PrOton Pulsed reduCed dOse Rate Radiotherapy for Recurrent CNS maligNancies Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBaptist Health South Florida
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Karnofsky performance status ≥ 50
Histologically-confirmed or radiographic evidence of recurrent / progressive glioma
Prior treatment with radiotherapy to a minimum dose of 45 Gy
New areas of tumor outside the original radiotherapy fields as determined by the investigator.
Disqualifiers
Two or more courses of prior radiotherapy
Inability to undergo an MRI with contrast
Leptomeningeal evidence of recurrent disease
Multi-focal disease
Trial design
Design model
Single group
Treatments tested in this trial
PRDR
RadiationProton 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.
Treatment groups
28 Participants
are divided into 1 treatment groupGroup A: PRDR RadiotherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
3 monthsSecondary outcomes
1
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 years2
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 years3
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 years4
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 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Baptist Health South Florida
Lead sponsor
Ion Beam Applications
Collaborator
Source ClinicalTrials.gov