Study of Proton Radiation to the Brain and Spinal Cord for Patients With Leptomeningeal Metastases
NCT03520504 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2022-12-23
Summary
The purpose of this study is to find the safest and most effective dose for delivering proton beam to the space containing CSF, brain, and spinal cord, in treating leptomeningeal metastases. The researchers think that using proton beam radiation to treat the space containing CSF, brain, and spinal cord, instead of treating only the areas where the metastasized tumor cells are causing symptoms, would improve the treatment of this disease.
Conditions
- Leptomeningeal Metastases
Interventions
- RADIATION
-
Proton craniospinal irradiation (CSI)
Patients will be enrolled to receive 30Gy (RBE) in 3Gy (RBE) or 25Gy (RBE) in 2.5Gy (RBE) fractions course of proton CSI.
Sponsors & Collaborators
-
Memorial Sloan Kettering Cancer Center
lead OTHER
Principal Investigators
-
Daniel Higginson, MD · Memorial Sloan Kettering Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 10 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-04-26
- Primary Completion
- 2022-12-22
- Completion
- 2022-12-22
- FDA Device
- Yes
Countries
- United States
Study Locations
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