GliomaPOPCORNNCT06397560
PrOton Pulsed reduCed dOse Rate Radiotherapy for Recurrent CNS maligNancies Trial
A study testing PRDR in people with Glioma and Glioma, Malignant, run by Baptist Health South Florida at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma, Glioma, Malignant, Recurrent Glioma
- What is being tested?
- PRDR
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Apr 2025to Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 28Show fewer
- 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
- Levonorgestrel-releasing intrauterine system (e.g., Mirena®)
- Implants
- Hormone shot or injection
- Combined pill
- Mini-pill
- Patch
- Individuals who meet any of the following criteria will not need contraception:
- 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)
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
Lynn Cancer Institute at Baptist Health, Inc.
Boca Raton, Florida, 33437
Hina Saeed, M.D., 561-374-5440, Hina.Saeed@baptisthealth.net
- Recruiting
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, 33176
Robert Press, M.D., 786-596-2000, Robert.Press@baptisthealth.net
Kristy Reyes, (786) 596-2000, Kristina.Reyes@baptisthealth.net
About this study
Official title: PrOton Pulsed reduCed dOse Rate Radiotherapy for Recurrent CNS maligNancies (POPCORN) 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.
- Conditions
- Glioma, Glioma, Malignant, Recurrent Glioma
- Being tested
- PRDR
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRDRRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| PRDR Radiotherapy | Experimental | Not described Receives: Radiation: PRDR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 months
Secondary outcomes (5)
Treatment-related adverse events (AEs) assessed by Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0)
The total number of AEs considered possibly, probably, or definitely related to proton PRDR as per the CTCAE v5.0.
Measured: 2 years
Overall survival (OS)
OS is defined as the duration of time from treatment start to date of death, or last follow-up date on which the patient was reported alive after proton PRDR reirradiation.
Measured: 2 years
Grade 3 central nervous system (CNS) toxicities assessed by CTCAE v5.0
The number of CNS AEs considered possibly, probably, or definitely related to proton PRDR as per CTCAE v5.0
Measured: 2 years
Assessment of symptoms using the MD Anderson Symptom Inventory for Brain Tumors (MDASI-BT)
Symptoms will be assessed using the MDASI-BT, which is a 28-item questionnaire that asks about cancer symptoms and how the symptoms interfere with daily life. Each item is scored on a 0-10 scale (0 = best, 10 = worst), with a total score of 0-280, with a higher score indicating worse symptoms.
Measured: 1 year
Quality of life (QOL) assessed by the EuroQOL 5-dimension, 5-level (EQ-5D-5L)
QOL will be assessed using the EQ-5D-5L questionnaire. There are five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. There also is a visual analog scale asking about overall health that ranges from 0-100. Higher scores indicate better health and QOL.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start30 Apr 2025
- Primary completionSep 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for GliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baptist Health South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Ion Beam Applications
- Responsible party
- Sponsor
- Investigators
- Robert Press, M.D., Principal investigator, Miami Cancer Institute at Baptist Health, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06397560
- Sponsor's protocol ID
- 2022-KOT-001
- Acronym
- POPCORN
- Status last verified
- May 2026
- First submitted
- 30 Apr 2024
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20472350Bovi 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.
PubMed 32599030Dilworth 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.
PubMed 23791366Kotecha 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.
PubMed 36638331Kutuk 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.
PubMed 35740612Saeed 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.
PubMed 33083661
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PrOton Pulsed reduCed dOse Rate Radiotherapy for Recurrent CNS maligNancies (POPCORN) Trial
- ClinicalTrials.gov ID
- NCT06397560
- Acronym / sponsor ID
- POPCORN / 2022-KOT-001
- Conditions
- Glioma, Glioma, Malignant, Recurrent Glioma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Baptist Health South FloridaUniversity, hospital or other
- Collaborators
- Ion Beam Applications
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 3 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PRDR Radiotherapy | Experimental | Radiation: PRDR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRDRProton 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. | Radiation | PRDR Radiotherapy |
Primary outcome
Progression-free survival (PFS)
Time frame: 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).
5 secondary outcomes
Treatment-related adverse events (AEs) assessed by Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0)
Time frame: 2 years
Overall survival (OS)
Time frame: 2 years
Grade 3 central nervous system (CNS) toxicities assessed by CTCAE v5.0
Time frame: 2 years
Assessment of symptoms using the MD Anderson Symptom Inventory for Brain Tumors (MDASI-BT)
Time frame: 1 year
Quality of life (QOL) assessed by the EuroQOL 5-dimension, 5-level (EQ-5D-5L)
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Background: PubMed 20472350Adkison 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.
- Background: PubMed 32599030Bovi 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.
- Background: PubMed 23791366Dilworth 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.
- Background: PubMed 36638331Kotecha 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.
- Background: PubMed 35740612Kutuk 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.
- Background: PubMed 33083661Saeed 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.
- Baptist Health Cancer CareLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert Press, M.D. principal investigator
Miami Cancer Institute at Baptist Health, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRDR in people with Glioma and Glioma, Malignant, run by Baptist Health South Florida at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 28 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robert Press, M.D. ((786) 596-2000, Robert.Press@baptisthealth.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06397560, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.