Clinical trial · Interventional
Study of Craniospinal Irradiation With Linac Based Volumetric Modulated Arc Therapy (VMAT) for Patients With Leptomeningeal Metastasis
A Phase II Single-Arm Study of Craniospinal Irradiation With Linac Based Volumetric Modulated Arc Therapy (VMAT) for Patients With Leptomeningeal Metastasis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leptomeningeal Metastasis | Meningeal Carcinomatosis | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Varian Eclipse | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Linac based Volumetric Arc Therapy (VMAT) CSI
- 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.
- interventionNames
- Radiation: Varian Eclipse
Primary outcomes (1)
- measure
- Time to central nervous system (CNS) progression free survival
- timeFrame
- From baseline up to 1 year from end of treatment
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available