Concomitant Association of Ultrafractionated Brain Irradiation - Temozolomide in Inoperable Primary Glioblastoma Multiforme

Phase II Clinical Trial of Concomitant Association of Ultrafractionated Brain Irradiation - Temozolomide in Inoperable Primary Glioblastoma Multiforme

The main purpose of this study is the evaluation of concomitant association of ultrafractionated irradiation and Temodal® in patients with inoperable primary glioblastoma multiforme; study of tolerance and objective response rate.

The secondary purposes of this study are the evaluation of progression free survival, global survival and tolerance through toxicity study. The therapeutic response according to methylation or not of MGMT is also evaluated.

Inclusion Criteria:

• giving their informed consent
• having a supratentorial malignant glioma, either grade 4 of St. Anne/Mayo grading, or glioblastoma multiforme according to WHO classification
• having an inoperable brain tumor (diagnosed by stereotactic biopsy)
• having a general status, evaluated by Karnofsky scale, >60
• having a life expectancy >3 months
• not having previously had a brain irradiation and/or adjuvant or neo-adjuvant chemotherapy
• potentially having another cancer, if histology and clinical history are available for comparison
• being able to take oral tablets
• no HIV disease
• satisfactory hematology, hepatic and renal functions: polymorphonuclear neutrophils >1500/mm3, platelets >100000/mm3, Hb >8g/dl, creatinemia ≤1.5 times upper normal value, total bilirubin <1.5 times upper normal value, ASAT and ALAT <3 times upper normal value
• for women of childbearing potential, a contraception is given

Exclusion Criteria:

• having an under tentorial malignant glioma (brain stem and/or cerebellum), grade 4 of St. Anne/Mayo grading
• having a Karnofsky score <60
• having a life expectancy <3 months
• having had a brain irradiation or an adjuvant or neoadjuvant chemotherapy
• refusing any additional therapy
• having a non-malignant but serious systemic disease or uncontrolled active infection
• having a severe psychiatric disorder
• not having signed the informed consent
• pregnant or breastfeeding woman