NCT06910761 · City of Hope Medical Center
Photon Craniospinal Irradiation for the Treatment of Leptomeningeal Disease Secondary to Breast Cancer or Non-small Cell Lung Cancer
What this study is about
This phase II trial tests how well craniospinal irradiation (CSI) using photon volumetric modulated arc radiotherapy (VMAT) works in treating patients with breast cancer or non-small cell lung cancer (NSCLC) that has spread from the original (primary) tumor to the cerebrospinal fluid and meninges (thin layers of tissue that cover and protect the brain and spinal cord) (leptomeningeal disease).
View original scientific description
This phase II trial tests how well craniospinal irradiation (CSI) using photon volumetric modulated arc radiotherapy (VMAT) works in treating patients with breast cancer or non-small cell lung cancer (NSCLC) that has spread from the original (primary) tumor to the cerebrospinal fluid and meninges (thin layers of tissue that cover and protect the brain and spinal cord) (leptomeningeal disease).
Interventions
PROCEDURE
Biospecimen Collection
Undergo blood and CSF sample collection
RADIATION
Craniospinal Irradiation
Undergo photon-VMAT-CSI
OTHER
Electronic Health Record Review
Ancillary studies
PROCEDURE
Lumbar Puncture
Undergo LP
PROCEDURE
Magnetic Resonance Imaging
Undergo MRI
PROCEDURE
Ommaya Reservoir Tap
Undergo Ommaya reservoir tap
OTHER
Questionnaire Administration
Ancillary studies
RADIATION
Volume Modulated Arc Therapy
Undergo photon-VMAT-CSI
Primary outcome measures
Central nervous system (CNS)-progression free survival
Time frame: From 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Documented informed consent of the participant and/or legally authorized representative
- Assent, when appropriate, will be obtained per institutional guidelines
- 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 criteria
- 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)
Where
- Duarte, California
- Irvine, California
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 8, 2025 · Source of record for eligibility and locations