PrOton Pulsed reduCed dOse Rate Radiotherapy for Recurrent CNS maligNancies Trial
Part of paid clinical trials in Boca Raton, Florida.
- Sponsor
- Baptist Health South Florida
- Study ID
- NCT06397560
- Status
- Recruiting
Conditions
- Glioma
- Glioma, Malignant
- Recurrent Glioma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- PRDR — RADIATIONProton 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.
Study Details
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.
Key Dates
- Start date
- Apr 30, 2025
- Status verified
- May 2026
- Primary completion
- Sep 30, 2028
- Completion
- Jun 30, 2029
Study Design
- Enrollment
- 28 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: PRDR Radiotherapy
Primary Outcome Measure
Progression-free survival (PFS) [ Time Frame: 3 months ]
Central Contacts
- Robert Press, M.D.(786) 596-2000
- Kristy Reyes(786) 596-2000
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Lynn Cancer Institute at Baptist Health, Inc. | Boca Raton | Florida | 33437 | |
| Miami Cancer Institute at Baptist Health, Inc. | Miami | Florida | 33176 | Rupesh Kotecha, M.D. (SUB_INVESTIGATOR) Robert Press, M.D. (PRINCIPAL_INVESTIGATOR) |
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