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NCT04343573 · ClinicalTrials.gov registry record · Phase 2
Proton Craniospinal Radiation Therapy vs. Partial Photon Radiation Therapy for Leptomeningeal Metastasis From Solid Tumors
A Phase 2 study of Leptomeningeal Metastases, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 102
- Enrollment target
- 7
- Study locations
NCT04343573: Completed Phase 2 study of Leptomeningeal Metastases, sponsored by Memorial Sloan Kettering Cancer Center.
NCT04343573 is a Phase 2 study of Leptomeningeal Metastases that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 102 participants, above the 32-participant average among 3 other Leptomeningeal Metastases trials with a reported enrollment target (219% higher). The trial reports 7 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04343573, a Phase 2 study of Leptomeningeal Metastases, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 102 participants
- Enrollment target
- 7
- Study locations
Study Summary
The investigators are doing this study to find out whether proton craniospinal radiation therapy (proton CSI) or partial photon radiation therapy is more effective at preventing leptomeningeal metastasis from worsening. The proton CSI targets the entire space containing the CSF, brain, and spinal fluid. The partial photon radiation therapy treats only areas where the patient is having symptoms, such as the entire brain or part of the spine. The investigators also want to find out if proton CSI improves the symptoms patients may be experiencing because of the leptomeningeal metastasis. In addition, the investigators will compare the side effects of proton CSI and partial photon therapy. Patients undergoing proton beam RT will receive their treatment at the New York Proton Center in New York, NY. As part of the New York Proton Consortium, MSK has contracted for its faculty to treat patients at the New York Proton Center. If it is unfeasible for patients to get treated at NYPC, patients will have the decision to get treated at ProCure in Summerset, NJ.
Primary Outcome
For Arm A and Arm B, which will be defined as the duration of time from the date of randomization to the time of progression of disease or death, whichever occurs first. The baseline imaging study will be the diagnostic imaging obtained at study entry.
Conditions Studied
Interventions
- OTHER Neurocognitive Assessment
- RADIATION Involved-field Photon Radiation Therapy
- RADIATION Proton Craniospinal Irradiation (CSI)
- OTHER MDASI-BT and MDASI-SP
Study Locations (7)
New York
- Memorial Sloan Kettering Commack (Limited Protocol Activities) - Commack
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) - Harrison
- Memorial Sloan Kettering Cancer Center - New York
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) - Uniondale
New Jersey
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) - Basking Ridge
- Memorial Sloan Kettering Monmouth (Limitedl protocol activities) - Middletown
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) - Montvale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2020-04-10 |
| Est. Completion | 2026-02-25 |
| Phase | Phase 2 |
What the finished NCT04343573 record still lists
NCT04343573 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, above the 32-participant average among 3 other Leptomeningeal Metastases trials with a reported enrollment target (219% higher).
The record links to 1 condition, with Leptomeningeal Metastases appearing as the primary indexed condition, and to 4 interventions - of which Neurocognitive Assessment is the first listed.
NCT04343573 lists 7 locations in 2 states (New York, New Jersey).
Frequently Asked Questions
What is clinical trial NCT04343573 about?
NCT04343573 is a clinical study titled "Proton Craniospinal Radiation Therapy vs. Partial Photon Radiation Therapy for Leptomeningeal Metastasis From Solid Tumors". The investigators are doing this study to find out whether proton craniospinal radiation therapy (proton CSI) or partial photon radiation therapy is more effective at preventing leptomeningeal metastasis from worsening. The proton CSI targets the entire space containing the CSF, brain, and spinal fl...
What is the current status of trial NCT04343573?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 102 participants. The study started on 2020-04-10. Estimated completion is 2026-02-25.
What conditions does trial NCT04343573 study?
This clinical trial studies the following conditions: Leptomeningeal Metastases.
What interventions are being tested in trial NCT04343573?
The interventions under investigation include: Neurocognitive Assessment (OTHER), Involved-field Photon Radiation Therapy (RADIATION), Proton Craniospinal Irradiation (CSI) (RADIATION), MDASI-BT and MDASI-SP (OTHER).
Who is sponsoring clinical trial NCT04343573?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04343573 being conducted?
This trial has 7 study locations across New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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