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METHODS: We conducted an international, multicenter, prospective, randomized phase III trial in newly diagnosed GBM patients. After completion of radiotherapy (RT) with concomitant temozolomide (TMZ), patients were randomized (2:1) to adjuvant TMZ with NovoTTF or adjuvant TMZ alone. The primary endpoint was progression-free survival (PFS), with overall survival (OS) an important secondary endpoint. Here we report on a pre-specified interim analysis of the first 315 patients randomized, after a minimum follow-up of 18 months (range 18-60 months).

neuro-oncology

NT-40 * Interim Analysis of the EF-14 Trial: A Prospective, Multi-center Trial of NovoTTF-100A Together With Temozolomide Compared to Temozolomide Alone in Patients with Newly Diagnosed GBM