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 — RADIATION
    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.

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

Locations (2)

FacilityCityStateZIPSite coordinators
Lynn Cancer Institute at Baptist Health, Inc.Boca RatonFlorida33437
Hina Saeed, M.D.
561-374-5440
Miami Cancer Institute at Baptist Health, Inc.MiamiFlorida33176
Robert Press, M.D.
786-596-2000
Kristy Reyes
(786) 596-2000
Rupesh Kotecha, M.D. (SUB_INVESTIGATOR)
Robert Press, M.D. (PRINCIPAL_INVESTIGATOR)

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