Trial Title:
Hippocampal Avoidance in Craniospinal Irradiation for the Treatment of Leptomeningeal Metastases From Breast Cancer or Non-small Cell Lung Cancer
NCT ID:
NCT06518057
Condition:
Anatomic Stage IV Breast Cancer AJCC v8
Metastatic Breast Carcinoma
Metastatic Lung Non-Small Cell Carcinoma
Metastatic Malignant Neoplasm in the Leptomeninges
Stage IV Lung Cancer AJCC v8
Conditions: Official terms:
Carcinoma
Breast Neoplasms
Lung Neoplasms
Neoplasms
Carcinoma, Non-Small-Cell Lung
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo CSF sample collection
Arm group label:
Treatment (Proton or Photon VMAT CSI)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo PET/CT and/or CT
Arm group label:
Treatment (Proton or Photon VMAT CSI)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized axial tomography (procedure)
Other name:
Computerized Tomography
Other name:
Computerized Tomography (CT) scan
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Other
Intervention name:
Electronic Health Record Review
Description:
Ancillary studies
Arm group label:
Treatment (Proton or Photon VMAT CSI)
Intervention type:
Procedure
Intervention name:
Lumbar Puncture
Description:
Undergo lumbar puncture
Arm group label:
Treatment (Proton or Photon VMAT CSI)
Other name:
LP
Other name:
Spinal Tap
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging
Description:
Undergo MRI
Arm group label:
Treatment (Proton or Photon VMAT CSI)
Other name:
Magnetic Resonance
Other name:
Magnetic Resonance Imaging (MRI)
Other name:
Magnetic resonance imaging (procedure)
Other name:
Magnetic Resonance Imaging Scan
Other name:
Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
Other name:
MR
Other name:
MR Imaging
Other name:
MRI
Other name:
MRI Scan
Other name:
MRIs
Other name:
NMR Imaging
Other name:
NMRI
Other name:
Nuclear Magnetic Resonance Imaging
Other name:
sMRI
Other name:
Structural MRI
Intervention type:
Procedure
Intervention name:
Positron Emission Tomography
Description:
Undergo PET/CT
Arm group label:
Treatment (Proton or Photon VMAT CSI)
Other name:
Medical Imaging, Positron Emission Tomography
Other name:
PET
Other name:
PET Scan
Other name:
Positron emission tomography (procedure)
Other name:
Positron Emission Tomography Scan
Other name:
Positron-Emission Tomography
Other name:
proton magnetic resonance spectroscopic imaging
Other name:
PT
Intervention type:
Radiation
Intervention name:
Proton Beam Craniospinal Irradiation
Description:
Undergo proton CSI
Arm group label:
Treatment (Proton or Photon VMAT CSI)
Other name:
Craniospinal Proton Beam Radiation Therapy
Other name:
p-CSI
Other name:
Proton Craniospinal Irradiation
Other name:
Proton Craniospinal Radiation Therapy
Intervention type:
Other
Intervention name:
Survey Administration
Description:
Ancillary studies
Arm group label:
Treatment (Proton or Photon VMAT CSI)
Intervention type:
Radiation
Intervention name:
Volume Modulated Arc Therapy
Description:
Undergo photon VMAT CSI
Arm group label:
Treatment (Proton or Photon VMAT CSI)
Other name:
VMAT
Other name:
Volumetric Modulated Arc Therapy (procedure)
Summary:
This phase II clinical trial studies how well craniospinal irradiation (CSI) with
hippocampal avoidance, using proton therapy or volumetric modulated arc therapy (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 (CSF) and
meninges (thin layers of tissue that cover and protect the brain and spinal cord)
(leptomeningeal metastases). Radiation therapy is an effective treatment in relieving
localized symptoms caused by leptomeningeal metastases. However, the type of radiation
therapy typically used does not prevent the spread of leptomeningeal disease. 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. CSI may however
result in significant neurological side effects due to radiation damage to a part of the
brain called the hippocampus. Hippocampal avoidance (HA) reduces the amount of radiation
to the hippocampus. Proton or VMAT CSI with HA may be an effective treatment while
reducing neurological side effects for patients with leptomeningeal metastases from
breast cancer and NSCLC.
Detailed description:
OUTLINE:
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, as well as additional CT for radiation planning during screening.
Additionally, patients undergo magnetic resonance imaging (MRI) throughout the trial.
They may also undergo lumbar puncture (LP) or alternative methods for cerebral spinal
fluid (CSF) collection.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients with breast cancer or NSCLC malignancies with leptomeningeal metastases
established radiographically and/or through CSF cytology
- Patients who are candidates for radiation therapy for the treatment of
leptomeningeal metastases
- Patients ≥ 18 years old
- Karnofsky performance status (KPS) ≥ 60
- The patient/legally authorized representative 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
pregnancy test within 2 weeks prior to starting treatment
- Patients with reproductive potential must agree to practice an effective
contraceptive method
Exclusion Criteria:
- Patients with multiple, serious major neurologic deficits per physician/investigator
assessment including encephalopathy
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fred Hutch/University of Washington Cancer Consortium
Address:
City:
Seattle
Zip:
98109
Country:
United States
Contact:
Last name:
Lia M. Halasz
Phone:
206-897-2121
Email:
lhalasz@uw.edu
Investigator:
Last name:
Lia M. Halasz
Email:
Principal Investigator
Start date:
December 1, 2024
Completion date:
June 30, 2027
Lead sponsor:
Agency:
University of Washington
Agency class:
Other
Source:
University of Washington
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06518057
