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

Trial Summary

What is the purpose of this 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.

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 data supports the effectiveness of the treatment PRDR for recurrent brain cancer?

Research shows that PRDR, a method of delivering radiation at a slower rate, can help repair damage and reduce side effects. It has been used successfully in treating recurrent head and neck cancer and high-grade glioma, suggesting it may be effective for recurrent brain cancer as well. ^{1 2 3 4 5}

Is PRDR radiotherapy generally safe for humans?

PRDR radiotherapy has been used as a reirradiation technique for various brain tumors, including recurrent central nervous system tumors and meningiomas. Studies suggest that it is generally well tolerated, with the slower delivery rate potentially reducing side effects by allowing the body to repair some damage during treatment. ^{1 2 5 6 7}

How is PRDR treatment different for recurrent brain cancer?

PRDR (Pulsed Reduced Dose Rate) radiotherapy is unique because it delivers radiation at a slower rate, allowing for better repair of sublethal damage and reducing toxicity compared to conventional reirradiation methods. This approach is particularly beneficial for patients with recurrent brain cancer who have already undergone radiation therapy, as it helps manage the risk of further damage to healthy brain tissue. ^{1 2 3 5 8}

Research Team

Robert Press, M.D.

Principal Investigator

Miami Cancer Institute at Baptist Health, Inc.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Reirradiation of large-volume recurrent glioma with pulsed reduced-dose-rate radiotherapy. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Outcomes From Whole-Brain Reirradiation Using Pulsed Reduced Dose Rate Radiation Therapy. [2022]

3. Greece pubmed.ncbi.nlm.nih.gov

Use of cetuximab in combination with pulsed reduced dose-rate radiotherapy in a patient with recurrence of nasopharyngeal carcinoma in the neck. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Pulsed Reduced Dose Rate Radiotherapy in Conjunction With Bevacizumab or Bevacizumab Alone in Recurrent High-grade Glioma: Survival Outcomes. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Intensity modulated radiation therapy with pulsed reduced dose rate as a reirradiation strategy for recurrent central nervous system tumors: An institutional series and literature review. [2018]

6. Germany pubmed.ncbi.nlm.nih.gov

Prognostic significance of adverse events associated with preoperative radiotherapy for rectal cancer. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Large volume re-irradiation for recurrent meningioma with pulsed reduced dose rate radiotherapy. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Pulsed reduced dose-rate radiotherapy for previously irradiated tumors in the brain and spine. [2022]