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NCT Number: NCT06984523

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

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).

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Key information

Conditions

Leptomeningeal Metastasis Central Nervous System Neoplasms Meningeal Carcinomatosis Meningeal Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • If of reproductive age, must practice effective contraceptive method

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Time to central nervous system (CNS) progression free survival

    Time frame: From baseline up to 1 year from end of treatment

    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.

Secondary outcomes

  1. Overall survival

    Time frame: From baseline up to 1 year from end of treatment

    Overall survival will be estimated using Kaplan Meier methods for censored data that includes deaths as events.

  2. Time to CNS progression

    Time frame: From baseline up to 1 year from end of treatment

    Time to CNS progression will be analyzed using competing risk methods, considering death and progression from other causes as competing risks.

  3. Rate of cessation of systemic therapy

    Time frame: 1 year post-treatment

  4. Number of treatment-related adverse events

    Time frame: End of study (up to 2 years)

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

    Time frame: End of study (up to 2 years)

    The MDASI-BT includes 22 items assessing severity of brain tumor symptoms and 6 items assessing interference. Symptom severity and interference are assessed on a scale from 0-10 scale. A score of 0 indicates "not present" or "did not interfere," while a score of 10 represents "as bad as you can imagine" or "interfered completely". Scores range from 0-280. Higher scores indicate the brain tumor significantly impairs daily functioning.

  6. M. D. Anderson Symptom Inventory - Spine Tumor (MDASI-SP) score

    Time frame: End of study (up to 2 years)

    The MDASI-SP includes 18 items assessing severity spinal tumor symptoms and 6 items assessing interference. Symptom severity and interference are assessed on a scale from 0-10 scale. A score of 0 indicates "not present" or "did not interfere," while a score of 10 represents "as bad as you can imagine" or "interfered completely". Scores range from 0-240. Higher scores indicate the brain tumor significantly impairs daily functioning.

  7. Functional Assessment of Cancer Therapy - Brain (FACT-Br) score

    Time frame: End of study (up to 2 years)

    The FACT-Brain (FACT-Br) is one such instrument that assesses brain-tumor related QOL issues. The questionnaire consists of the FACT-G plus a brain-tumor specific scale. A total of 50 items are included that cover the following domains of QOL: physical well-being, social/family well-being, emotional well-being, functional well-being, and disease specific concerns. Patients are asked to indicate the presence/severity of certain issues/symptoms on a scale of 0 - 4 (a 5-point Likert Scale). Higher scores indicate decreased health-related quality of life.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

A Phase II Single-Arm Study of Craniospinal Irradiation With Linac Based Volumetric Modulated Arc Therapy (VMAT) for Patients With Leptomeningeal Metastasis

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
May 22, 2025
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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