Clinical Trial Finder

Inclusion Criteria:

All the eligibility criteria must be met before registration :

• - delay upper or equal to 14 days from stereotaxic biopsy and 28 days from surgical biopsy.

• - Histopathologically proven diagnosis of glioblastoma (WHO grade IV astrocytoma) - Patient belonging to the RPA V class or associated.

• - only supratentorial glioblastoma.

• - Diagnosis must be obtained by a stereotactic or surgical biopsy.

• - Age between 18 and 70.

• - A contrast-enhanced MRI must be performed within 28 days prior to study registration.

• - Total or partial surgical resection deemed as not possible by a neurosurgeon.

• - Karnofsky Index (KI) performance status over 50.

• - Life expectancy of at least 3 months.

• - A stable dose of corticosteroid for at least 7 days to control intracranial pressure and neurological symptoms.

• - Adequate blood function : absolute neutrophil count > 1.5 x 109/L, platelets count > 100 x 109/L platelets; hemoglobin > 10 g/dl after blood transfusion if required.

• - Adequate liver function: bilirubin < 1.5 ULN (upper limit of normal), ALT and AST < 2.5 ULN, Prothrombin rate > 75 % - Adequate renal function: creatinine < 1.2 ULN; proteinuria test 0 or trace (or urine protein concentration < 1g/24h if proteinuria test is + or ++).

• - Negative pregnancy test for women of childbearing potential and adequate contraception for men and women.

• - systolic arterial blood pressure at rest ≤ 170 mmHg.

• - Patient must have been informed and must have signed the specific informed consent form.

• - holder of a coverage by the health insurance.

Exclusion Criteria:

• - patient belonging to the RPA III or IV.

• - prior malignant tumor in the recent 5 years or concomitant malignancy.

• - prior anti-tumoral chemotherapy or radiotherapy.

• - prior gross resection of the brain tumor.

• - patient receiving gliadel.

• - cardiovascular contra-indications to bevacizumab : prior angina pectoris, prior myocardial infarction, prior brain stroke, even transient, distal severe arteriopathy, uncontrolled high blood pressure.

• - anticomitial drug p450 cytochrome inductors.

• - other substances inducing p450 cytochrome.

• - proteinuria ≥ 1g/L.

• - concurrent anticoagulant or platelet anti-aggregant treatment.

• - congenital haemorrhagic pathology (haemophilia, Willebrandt) - sign of brain haemorrhage on the RMI initial exam.

• - non resolved infectious disease.

• - non controlled arterial hypertension (≥170 mmHg) - intracranial high pressure not controlled by a stable dose of steroids for at least 7 days.

• - pregnancy or refusal of the contraception for women and men.

• - psychiatric, behavioural disorders or geographical situation precluding the administration or follow-up of the protocol (including claustrophobia) - digestive haemorrhage and / or gastro-duodenal ulcer occurring in the last 3 months.

• - pregnant, nursing woman, or without contraception.

- private individuals of freedom or under tutelage (including legal guardianship)

Arms

Experimental: Bevacizumab/Irinoecan

Neoadjuvant Treatment Patient will receive bevacizumab 10mg/kg plus irinotecan 125mg/m² 4 times every two weeks. Radiochemotherapy Then they will receive conformational radiotherapy for 6 weeks (30 Gy, 2Gy/fractions) associated with Temodal ( 75mg/m²/day) from first day up to the end of radiotherapy and 4 injections of Avastin (15mg/kg Day 1, day 15, day 29 and day 43). Adjuvant treatment: Patients will receive bevacizumab 15mg/kg plus irinotecan 125mg/m² 12 times every two weeks.

Active Comparator: Stupp

patient will receive 6 weeks chemotherapy treatment associating conformational 30 Gy (2Gy/ fraction)and Temodal(75mg/m²/day, followed by 6 months adjuvant therapy consisting in 5 days every 28 days of Temodal (150-200mg/m².

Interventions

Drug: - Avastin + Campto / radiotherapy + Temodal + Avastin (4 cures)

Drug: - Temodal/radiotherapy