Clinical trial NCT06984523: Study of Craniospinal Irradiation With Linac Based Volumetric Modulated Arc Therapy (VMAT) for Patients With Leptomeningeal Metastasis
Official title: A Phase II Single-Arm Study of Craniospinal Irradiation With Linac Based Volumetric Modulated Arc Therapy (VMAT) for Patients With Leptomeningeal Metastasis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Leptomeningeal Metastasis
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2025-05-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

1. Solid tumor cancer primary with leptomeningeal metastases established radiographically and/or by CSF cytology
2. Candidate for radiation therapy for the treatment of leptomeningeal metastases
3. If patient had prior radiation, a treatment plan can be generated that will not exceed normal tissue tolerances
4. Patient must have reasonable systemic treatment options, as confirmed by their medical oncologist
5. Age ≥ 18 years old
6. Able to provide informed consent
7. Karnofsky Performance Scale (KPS) ≥ 60
8. Adequate hematologic baseline

   1. Hemoglobin \> 8g/dL
   2. Absolute neutrophil count \>1,000/mm3
   3. Platelet count \> 100,000/mm3
9. Female subjects must either be of

   1. Non-reproductive potential (over 60 years old, or without menses for at least 1 year without an alternative medical cause)
   2. Have history of hysterectomy, bilateral tubal ligation, or bilateral oophorectomy
   3. Must have negative serum/urine pregnancy test
   4. If of reproductive age, must practice effective contraceptive method

Exclusion Criteria:

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

Primary outcomes:
measure: Time to central nervous system (CNS) progression free survival
timeFrame: From baseline up to 1 year from end of treatment
Secondary outcomes:
measure: Overall survival
timeFrame: From baseline up to 1 year from end of treatment
measure: Time to CNS progression
timeFrame: From baseline up to 1 year from end of treatment
measure: Rate of cessation of systemic therapy
timeFrame: 1 year post-treatment
measure: Number of treatment-related adverse events
timeFrame: End of study (up to 2 years)
measure: M.D. Anderson Symptom Inventory - Brain Tumor (MDASI-BT) score
timeFrame: End of study (up to 2 years)
measure: M. D. Anderson Symptom Inventory - Spine Tumor (MDASI-SP) score
timeFrame: End of study (up to 2 years)
measure: Functional Assessment of Cancer Therapy - Brain (FACT-Br) score
timeFrame: End of study (up to 2 years)
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Benjamin Cooper, MD
role: PRINCIPAL_INVESTIGATOR
References: