PrOton Pulsed reduCed dOse Rate Radiotherapy for Recurrent CNS maligNancies (POPCORN) Trial

Baptist Health South Florida2 sites in 1 country28 target enrollmentApril 30, 2025

ConditionsGlioma Glioma, Malignant Recurrent Glioma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Glioma
Sponsor: Baptist Health South Florida
Enrollment: 28
Locations: 2
Primary Endpoint: Progression-free survival (PFS)
Status: Recruiting
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 30, 2025

End Date

June 1, 2029

Last Updated

10 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Baptist Health South Florida

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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:

Exclusion Criteria

•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.

Outcomes

Primary Outcomes

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).

Secondary Outcomes

Quality of life (QOL) assessed by the EuroQOL 5-dimension, 5-level (EQ-5D-5L)(1 year)
Overall survival (OS)(2 years)
Treatment-related adverse events (AEs) assessed by Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0)(2 years)
Assessment of symptoms using the MD Anderson Symptom Inventory for Brain Tumors (MDASI-BT)(1 year)
Grade 3 central nervous system (CNS) toxicities assessed by CTCAE v5.0(2 years)