A Phase IIa, Open-label, Multicenter Study of Radiochemotherapy With Isotoxic Dose Escalation and Protective VEGF Inhibition Using Bevacizumab in the Treatment of Patients With First Diagnosis of IDH Wild-type, MGMT Unmethylated Glioblastoma
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.
• 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
• Neutrophil counts \> 1500/μl; Platelet counts \> 100.000/μl; Hemoglobin \> 8 g/dl; Serum creatinine \< 1.5-fold upper limit of normal (ULN); Bilirubin, AST or ALT \< 2.5-fold ULN unless attributed to anticonvulsants; Alkaline phosphatase \< 2.5-fold ULN
• Adequate contraception
• Serum creatinine ≤ 1.5 x ULN AND patients with urine dipstick for proteinuria \< 2+. Patients with ≥ 2+ proteinuria on dipstick urinalysis at baseline should show urine protein to creatinine ratio ≤ 1