Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2025-12-25 @ 4:49 AM
NCT ID:
NCT01022918
Eligibility Criteria:
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01022918
Study Brief:
Protocol Section:
NCT01022918