PRDR Radiotherapy for Recurrent Brain Cancer

(POPCORN Trial)

Recruiting at 1 trial location

Overseen By Robert Press, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Baptist Health South Florida

Disqualifiers: Two prior radiotherapy, MRI inability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

28 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new type of radiation therapy called PRDR to determine its effectiveness for people with recurring brain cancer, specifically high-grade glioma. Researchers aim to understand both the benefits and potential side effects of this treatment. The study targets individuals whose brain cancer has returned after previous treatments and who have undergone radiation therapy no more than once. Participants must have recovered from major side effects of past treatments and cannot be pregnant or breastfeeding. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could lead to new treatment options for brain cancer.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, you must have recovered from severe side effects of previous treatments and wait at least 28 days after any investigational or cytotoxic therapy before enrolling.

What prior data suggests that PRDR radiotherapy is safe for recurrent brain cancer?

Research has shown that PRDR (pulsed reduced dose rate) radiotherapy is generally safe and well-tolerated. Studies have found it effective for treating recurring brain tumors, with manageable side effects. Patients who received PRDR treatment reported good survival rates, suggesting it could be a viable option for those with recurring high-grade gliomas. PRDR has also been used for other brain and nervous system tumors, as well as certain cancers like breast and head and neck cancers, with low toxicity levels. This indicates the treatment usually doesn't cause severe side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard radiotherapy options for recurrent brain cancer, PRDR (Pulsed Reduced Dose Rate) Radiotherapy offers a unique approach by delivering radiation in smaller, more frequent doses over an extended period. This method is thought to minimize damage to healthy brain tissue while maintaining its effectiveness against cancer cells. Researchers are excited about PRDR because it has the potential to improve outcomes for patients with recurrent brain cancer by reducing side effects and potentially enhancing the overall quality of life compared to traditional radiotherapy methods.

What evidence suggests that PRDR radiotherapy might be an effective treatment for recurrent high-grade glioma?

Studies have shown that PRDR radiotherapy, which participants in this trial will receive, can effectively treat recurrent high-grade gliomas, fast-growing brain cancers. In some research, 36% of patients showed improvement when MRI scans checked their tumors after treatment. For those with less aggressive tumors, survival after PRDR treatment lasted up to 22 months. This method suits large brain tumors and can lead to reasonable survival times. PRDR radiotherapy is effective with manageable side effects, making it a promising option for treating recurrent brain cancers. ^{1 2 4 5 6}

Who Is on the Research Team?

Robert Press, M.D.

Principal Investigator

Miami Cancer Institute at Baptist Health, Inc.

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My brain tumor is growing or has come back.

I can do most of my daily activities by myself.

Prospective participants who have not passed an interval of at least 6 months may still be eligible if they meet one or more of the following criteria:

Exclusion Criteria

My cancer is present in multiple locations.

I have undergone radiotherapy at least twice.

My cancer has spread to the lining of my brain and spinal cord.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive proton pulsed reduced dose rate (PRDR) radiotherapy to assess its effects on recurrent high-grade glioma

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of progression-free survival and adverse events

2 years

What Are the Treatments Tested in This Trial?

Interventions

• PRDR

Trial Overview 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.

How Is the Trial Designed?

Group I: PRDR Radiotherapy Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Baptist Health South Florida

Lead Sponsor

Trials

54

Recruited

8,100+

Ion Beam Applications SA

Collaborator

Trials

1

Recruited

30+

Ion Beam Applications

Industry Sponsor

Published Research Related to This Trial

In a study of 75 patients with low rectal cancers who underwent preoperative radiotherapy (PRT), the most common adverse events were leukocytopenia (12%) and diarrhea (24%), primarily classified as mild to moderate (grade 1-2).

Interestingly, patients who experienced these adverse events had a significantly better 5-year relapse-free survival rate (94% for those with leukocytopenia or diarrhea vs. 49% for those without), suggesting that these side effects may indicate a more favorable prognosis and should not deter the use of PRT in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prognostic significance of adverse events associated with preoperative radiotherapy for rectal cancer. Ishihara, S., Watanabe, T., Akahane, T., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9221236/

Pulsed-Reduced Dose Rate (PRDR) Radiotherapy for ... At a median follow-up of 8.7 months, the median PFS and OS were 5.7 months (95%CI: 2.1–15.4 months) and 6.7 months (95%CI: 3.2–14.2 months), ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11154132/

Pulsed reduced-dose rate re-irradiation for patients with ... Overall response rate based on post-PRDR MRI was 36%. In patients who maintained grade 2 histology at recurrence, overall survival from PRDR was 22.0 months ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1879850017301091

Intensity modulated radiation therapy with pulsed reduced ... IMRT PRDR reirradiation is a feasible and appropriate treatment strategy for large volume recurrent CNS tumors, resulting in reasonable survival.

4. advancesradonc.org advancesradonc.org/article/S2452-1094(20)30170-6/pdf

Outcomes From Whole-Brain Reirradiation Using Pulsed ... Here, we report our experience using whole-brain pulsed reduced dose rate radiation therapy (PRDR), a method that delivers radiation at a slower rate of 0.067 ...

5. cco.amegroups.org cco.amegroups.org/article/view/139535/html

Pulsed reduced dose rate radiotherapy: a narrative review - Atak It is particularly effective for CNS tumors with manageable toxicity and shows potential in recurrent breast, head and neck, and gastrointestinal cancers.

6. academic.oup.com academic.oup.com/noa/article/6/1/vdae073/7668086

Pulsed reduced-dose rate re-irradiation for patients with ... Pulsed reduced-dose rate (PRDR) re-irradiation is safe and generally well tolerated. Prognosticators: KPS, 1p19q codeletion, grade change, and ...