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PRDR Radiotherapy for Recurrent Brain Cancer

This study is testing a special type of radiation therapy called "proton pulsed reduced dose rate" (PRDR radiotherapy) for people with recurrent high-grade glioma. This is a type of brain cancer that has come back or gotten worse after previous treatment. Researchers want to see the good and bad effects of PRDR radiotherapy given in 30 daily treatments over several weeks. You might be able to join if you are 18 or older, have a good performance status, and your glioma has returned after at least 6 months since your last radiation treatment. The main goal is to see how long people live without their cancer growing after 3 months. The study plans to enroll 28 participants, but its current status is unclear.

Study design
This study is an interventional study planning to enroll 28 participants. It is testing a specific radiation technique.
What's involved
Participants will receive PRDR radiotherapy once a day on weekdays for 30 treatments.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, progression-free survival, is measured at 3 months.

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NCT06397560

PrOton Pulsed reduCed dOse Rate Radiotherapy for Recurrent CNS maligNancies Trial

Recruiting
NAAges 18+InterventionalTreatment
Baptist Health South Florida
~28 participants
Updated 2026-06-01 on ClinicalTrials.gov
What's tested:PRDR

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-free survival (PFS)
Measured over 3 months

Conditions

Glioma
Glioma, Malignant
Recurrent Glioma

Explore related trials

Glioma

Where it's being run

2 sites across 1 states
Florida2

Study leadership

  • Robert Press, M.D. · PRINCIPAL_INVESTIGATOR · Miami Cancer Institute at Baptist Health, Inc.

Who to contact

Robert Press, M.D.
[email protected]
(786) 596-2000
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Karnofsky performance status ≥ 50
Histologically-confirmed or radiographic evidence of recurrent / progressive glioma
Prior treatment with radiotherapy to a minimum dose of 45 Gy
At least 6 months or greater between completion of prior radiotherapy and enrollment in this study. If prospective participants have not passed an interval of at least 6 months, they may still be eligible if they meet one or more of the following criteria:
Must have recovered from grade 3+ toxicities of prior therapy and there must be a minimum time of 28 days prior to enrollment from the administration of any investigational agent or prior cytotoxic therapy
Must not be pregnant (positive pregnancy test) or breastfeeding. Must agree to use of highly effective contraception during radiotherapy treatment and for an additional 6 months. Should a participant become pregnant or suspect that they are pregnant while participating in this study, they should notify the treating physician immediately.
Male condom plus spermicide
Cap plus spermicide
Diaphragm plus spermicide
Copper T
Progesterone T
Levonorgestrel-releasing intrauterine system (e.g., Mirena®)
Implants
Hormone shot or injection
Combined pill
Mini-pill
Patch
Individuals assigned male at birth
Amenorrhoeic for 1 year or more following cessation of exogenous hormonal treatments
Luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels in the postmenopausal range for individuals under 50
Radiation-induced oophorectomy with last menses \> 1 year ago
Chemotherapy-induced menopause with \>1 year interval since last menses
Surgical sterilization (bilateral oophorectomy or hysterectomy)

Exclusion

Two or more courses of prior radiotherapy
Inability to undergo an MRI with contrast
Leptomeningeal evidence of recurrent disease
Multi-focal disease
Any other condition that may put a participant at higher risk, at the discretion of the investigator.

What this trial measures

  • Progression-free survival (PFS)3 months

    PFS is defined as the duration of time from treatment start to first progressive disease (PD), date of death, or last follow-up date on which the patient was reported alive after proton PRDR reirradiation. Response to treatment will be assessed using Response Assessment in Neuro-Oncology (RANO).