Actively Recruiting
Photon Craniospinal Irradiation for the Treatment of Leptomeningeal Disease Secondary to Breast Cancer or Non-small Cell Lung Cancer
Led by City of Hope Medical Center · Updated on 2025-12-08
35
Participants Needed
2
Research Sites
178 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial 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). Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. CSI (radiation therapy directed at the brain and spinal cord to kill tumor cells) may be able to target all of the areas of possible leptomeningeal tumor spread. Photon-VMAT-CSI may be an effective treatment option for patients with leptomeningeal disease secondary to breast cancer or NSCLC.
CONDITIONS
Official Title
Photon Craniospinal Irradiation for the Treatment of Leptomeningeal Disease Secondary to Breast Cancer or Non-small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided informed consent and assent if appropriate
- Age 18 years or older
- Karnofsky performance status of 60 or higher
- Able to read and understand English or Spanish or use a certified interpreter to complete questionnaires
- Histologically confirmed breast cancer or non-small cell lung cancer
- Leptomeningeal disease confirmed by imaging or cerebrospinal fluid cytology
- Absolute neutrophil count of at least 1,000/mm^3
- Hemoglobin level of at least 8 g/dL
- Platelet count of at least 100,000/mm^3
- Creatinine clearance of 50 mL/min or higher
- Women of childbearing potential must have a negative pregnancy test
- Agreement to use effective birth control or abstain from heterosexual activity during the study and for one month after last treatment
You will not qualify if you...
- Received chemotherapy, biological therapy, or immunotherapy within 7 days before starting study treatment
- Prior radiation that prevents safe craniospinal irradiation
- Severe neurological symptoms such as encephalopathy
- Extensive uncontrolled systemic disease
- No reasonable systemic treatment options
- Other significant uncontrolled illnesses
- History or evidence of HIV infection unless on effective treatment with undetectable viral load
- History or evidence of chronic hepatitis B unless on suppressive therapy with undetectable viral load
- History or evidence of hepatitis C unless cured or on treatment with undetectable viral load
- Active other cancers that could interfere with study safety or results
- Pregnant or breastfeeding women
- Unable to undergo MRI with gadolinium contrast
- Any condition that would make participation unsafe or prevent compliance with study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
2
City of Hope at Irvine Lennar
Irvine, California, United States, 92618
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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