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NCT06518057 · ClinicalTrials.gov registry record · Phase 2
Hippocampal Avoidance in Craniospinal Irradiation for the Treatment of Leptomeningeal Metastases From Breast Cancer or Non-small Cell Lung Cancer
A Phase 2 study of Stage IV Lung Cancer AJCC v8 and Anatomic Stage IV Breast Cancer AJCC v8, sponsored by University of Washington.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
- 2
- Study locations
NCT06518057: Recruiting Phase 2 study of Stage IV Lung Cancer AJCC v8 and Anatomic Stage IV Breast Cancer AJCC v8, sponsored by University of Washington.
NCT06518057 is a Phase 2 study of Stage IV Lung Cancer AJCC v8 and Anatomic Stage IV Breast Cancer AJCC v8 that is actively recruiting participants, run by University of Washington. The registered enrollment target is 22 participants, below the 98-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (78% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06518057, a Phase 2 study of Stage IV Lung Cancer AJCC v8 and Anatomic Stage IV Breast Cancer AJCC v8, is actively recruiting participants, sponsored by University of Washington.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
PFS is defined as time from craniospinal irradiation (CSI) to CNS disease progression or death. CNS-PFS will be summarized using Kaplan-Meier methodology. Median, 95% confidence interval (CI) and Kaplan-Meier plot will be provided. One-sample log-rank test will be used to test if the median CNS PFS of hippocampal avoidance in CSI for leptomeningeal metastases from breast cancer or non-small cell lung cancer (NSCLC) is significantly larger than the expected median CNS PFS with involved-field radi
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Lumbar Puncture
- PROCEDURE Magnetic Resonance Imaging
- OTHER Electronic Health Record Review
Study Locations (2)
California
- University of California San Francisco - San Francisco
Washington
- Fred Hutch/University of Washington Cancer Consortium - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2025-03-03 |
| Est. Completion | 2027-12-30 |
| Phase | Phase 2 |
What NCT06518057 shows while recruiting
NCT06518057 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 98-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (78% lower).
The record links to 5 conditions, with Stage IV Lung Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06518057 reports a single indexed study location in California, Washington.
Frequently Asked Questions
What is clinical trial NCT06518057 about?
NCT06518057 is a clinical study titled "Hippocampal Avoidance in Craniospinal Irradiation for the Treatment of Leptomeningeal Metastases From Breast Cancer or Non-small Cell Lung Cancer". 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) tu...
What is the current status of trial NCT06518057?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2025-03-03. Estimated completion is 2027-12-30.
What conditions does trial NCT06518057 study?
This clinical trial studies the following conditions: Stage IV Lung Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Lung Non-Small Cell Carcinoma, Metastatic Breast Carcinoma, Metastatic Malignant Neoplasm in the Leptomeninges.
What interventions are being tested in trial NCT06518057?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Lumbar Puncture (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Electronic Health Record Review (OTHER).
Who is sponsoring clinical trial NCT06518057?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06518057 being conducted?
This trial has 2 study locations across California, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06518057's enrollment target sits among peer trials
22 61st of 81 higher than 18 of 81 other Stage IV Lung Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage IV Lung Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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