PrOton Pulsed reduCed dOse Rate Radiotherapy for Recurrent CNS maligNancies Trial
POPCORN
1 other identifier
interventional
28
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2025
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2024
CompletedFirst Posted
Study publicly available on registry
May 3, 2024
CompletedStudy Start
First participant enrolled
April 30, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2029
June 27, 2025
March 1, 2025
3.3 years
April 30, 2024
June 24, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free survival (PFS)
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).
3 months
Secondary Outcomes (5)
Treatment-related adverse events (AEs) assessed by Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0)
2 years
Overall survival (OS)
2 years
Grade 3 central nervous system (CNS) toxicities assessed by CTCAE v5.0
2 years
Assessment of symptoms using the MD Anderson Symptom Inventory for Brain Tumors (MDASI-BT)
1 year
Quality of life (QOL) assessed by the EuroQOL 5-dimension, 5-level (EQ-5D-5L)
1 year
Study Arms (1)
PRDR Radiotherapy
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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:
- New areas of tumor outside the original radiotherapy fields as determined by the investigator.
- Histologic confirmation of tumor through biopsy or resection AND an interval of at least 90 days between completion of radiotherapy and enrollment.
- Nuclear medicine imaging, magnetic resonance (MR) spectroscopy, or MR perfusion imaging consistent with true progressive disease, rather than radiation necrosis obtained within 28 days of enrollment AND an interval of at least 90 days between completion of radiotherapy and enrollment.
- 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.
- Highly effective and acceptable forms of contraception are:
- Male condom plus spermicide
- Cap plus spermicide
- Diaphragm plus spermicide
- Copper T
- Progesterone T
- +13 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Baptist Health South Floridalead
- Ion Beam Applicationscollaborator
Study Sites (2)
Lynn Cancer Institute at Baptist Health, Inc.
Boca Raton, Florida, 33437, United States
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, 33176, United States
Related Publications (6)
Adkison JB, Tome W, Seo S, Richards GM, Robins HI, Rassmussen K, Welsh JS, Mahler PA, Howard SP. Reirradiation of large-volume recurrent glioma with pulsed reduced-dose-rate radiotherapy. Int J Radiat Oncol Biol Phys. 2011 Mar 1;79(3):835-41. doi: 10.1016/j.ijrobp.2009.11.058. Epub 2010 May 14.
PMID: 20472350BACKGROUNDBovi JA, Prah MA, Retzlaff AA, Schmainda KM, Connelly JM, Rand SD, Marszalkowski CS, Mueller WM, Siker ML, Schultz CJ. Pulsed Reduced Dose Rate Radiotherapy in Conjunction With Bevacizumab or Bevacizumab Alone in Recurrent High-grade Glioma: Survival Outcomes. Int J Radiat Oncol Biol Phys. 2020 Nov 15;108(4):979-986. doi: 10.1016/j.ijrobp.2020.06.020. Epub 2020 Jun 27.
PMID: 32599030BACKGROUNDDilworth JT, Krueger SA, Dabjan M, Grills IS, Torma J, Wilson GD, Marples B. Pulsed low-dose irradiation of orthotopic glioblastoma multiforme (GBM) in a pre-clinical model: effects on vascularization and tumor control. Radiother Oncol. 2013 Jul;108(1):149-54. doi: 10.1016/j.radonc.2013.05.022. Epub 2013 Jun 19.
PMID: 23791366BACKGROUNDKotecha R, Odia Y, Khosla AA, Ahluwalia MS. Key Clinical Principles in the Management of Glioblastoma. JCO Oncol Pract. 2023 Apr;19(4):180-189. doi: 10.1200/OP.22.00476. Epub 2023 Jan 13.
PMID: 36638331BACKGROUNDKutuk T, Tolakanahalli R, McAllister NC, Hall MD, Tom MC, Rubens M, Appel H, Gutierrez AN, Odia Y, Mohler A, Ahluwalia MS, Mehta MP, Kotecha R. Pulsed-Reduced Dose Rate (PRDR) Radiotherapy for Recurrent Primary Central Nervous System Malignancies: Dosimetric and Clinical Results. Cancers (Basel). 2022 Jun 15;14(12):2946. doi: 10.3390/cancers14122946.
PMID: 35740612BACKGROUNDSaeed AM, Khairnar R, Sharma AM, Larson GL, Tsai HK, Wang CJ, Halasz LM, Chinnaiyan P, Vargas CE, Mishra MV. Clinical Outcomes in Patients with Recurrent Glioblastoma Treated with Proton Beam Therapy Reirradiation: Analysis of the Multi-Institutional Proton Collaborative Group Registry. Adv Radiat Oncol. 2020 Apr 22;5(5):978-983. doi: 10.1016/j.adro.2020.03.022. eCollection 2020 Sep-Oct.
PMID: 33083661BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Press, M.D.
Miami Cancer Institute at Baptist Health, Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2024
First Posted
May 3, 2024
Study Start
April 30, 2025
Primary Completion (Estimated)
September 1, 2028
Study Completion (Estimated)
June 1, 2029
Last Updated
June 27, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share