Actively Recruiting
PrOton Pulsed reduCed dOse Rate Radiotherapy for Recurrent CNS maligNancies Trial
Led by Baptist Health South Florida · Updated on 2025-06-27
28
Participants Needed
2
Research Sites
213 weeks
Total Duration
On this page
Sponsors
B
Baptist Health South Florida
Lead Sponsor
I
Ion Beam Applications
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
PrOton Pulsed reduCed dOse Rate Radiotherapy for Recurrent CNS maligNancies Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Karnofsky performance status of 50 or higher
- Confirmed recurrent or progressive glioma by biopsy or imaging
- Prior radiotherapy treatment of at least 45 Gy
- At least 6 months passed since prior radiotherapy, or meeting specific exceptions for shorter intervals
- Recovery from severe (grade 3 or higher) toxicities of prior therapy
- Not pregnant or breastfeeding and agreement to use effective contraception during treatment and for 6 months after
- Use of highly effective contraception methods unless specific exceptions apply, such as being assigned male at birth or menopause criteria
You will not qualify if you...
- More than one prior course of radiotherapy
- Unable to undergo MRI with contrast
- Evidence of cancer spread to the leptomeninges
- Presence of multifocal disease
- Any other condition that increases risk as determined by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Lynn Cancer Institute at Baptist Health, Inc.
Boca Raton, Florida, United States, 33437
Not Yet Recruiting
2
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, United States, 33176
Actively Recruiting
Research Team
R
Robert Press, M.D.
CONTACT
A
Antoinette Pimental
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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