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

NCT ID: NCT06984523

Last Updated: 2025-05-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-14
• Study Completion Date: 2028-05-12

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Linac based Volumetric Arc Therapy (VMAT) CSI

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.

Group Type: EXPERIMENTAL

Varian Eclipse

Intervention Type: 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.

Interventions

Varian Eclipse

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.

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Benjamin Cooper, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYU Langone Health

New York, New York, United States

Countries

United States

Central Contacts

Benjamin Cooper, MD

Role: CONTACT

Benjamin.cooper@nyulangone.org

212-731-5003

Other Identifiers

24-01730

Identifier Type: -

Identifier Source: org_study_id