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Proton Beam Therapy

PRDR Radiotherapy for Recurrent Brain Cancer (POPCORN Trial)

N/A
Waitlist Available
Led By Robert Press, M.D.
Research Sponsored by Baptist Health South Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically-confirmed or radiographic evidence of recurrent/progressive glioma
Prior treatment with radiotherapy to a minimum dose of 45 Gy
Must not have
Multi-focal disease
Two or more courses of prior radiotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to investigate whether a type of radiation therapy called "proton pulsed reduced dose rate" (PRDR) is effective for treating fast-growing brain cancer that has returned or worsened after

Who is the study for?
This trial is for individuals with a fast-growing, recurrent high-grade glioma (a type of brain cancer) that has returned or worsened after previous treatment. Participants should have had prior radiation therapy and be able to undergo MRI scans.
What is being tested?
The study tests 'proton pulsed reduced dose rate' (PRDR) radiotherapy on patients with recurrent brain tumors. It aims to evaluate the effects of PRDR at specific dose levels and session counts based on earlier studies.
What are the potential side effects?
While not explicitly listed, side effects may include typical reactions to radiation such as fatigue, hair loss at the treated site, skin irritation, headaches, nausea, and potential cognitive changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My brain tumor is growing or has come back.
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I have received radiation therapy with a dose of at least 45 Gy.
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I can do most of my daily activities by myself.
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My scans show real cancer growth, not just damage from radiation, and it's been 3 months since my last radiation treatment.
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My cancer has spread to new areas outside the initial treatment zone.
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I have recovered from severe side effects of my last treatment, and it's been over 28 days since I received it.
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My tumor was confirmed by a biopsy or surgery, and it's been over 90 days since I finished radiotherapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer is present in multiple locations.
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I have undergone radiotherapy at least twice.
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My cancer has spread to the lining of my brain and spinal cord.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression-free survival (PFS)
Secondary study objectives
Assessment of symptoms using the MD Anderson Symptom Inventory for Brain Tumors (MDASI-BT)
Grade 3 central nervous system (CNS) toxicities assessed by CTCAE v5.0
Overall survival (OS)
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: PRDR RadiotherapyExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Ion Beam Applications SAUNKNOWN
Baptist Health South FloridaLead Sponsor
52 Previous Clinical Trials
7,971 Total Patients Enrolled
Robert Press, M.D.Principal InvestigatorMiami Cancer Institute at Baptist Health, Inc.
~19 spots leftby Feb 2027
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