Photon Craniospinal Irradiation for Leptomeningeal Disease
This study is testing a type of radiation therapy called photon-VMAT-CSI (Craniospinal Irradiation using photon volumetric modulated arc radiotherapy) for patients with breast cancer or non-small cell lung cancer that has spread to the brain and spinal cord lining (leptomeningeal disease). The goal is to see how well this treatment prevents the cancer from growing in the central nervous system (CNS). Researchers will also look at side effects, quality of life, and other markers in the body. About 35 people will participate. This study is currently recruiting, but the exact status is unclear. You may be eligible if you are 18 or older and have a good performance status.
- Study design
- This is an interventional study with a planned enrollment of 35 participants. It is a single-arm study, meaning all participants receive the same treatment.
- What's involved
- You would undergo blood and spinal fluid (CSF) sample collection, lumbar punctures, and MRI scans. You would receive photon-VMAT-CSI radiation therapy daily for 10 treatments over 10-20 days.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your central nervous system progression will be assessed for up to 1 year after starting treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06910761
Photon Craniospinal Irradiation for the Treatment of Leptomeningeal Disease Secondary to Breast Cancer or Non-small Cell Lung Cancer
Recruiting
PHASE2Ages 18+InterventionalTreatmentCity of Hope Medical CenterInvestigator-initiated
~35 participants
Updated 2025-12-08 on ClinicalTrials.gov
What's tested:Biospecimen CollectionCraniospinal IrradiationElectronic Health Record ReviewLumbar PunctureMagnetic Resonance ImagingOmmaya Reservoir Tap
At a glance
Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Central nervous system (CNS)-progression free survival
Measured over From start of treatment to CNS relapse, CNS progression, death (from any cause), or last contact, whichever occurs first, assessed up to 1 year
Conditions
Where it's being run
2 sites across 1 statesCalifornia2
Study leadership
- Stephanie M Yoon · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Documented informed consent of the participant and/or legally authorized representative
Assent, when appropriate, will be obtained per institutional guidelines
≥ 18 years
Karnofsky performance status (KPS) ≥ 60
Ability to read and understand English or Spanish for questionnaires, or ability to complete questionnaires using certified interpreter
Histologically confirmed breast cancer or non-small cell lung cancer
Leptomeningeal disease established either radiographically and/or CSF cytology
Absolute neutrophil count (ANC) ≥ 1,000/mm\^3
Hemoglobin ≥ 8 g/dL
Platelet ≥ 100,000/mm\^3
Creatinine clearance of ≥ 50 mL/min per 24 hour urine test or the Cockcroft-Gault formula
Women of childbearing potential (WOCBP): negative urine or serum pregnancy test
If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 1 month after the last dose of protocol therapy
Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)
Exclusion
Chemotherapy, biological therapy, immunotherapy within 7 days prior to day 1 of protocol therapy
Any prior radiation that in the opinion of the investigator unable to respect normal tissue tolerances and preclude craniospinal irradiation
Patients with multiple or serious major neurologic symptoms (including encephalopathy) per physician / investigator assessment
Patients with extensive, uncontrolled extracranial systemic disease
Patients without reasonable systemic treatment options per physician / investigator
Other clinically significant uncontrolled illness per opinion of physician / investigator
Patients with a history or evidence of HIV infection (unless on effective anti-retroviral therapy with undetectable viral load based on prior tests within 6 months are eligible for this trial)
Patients with history or evidence of chronic hepatitis B virus (HBV) infection (unless HBV viral load is undetectable based on prior tests and on suppressive therapy)
Patients with a history or evidence of hepatitis C virus (HCV) infection unless treated and cured. (Patients with HCV infection who are currently on treatment are eligible if they have an undetectable HCV viral load based on prior tests)
Other active malignancy. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the study are eligible for this trial
Females only: Pregnant or breastfeeding
Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
Unable to undergo MRI brain and spine with gadolinium contrast
Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
What this trial measures
- Central nervous system (CNS)-progression free survivalFrom start of treatment to CNS relapse, CNS progression, death (from any cause), or last contact, whichever occurs first, assessed up to 1 year
Will be estimated using the Kaplan-Meier estimator, and its associating 95% confidence limit will be calculated using the logit transformation and the Greenwood variance estimate.