Hippocampal Avoidance in Craniospinal Irradiation for the Treatment of Leptomeningeal Metastases From Breast Cancer or Non-small Cell Lung Cancer
NCT ID: NCT06518057
Last Updated: 2025-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
22 participants
INTERVENTIONAL
2025-03-03
2027-12-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Photon Craniospinal Irradiation for the Treatment of Leptomeningeal Disease Secondary to Breast Cancer or Non-small Cell Lung Cancer
NCT06910761
Hippocampus-Avoidance Whole-Brain Radiation Therapy With Simultaneous Integrated Boost for BMs of NSCLC
NCT06557187
Whole-Brain Radiation Therapy With or Without Hippocampal Avoidance in Limited Stage or Extensive Stage Small Cell Lung Cancer
NCT02635009
Whole Brain Radiotherapy Versus Volumetric Modulated Arc Therapy for Brain Metastases
NCT02220491
Comparing Single vs Multiple Dose Radiation for Cancer Patients With Brain Metastasis and Receiving Immunotherapy
NCT05703269
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Patients undergo proton or photon VMAT CSI with HA over approximately 45 minutes once daily (QD) for 10 days (Monday-Friday) in the absence of unacceptable toxicity. Patients may also undergo computed tomography (CT) or positron emission tomography (PET)/CT during screening. Additionally, patients will undergo additional CT for radiation planning during screening and magnetic resonance imaging (MRI) throughout the trial. Patients may also undergo lumbar puncture (LP) or alternative methods for cerebral spinal fluid (CSF) collection at the discretion of the treating physician and principal investigator throughout the study.
After completion of study treatment, patients are followed up at 3, 6, 9, and 12 months, and then at the time of CNS disease progression, up to 1 year.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment (Proton or Photon VMAT CSI)
Patients undergo proton or photon VMAT CSI with HA over approximately 45 minutes once daily (QD) for 10 days (Monday-Friday) in the absence of unacceptable toxicity. Patients also undergo computed tomography (CT) or positron emission tomography (PET)/CT during screening. Additionally, patients undergo additional CT for radiation planning during screening and magnetic resonance imaging (MRI) throughout the trial. Patients may also undergo lumbar puncture (LP) or alternative methods for cerebral spinal fluid (CSF) collection at the discretion of the treating physician and principal investigator throughout the study.
Biospecimen Collection
Undergo CSF sample collection
Computed Tomography
Undergo PET/CT and/or CT
Electronic Health Record Review
Ancillary studies
Lumbar Puncture
Undergo lumbar puncture
Magnetic Resonance Imaging
Undergo MRI
Positron Emission Tomography
Undergo PET/CT
Proton Beam Craniospinal Irradiation
Undergo proton CSI
Survey Administration
Ancillary studies
Volume Modulated Arc Therapy
Undergo photon VMAT CSI
Hippocampal-Avoidance Craniospinal Irradiation
Undergo HA
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Biospecimen Collection
Undergo CSF sample collection
Computed Tomography
Undergo PET/CT and/or CT
Electronic Health Record Review
Ancillary studies
Lumbar Puncture
Undergo lumbar puncture
Magnetic Resonance Imaging
Undergo MRI
Positron Emission Tomography
Undergo PET/CT
Proton Beam Craniospinal Irradiation
Undergo proton CSI
Survey Administration
Ancillary studies
Volume Modulated Arc Therapy
Undergo photon VMAT CSI
Hippocampal-Avoidance Craniospinal Irradiation
Undergo HA
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients who are candidates for radiation therapy for the treatment of leptomeningeal metastases
* Patients ≥ 18 years old
* Karnofsky performance status (KPS) ≥ 60 or Eastern Cooperative Oncology Group (ECOG) ≥ 2
* The patient is able to provide informed consent
* Hemoglobin \> 8 g/dL
* Absolute neutrophil count \> 1,000/mm
* Platelet count \> 100,000/mm
* Participants born female at birth must either be of non-reproductive potential (i.e. post-menopausal by history \[≥ 60 years old, or with no menses for \> 1 year without an alternative medical cause\], OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum /urine pregnancy test within 3 weeks prior to starting radiation therapy (RT)
* Patients with reproductive potential must agree to practice two highly effective contraceptive methods
Exclusion Criteria
* Patients with extensive systemic disease and without reasonable systemic treatment options
* Patients who are unable to undergo MRI brain and spine with gadolinium contrast
* Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances
* Gross ventricular disease
* Brain metastases within 5 mm of the hippocampal contours not previously treated
* Pregnant or lactating women
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Washington
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Lia M. Halasz
Role: PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of California San Francisco
San Francisco, California, United States
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2024-05661
Identifier Type: REGISTRY
Identifier Source: secondary_id
FHIRB0020569
Identifier Type: OTHER
Identifier Source: secondary_id
RG1124476
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.