Newly Diagnosed Glioblastoma in Patients =70 Years Clinical Trial
Official title:
Effect of Timing of Tumor-Treating Fields Plus Short-Course Radiation in Elderly Patients With Glioblastoma
The purpose of the study is to assess timing of TTFields use as well as safety, feasibility and preliminary efficacy of treatment with TTFields in elderly patients with newly diagnosed GBM simultaneous to RT/ CRT. The primary aim of the trial is to establish a safely conducted therapy rate higher than 0.8 in the treatment arm.
Despite the immense effort made over the years with different treatment modalities, the survival of patients with newly diagnosed GBM is still very poor; no treatment is curative; and the quality of life of patients with this tumor is compromised significantly, not only by their disease but also by side effects of these rigorous treatment plans. Especially in elderly patients, a treatment modality is needed that will improve the results of current standard treatments without further impairing the quality of life of these patients for their limited life span. The objective is to test the feasibility and timing of treatment with the TTFields device in elderly patients with newly diagnosed GBM simultaneous or subsequent to RT/ CRT. The primary rationale to conduct this study is to improve treatment in the segment of high-grade brain tumors with the highest medical need. All procedures regarding TTFields are representing routine clinical care within the approved use of the medical product in Germany; the present trial aims to investigate the optimal timing of TTFields use in elderly GBM patients. ;