PrOton Pulsed reduCed dOse Rate Radiotherapy for Recurrent CNS maligNancies Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBaptist Health South Florida
About this trial
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.
Eligibility criteria
Qualifiers
Karnofsky performance status ≥ 50
Histologically-confirmed or radiographic evidence of recurrent / progressive glioma
Prior treatment with radiotherapy to a minimum dose of 45 Gy
New areas of tumor outside the original radiotherapy fields as determined by the investigator.
Disqualifiers
Two or more courses of prior radiotherapy
Inability to undergo an MRI with contrast
Leptomeningeal evidence of recurrent disease
Multi-focal disease
Trial design
Treatments tested in this trial
- PRDR
Treatment groups
28 Participants
are divided into 1 treatment groupSponsors and collaborators
Baptist Health South Florida
Lead sponsor
Ion Beam Applications
Collaborator
Source ClinicalTrials.gov