NOA-09 / CeTeG-Studie

Randomized phase III trial of combined CCNU/temozolomide (TMZ) therapy vs. standard temozolomide therapy in the primary treatment of patients with newly diagnosed MGMT-methylated glioblastoma

The BMBF-funded CeTeG study investigates whether combined CCNU/TMZ therapy in addition to standard radiotherapy is superior to standard TMZ therapy (Stupp regimen) in terms of overall survival. Only patients in whom a methylated MGMT promoter could be detected were included. This is based on the fact that in a single-arm preliminary study (UKT-03, Glas et al., J Clin Oncol 27:1257-1261, 2009) evidence for efficacy of combination therapy was found only in this subgroup. From 06/2011 to 08/2014, 141 patients were included in 17 German centers (1:1 randomization). According to protocol, an evaluation of the primary endpoint overall survival will be performed at earliest 04/2017 (2 years after recruitment end).