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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
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.
Lynn Cancer Institute at Baptist Health, Inc.
Boca Raton, Florida, United States
NOT_YET_RECRUITINGMiami Cancer Institute at Baptist Health, Inc.
Miami, Florida, United States
RECRUITINGProgression-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).
Time frame: 3 months
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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.