To evaluate the efficacy and safety of Optune® administered concurrently with radiotherapy (RT) and temozolomide (TMZ) in newly diagnosed GBM patients compared to radiotherapy and temozolomide alone.
Aim of the study
The study will investigate the treatment of a newly diagnosed glioblastoma multiforme (brain tumor) with the Optune® device. We are conducting this study to evaluate whether earlier concomitant therapy with Optune® already at the time of radiotherapy (administered together with temozolomide) improves clinical outcome compared to standard treatment of glioblastoma multiforme (GBM).
Who can take part?
Patients with newly diagnosed GBM
Procedure
Patients are randomly assigned to one of two groups. In both groups, the standard treatment of a GMB is applied (surgical resection as far as safely possible, followed by RT as adjuvant treatment to TMZ, followed by adjuvant TMZ chemotherapy as adjuvant treatment to TTField). In group A, the Optune® device is integrated into the treatment at an earlier stage in addition to the standard treatment of GBM and is used together with radiotherapy.
Compensation
None
Original study name
Randomized, open-label pivotal study of Optune® (tumor treatment fields, 200kHz) in combination with radiotherapy and temozolomide for the treatment of newly diagnosed glioblastoma
BASEC number
2020-02548
Financial support from
NovoCure Ltd