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

NYU Langone Health

Status: Not yet enrolling

Conditions: Leptomeningeal Metastasis

Treatments: Radiation: Varian Eclipse

Study type: Interventional

Funder types: Other

Identifiers

NCT06984523

24-01730

Details and patient eligibility

About

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).

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Linac based Volumetric Arc Therapy (VMAT) CSI

Experimental group

Description:

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.

Treatment:

Radiation: Varian Eclipse