Protective VEGF Inhibition for Isotoxic Dose Escalation in Glioblastoma
ConditionGlioblastoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity Hospital Tuebingen
About this trial
Glioblastoma is the most aggressive brain tumor and often recurs locally despite intensive treatment. Standard chemoradiotherapy with 60 Gy may not be sufficient to control the tumor, and dose escalation seems to be warranted, but causes more toxicity. To address this, the multicentric PRIDE trial employs two cycles of bevacizumab to achieve dose escalation isotoxically. The goal is improved survival without significantly increasing side effects. The study uses a simultaneous integrated boost with a total dose of 75 Gy in 2.5 Gy per fraction.
Eligibility criteria
Qualifiers
IDH wild-type, MGMT unmethylated glioblastoma patients
Informed consent
Age ≥18 and ≤70 years, smoking or non-smoking, of any ethnic origin
ECOG 0-2
Disqualifiers
Evidence of significant hemorrhage on postoperative MRI of the brain. Patients with asymptomatic, minor hemosiderin deposition, resolving postsurgical hemorrhagic changes, or punctate intratumoral hemorrhage (e.g., related to biopsy or surgery) are not excluded
Subjects on any drug suspected to interfere with bevacizumab at the time of study inclusion
Immuno-compromised patients, including known seropositivity for human immunodeficiency virus (HIV)
Known hypersensitivity to any component of the investigational drugs or excipients (allergy to or other intolerability of bevacizumab or excipients)
Trial design
Treatments tested in this trial
- Dose escalation of radiation dose beyond the therapeutic standard
Treatment groups
146 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov