Phase III Study Comparing 2 Brain Conformational Radiotherapy in Combination With Chemotherapy in… (NCT01507506) | Clinical Trial Compass
TerminatedPhase 3
Phase III Study Comparing 2 Brain Conformational Radiotherapy in Combination With Chemotherapy in the Treatment of Glioblastoma
France180 participantsStarted 2011-03-15
Plain-language summary
This is a multi-institutional phase III clinical study of interventional type. The trial will include 220 patients with confirmed unifocal glioblastoma over a period of 3 years + 3 years of follow up.
Patients with unifocal glioblastoma (diagnosis confirmed by histology on tumoral biopsy or surgical specimen) and who meet all eligibility criteria will be randomized in one chemoradiotherapy arm :
* Conventional arm: 3-dimensional conformational radiotherapy + Temozolomide
* Experimental arm : simultaneous-integrated boost with intensity-modulated radiotherapy guided by magnetic resonance spectroscopic imaging + Temozolomide The patient monitoring will be regular and standardized. The main objective of this study is to improve overall survival of patients treated in experimental group (with simultaneous integrated boost).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients must have unifocal glioblastoma (grade IV astrocytoma, WHO classification). The GBM can be:
✓. In all cases, the diagnosis must be confirmed by a pathologist. In patients for whom surgery is not possible, the diagnosis is confirmed by a biopsy of tumor tissue.
✓. Methylation status of MGMT gene promoter is known
✓. Patients who have undergone resection should have received an MRI or a scan after surgery in order to visualize residual tumor. If not, the operative report must be available.
✓. Surgery or biopsy must have occurred 45 days before the start of radiotherapy.
✓. WHO ≤ 2
✓. Age ≥ 18 years
✓. Signed Consent collected before any specific procedure in the study
Exclusion criteria
✕. Signs of hemorrhage on pre-radiotherapy MRI preventing a good spectrometric analysis
What they're measuring
1
Overall survival defined as the time from randomization to the date of death or date of last follow-up news (censured data)