Actively Recruiting
Protective VEGF Inhibition for Isotoxic Dose Escalation in Glioblastoma
Led by University Hospital Tuebingen · Updated on 2026-01-09
146
Participants Needed
1
Research Sites
221 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Protective VEGF Inhibition for Isotoxic Dose Escalation in Glioblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with IDH wild-type, MGMT unmethylated glioblastoma
- Age between 18 and 70 years, any ethnicity, smokers or non-smokers
- Performance status ECOG 0 to 2
- Neutrophil count greater than 1500/µl
- Platelet count greater than 100,000/µl
- Hemoglobin level greater than 8 g/dl
- Serum creatinine less than 1.5 times the upper limit of normal
- Bilirubin, AST or ALT less than 2.5 times the upper limit of normal unless due to anticonvulsants
- Alkaline phosphatase less than 2.5 times the upper limit of normal
- Adequate contraception
- Urine dipstick proteinuria less than 2+ or urine protein to creatinine ratio less than or equal to 1 if proteinuria is 2+ or higher
You will not qualify if you...
- Evidence of significant bleeding on postoperative brain MRI, except minor or resolving hemorrhagic changes
- Use of any drug that may interfere with bevacizumab at the time of study inclusion
- Immunocompromised status, including known HIV infection
- Known allergy or intolerance to bevacizumab or excipients
- Any serious medical illness or lab finding making participation unsafe
- Inability to undergo MRI
- Prior bevacizumab treatment for any indication
- Significant heart disease such as congestive heart failure (NYHA Class II-IV), unstable angina, or recent heart attack within 6 months
- Poorly controlled high blood pressure or history of hypertensive crisis
- Recent cerebrovascular events like stroke or transient ischemic attack within 6 months
- Significant vascular diseases such as aortic aneurysm or recent peripheral arterial thrombosis within 6 months
- History of repeated blood clots in the past 2 years
- Bleeding disorders without therapeutic anticoagulation
- Daily aspirin use over 325 mg or clopidogrel over 75 mg
- History of brain abscess within 6 months
- History of abdominal or tracheo-esophageal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months
- Recent significant coughing up of blood within 1 month
- Serious non-healing wounds, ulcers, or bone fractures
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Department of Radiation Oncology
Tübingen, Germany, 72076
Actively Recruiting
Research Team
B
Barbara Gehler, Dr. med.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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