Leptomeningeal MetastasisNCT06984523
Study of Craniospinal Irradiation With Linac Based Volumetric Modulated Arc Therapy (VMAT) for Patients With Leptomeningeal Metastasis
A study testing Varian Eclipse in people with Leptomeningeal Metastasis, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leptomeningeal Metastasis
- What is being tested?
- Varian Eclipse
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2025to 12 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 16Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Single-Arm 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).
- Conditions
- Leptomeningeal Metastasis
- Being tested
- Varian Eclipse
- Medical subject headings
- Meningeal Carcinomatosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Varian EclipseRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: Varian Eclipse |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline up to 1 year from end of treatment
Secondary outcomes (7)
Overall survival
Overall survival will be estimated using Kaplan Meier methods for censored data that includes deaths as events.
Measured: From baseline up to 1 year from end of treatment
Time to CNS progression
Time to CNS progression will be analyzed using competing risk methods, considering death and progression from other causes as competing risks.
Measured: From baseline up to 1 year from end of treatment
Rate of cessation of systemic therapy
Measured: 1 year post-treatment
Number of treatment-related adverse events
Measured: End of study (up to 2 years)
M.D. Anderson Symptom Inventory - Brain Tumor (MDASI-BT) score
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.
Measured: End of study (up to 2 years)
M. D. Anderson Symptom Inventory - Spine Tumor (MDASI-SP) score
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.
Measured: End of study (up to 2 years)
Functional Assessment of Cancer Therapy - Brain (FACT-Br) score
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.
Measured: End of study (up to 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start14 May 2025
- Primary completion12 May 2028 (estimated)
- Study completion12 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leptomeningeal MetastasisStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin Cooper, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06984523
- Sponsor's protocol ID
- 24-01730
- Status last verified
- Mar 2026
- First submitted
- 14 May 2025
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Benjamin.cooper@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Single-Arm Study of Craniospinal Irradiation With Linac Based Volumetric Modulated Arc Therapy (VMAT) for Patients With Leptomeningeal Metastasis
- ClinicalTrials.gov ID
- NCT06984523
- Acronym / sponsor ID
- 24-01730
- Conditions
- Leptomeningeal Metastasis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 14 May 2025 (actual)
- Primary completion
- 12 May 2028 (estimated)
- Study completion
- 12 May 2028 (estimated)
- First posted
- 22 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Linac based Volumetric Arc Therapy (VMAT) CSI | Experimental | Radiation: Varian EclipseRadiation 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Varian EclipseVarian 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. | Radiation | Linac based Volumetric Arc Therapy (VMAT) CSI |
Primary outcome
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.
7 secondary outcomes
Overall survival
Time frame: From baseline up to 1 year from end of treatment
Time to CNS progression
Time frame: From baseline up to 1 year from end of treatment
Rate of cessation of systemic therapy
Time frame: 1 year post-treatment
Number of treatment-related adverse events
Time frame: End of study (up to 2 years)
M.D. Anderson Symptom Inventory - Brain Tumor (MDASI-BT) score
Time frame: End of study (up to 2 years)
M. D. Anderson Symptom Inventory - Spine Tumor (MDASI-SP) score
Time frame: End of study (up to 2 years)
Functional Assessment of Cancer Therapy - Brain (FACT-Br) score
Time frame: End of study (up to 2 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Benjamin.cooper@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Cooper, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Varian Eclipse in people with Leptomeningeal Metastasis, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to central nervous system (CNS) progression free survival (time frame: From baseline up to 1 year from end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.