Protective VEGF Inhibition for Isotoxic Dose Escalation in Glioblastoma
Trial Parameters
Brief Summary
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
Inclusion Criteria: * 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 Exclusion Criteria: * 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 bevacizum