PrOton Pulsed reduCed dOse Rate Radiotherapy for Recurrent CNS maligNancies Trial
NCT06397560 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28
Last updated 2025-06-27
Summary
The purpose of this research study is to see if a specific type of radiation therapy, called "proton pulsed reduced dose rate" or "PRDR radiotherapy" has any benefits at dose levels and number of fractions thought to be acceptable in earlier research studies. The researchers want to find out what effects (good and bad) PRDR has on people with cancer in the brain called a "recurrent high-grade glioma" meaning that it grows fast, can spread quickly, and it has come back or gotten worse after being treated previously.
Conditions
- Glioma
- Glioma, Malignant
- Recurrent Glioma
Interventions
- RADIATION
-
PRDR
Proton pulsed reduced dose rate (PRDR) technique, to a dose of 54 Gy in 30 fractions (treatments) with proton radiotherapy. Treatments will occur once per day on consecutive weekdays.
Sponsors & Collaborators
-
Ion Beam Applications
collaborator INDUSTRY -
Baptist Health South Florida
lead OTHER
Principal Investigators
-
Robert Press, M.D. · Miami Cancer Institute at Baptist Health, Inc.
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-04-30
- Primary Completion
- 2028-09-30
- Completion
- 2029-06-30
Countries
- United States
Study Locations
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