Glioblastoma (GBM) is the most aggressive and most frequent brain tumour. Approximately four people per 100,000 inhabitants are diagnosed with this disease every year. The standard treatment comprises surgical resection (whenever possible), normofractionated radiotherapy at a dose of 60Gray (Gy) and temozolomide (TMZ). Median overall survival in these patients is 14.6 months \[13.2-16.8\]. In a previous phase I clinical trial, dose escalation tolerance using simultaneous-integrated boost intensity-modulated radiation therapy (SIB-IMRT) technic has been evaluated. The investigator demonstrated that SIB-IMRT until a dose of 80Gy in 32 daily fractions, associated with TMZ is feasible and well tolerated by patients with glioblastoma. The aim of this present phase II clinical trial is to evaluate the overall survival at 18 months for patients with glioblastoma receiving TMZ, according to standard protocol, associated to radiotherapy delivered at 80Gy using SIB-IMRT technic. The first planning target volume (PTV), including oedema and tumour highlighted on T2 flair magnetic resonance imaging (MRI) sequences, will receive 60.8Gy in 32 daily fractions. The second PTV, including tumour highlighted on T1 MRI sequences, will receive 80.0Gy in 32 daily fractions. Secondary objectives are tolerance, survival free progression and quality of live evaluations. Sixty seven patients will be enrolled in this present trial.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
67
Radiotherapy of 80 GY + Chemotherapy (Temozolomide)
CHU Amiens Picardie
Amiens, France
CHU Besançon
Besançon, France
Centre Georges François Leclerc
Dijon, France
Centre d'oncologie et de radiothérapie
Mâcon, France
Institut de cancérologie de Lorraine
Nancy, France
Paul Strauss
Strasbourg, France
Centre de cancérologie des dentellières
Valenciennes, France
Overall survival
Time frame: 18 months
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