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The investigators propose to conduct a multicenter, open-label, randomized, phase II study in patients with newly diagnosed glioblastoma (CeCil). Patients should meet all eligibility criteria for the CENTRIC phase III trial at the exception that no MGMT-promoter methylation could be demonstrated. The treatment backbone in both study arms will consist of postoperative radiation therapy with concomitant daily temozolomide, followed by 6 cycles of temozolomide according to a 21 out of 28 days regimen (as in the experimental arm of the RTOG 0525 / EORTC 26052-22053 phase III study). In study arm (A) Cilengitide (at a dose of 2000 mg by iv administration, 2x/week) will be added to this backbone while in the second study arm (B), Cetuximab will be added (at an initial dose of 400 mg/m² administered by intravenous infusion over 2 hours and followed by a weekly dose of 250 mg/m² iv over 1 hours). In both study arms, treatment will be administered for 52 consecutive treatment weeks. The 1-year overall survival (1y-OS) following randomization will serve as the primary endpoint in both study arms.
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Newly diagnosed histologically proven supratentorial glioblastoma (World Health Organization [WHO] Grade IV, including glioblastoma subtypes, e.g. gliosarcoma).
Tumor tissue specimens from the glioblastoma surgery or open biopsy (FFPE block) must be available for MGMT gene promoter status analysis and central pathology review and must have been submitted as part of the screen procedure for the CENTRIC phase III study
MGMT gene promoter status determined as NOT methylated during the screen procedure for the CENTRIC phase III study
Males or females ≥18 years of age.
Interval of ≥2 weeks but ≤7 weeks after surgery or biopsy before first administration of study treatment.
Available post-operative Gd-MRI performed within 48 hours after surgery
Stable or decreasing dose of steroids for 5 days prior to randomization.
Eastern Cooperative Oncology Group performance score (ECOG PS) of 0-1.
Meets one of the following recursive partitioning analysis (RPA) classifications:
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12 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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