Ignite Creation Date:
2024-10-25 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06518057
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
Hippocampal Avoidance in Craniospinal Irradiation for the Treatment of Leptomeningeal Metastases From Breast Cancer or Non-small Cell Lung Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multi-Center Phase 2 Study of Hippocampal Avoidance in Craniospinal Irradiation for Leptomeningeal Metastases From Solid Tumors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 PETCT 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
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 PETCT 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None