Study of Craniospinal Irradiation With Linac Based Volumetric Modulated Arc Therapy (VMAT) for Patients With Leptomeningeal Metastasis

NCT06984523 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 24-01730
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Leptomeningeal Metastasis

Outcome Measures

Primary Outcomes (1)

• Time to central nervous system (CNS) progression free survival

  Time to CNS progression free survival will be estimated using Kaplan Meier methods for censored data that includes CNS progressions. CNS disease progression will be defined as new or worsening neurologic deficit unrelated to therapeutic intervention via neurological assessment using Neurologic Assessment in Neuro-Oncology (NANO) scale, cerebrospinal fluid (CSF) cytology being newly positive for malignancy after initially being negative, MRI brain with and without contrast or MRI total spine with and without contrast shows progression per the European Organization for Research and Treatment of Cancer (EORTC) Brain Tumor Group and the Response Assessment in Neuro-Oncology (RANO) scorecard.

  From baseline up to 1 year from end of treatment

Secondary Outcomes (7)

• Overall survival

  From baseline up to 1 year from end of treatment

• Time to CNS progression

  From baseline up to 1 year from end of treatment

• Rate of cessation of systemic therapy

  1 year post-treatment

• Number of treatment-related adverse events

  End of study (up to 2 years)

• M.D. Anderson Symptom Inventory - Brain Tumor (MDASI-BT) score

  End of study (up to 2 years)

Study Arms (1)

Linac based Volumetric Arc Therapy (VMAT) CSI

EXPERIMENTAL

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.

Radiation: Varian Eclipse

Interventions

Varian Eclipse RADIATION

Varian TrueBeam linear accelerator with photon beam Volumetric Modulated Arc Therapy (VMAT) capability. Subjects will receive 3000 centigray (cGy) in 10 fractions at 300 cGy per fraction.

Linac based Volumetric Arc Therapy (VMAT) CSI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Solid tumor cancer primary with leptomeningeal metastases established radiographically and/or by CSF cytology
• Candidate for radiation therapy for the treatment of leptomeningeal metastases
• If patient had prior radiation, a treatment plan can be generated that will not exceed normal tissue tolerances
• Patient must have reasonable systemic treatment options, as confirmed by their medical oncologist
• Age ≥ 18 years old
• Able to provide informed consent
• Karnofsky Performance Scale (KPS) ≥ 60
• Adequate hematologic baseline
• Hemoglobin \> 8g/dL
• Absolute neutrophil count \>1,000/mm3
• Platelet count \> 100,000/mm3
• Female subjects must either be of
• Non-reproductive potential (over 60 years old, or without menses for at least 1 year without an alternative medical cause)
• Have history of hysterectomy, bilateral tubal ligation, or bilateral oophorectomy
• Must have negative serum/urine pregnancy test

You may not qualify if:

• Patient has multiple severe neurologic deficits per physician assessment
• Patient has diffuse systemic disease without reasonable systemic therapy options
• Patient is unable to undergo MRI brain and spine with gadolinium contrast
• Prior radiation that would preclude development of a treatment plan that respects normal tissue constraints
• Pregnant or lactating women
• Prisoners

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Meningeal Carcinomatosis

Condition Hierarchy (Ancestors)

Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases

Study Officials

• Benjamin Cooper, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: May 22, 2025
• Study Start: May 14, 2025
• Primary Completion (Estimated): May 12, 2028
• Study Completion (Estimated): May 12, 2028
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Benjamin.cooper@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.

Locations

US (1)