Evaluation of the irinotecan/bevacizumab combination used as neoadjuvant and adjuvant therapy to concurrent temozolomide chemoradiotherapy for unresectable glioblastomas. Randomized phase II trial comparing irinotecan to concurrent and adjuvant temozolomide chemoradiotherapy - GBM-ANOCEF 2008-01

PRIMARY OUTCOME: Main Objective: Increase in 6-month Progression-Free Survival (PFS) from 50% to 66% (increase in median PFS from 6 to 10 months). Primary endpoint(s): 6-month Progression-Free Survival (PFS) assessed according to Macdonald criteria. Secondary Objective: - Evaluate Overall Survival; - Evaluate Response Rate after the neoadjuvant phase; - Evaluate Response Rate over the entire treatment period; - Evaluate Quality of Life (Karnofky index, neurological status, QLC-C30 scale and specific QLQ-BN20 module for brain tumors); - Evaluate Tolerability (NCI-CTCAE scale, version 3); - Additional translational studies: * biological factors predictive of response to bevacizumab; * analysis of response to neoadjuvant treatment by new imaging techniques; MRI; INCLUSION CRITERIA: - informed consent form signed by the patient - age over 18 years and under 70 years - WHO grade IV malignant gliomas (glioblastomas, GBM), histologically confirmed by stereotactic or surgical biopsy - patients belonging to prognostic class RPA V (appendix 10.7) - GBM only supratentorial - gliomas judged unresectable in multidisciplinary consultation meeting. - Time ≥ 14 days after stereotactic biopsy - Normal hematopoietic function: neutrophils > 1500/mm3, platelets > 100,000/mm3 - Normal renal function: creatinine < 1.2 ULN (upper limit of normal); proteinuria < 1 g/L - Normal liver function: prothrombin time > 70%; AST/ALT < 2.5 ULN; bilirubin < 1.5 ULN - Good general condition (Karnofsky Performance Status > 50) - Estimated survival probability of at least 3 months. Are the trial subjects under 18? No. Number