Reirradiation of large-volume recurrent glioma with pulsed reduced-dose-rate radiotherapy.
Jarrod B Adkison, Wolfgang Tomé, Songwon Seo...
https://pubmed.ncbi.nlm.nih.gov/20472350Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06397560
PrOton Pulsed reduCed dOse Rate Radiotherapy for Recurrent CNS maligNancies (POPCORN) Trial
Led by Baptist Health South Florida · Updated on 2026-06-01
28
Participants Needed
2
Research Sites
39 weeks
Total Duration
On this page
Sponsors
B
Baptist Health South Florida
Lead Sponsor
I
Ion Beam Applications
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the effects of a special type of radiation therapy called proton pulsed reduced dose rate (PRDR) radiotherapy in people with recurrent high-grade glioma, a fast-growing and returning brain cancer. The study aims to understand both the benefits and side effects of PRDR at dose levels found acceptable in earlier studies. This research focuses on patients whose cancer has come back or worsened after previous treatment. Participants will receive PRDR radiotherapy using proton beams, delivering a total dose of 54 Gy divided into 30 treatment sessions. These sessions occur once a day on consecutive weekdays. The study does not mention any comparison groups or placebo treatments. The treatment phase is planned to follow a specific schedule to assess the therapy's impact. During the study, participants will undergo regular assessments to monitor cancer progression, symptoms, side effects, and quality of life. Researchers will use tools like the MD Anderson Symptom Inventory for Brain Tumors and the EuroQOL quality of life questionnaire. Safety will be tracked over two years, including serious brain-related side effects. The main outcome measured is progression-free survival at three months. The study starts in April 2025 and continues through June 2029, involving careful follow-up to evaluate treatment results and patient well-being.
CONDITIONS
Brief Title
PrOton Pulsed reduCed dOse Rate Radiotherapy for Recurrent CNS maligNancies Trial
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Karnofsky performance status of 50 or higher
- Histologically-confirmed or radiographic evidence of recurrent or progressive glioma
- Prior radiotherapy of at least 45 Gy
- At least 6 months since completion of prior radiotherapy, or meeting specific criteria if less than 6 months have passed
- Recovery from grade 3 or higher toxicities of previous therapy
- Not pregnant or breastfeeding and agreement to use highly effective contraception during treatment and for 6 months after
- Individuals not requiring contraception include those assigned male at birth, those amenorrhoeic for over 1 year after stopping hormones, those with postmenopausal hormone levels under 50, or those with surgical sterilization
You will not qualify if you...
- Two or more courses of prior radiotherapy
- Unable to undergo MRI with contrast
- Leptomeningeal evidence of recurrent disease
- Multifocal disease
- Any condition increasing risk as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Approximately 6 weeks (30 treatment days)
Participants receive proton pulsed reduced dose rate radiotherapy with a dose of 54 Gy in 30 daily fractions on consecutive weekdays.
Daily visits on weekdays for treatment
Trial Site Locations
Total: 2 locations
1
Lynn Cancer Institute at Baptist Health, Inc.
Boca Raton, Florida, United States, 33437
Not Yet Recruiting
2
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, United States, 33176
Actively Recruiting
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Research Team
R
Robert Press, M.D.
K
Kristy Reyes
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Pulsed Reduced Dose Rate Radiotherapy in Conjunction With Bevacizumab or Bevacizumab Alone in Recurrent High-grade Glioma: Survival Outcomes.
Joseph A Bovi, Melissa A Prah, Amber A Retzlaff...
https://pubmed.ncbi.nlm.nih.gov/32599030Pulsed low-dose irradiation of orthotopic glioblastoma multiforme (GBM) in a pre-clinical model: effects on vascularization and tumor control.
Joshua T Dilworth, Sarah A Krueger, Mohamad Dabjan...
https://pubmed.ncbi.nlm.nih.gov/23791366Key Clinical Principles in the Management of Glioblastoma.
Rupesh Kotecha, Yazmin Odia, Atulya A Khosla...
https://pubmed.ncbi.nlm.nih.gov/36638331Pulsed-Reduced Dose Rate (PRDR) Radiotherapy for Recurrent Primary Central Nervous System Malignancies: Dosimetric and Clinical Results.
Tugce Kutuk, Ranjini Tolakanahalli, Nicole C McAllister...
https://pubmed.ncbi.nlm.nih.gov/35740612Clinical Outcomes in Patients with Recurrent Glioblastoma Treated with Proton Beam Therapy Reirradiation: Analysis of the Multi-Institutional Proton Collaborative Group Registry.
Ali M Saeed, Rahul Khairnar, Ankur M Sharma...
https://pubmed.ncbi.nlm.nih.gov/33083661