy (VMAT), for single BM ...