An interventional study of TTFields in Newly Diagnosed Glioblastoma in Patients ≥70 Years, sponsored by Juergen Debus. Withdrawn at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-05.
Sponsored by Juergen Debus · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
TTF will be started together with hypofractionated radiotherapy (+/- 5 days) with or without Temozolomide (according to the standard and local physician's decision). Chemoradiotherapy with temozolomide and hypofractionated radiotherapy is regarded as standard therapy and not part of the intervention. In case of chemoradiotherapy temozolomide will be applied according to the standard of the participating trial center. Use of antiemetic and infection prophylaxis will be at the discretion of the investigator.
Device: TTFields
Patients will be treated with hypofractionated radiotherapy with or without temozolomide (according to the local standard and physician's decision). Radiotherapy and treatment with temozolomide is regarded as standard therapy and not part of the intervention. In case of chemoradiotherapy temozolomide will be applied according to the standard of the participating trial center. Use of antiemetic and infection prophylaxis will be at the discretion of the investigator. Late TTFields treatment will start 4 weeks after the end of radiotherapy.
Device: TTFields
The NovoTTF-200 A device used in this trial delivers very low intensity, alternating electric fields to the tumor site through the scalp. These fields are known as Tumor Treating Fields or TTFields.
Safely conducted therapy rate (SCTR)
The proportion of patients fulfilling the inclusion/exclusion criteria who were treated for at least one week according to protocol and neither experienced neither NCI-CTC-AEs of Grade 3 nor 4
Time frame: at least one week of treatment
Number of participants with treatment related adverse events as assessed by CTCAE V 5.0.
Safety and tolerability of TTFields Treatment combined with radiotherapy/chemo-radiotherapy
Time frame: within 31 weeks after treatment
Progression-free survival
according to RANO criteria
Time frame: within 6 month after treatment
The correlation between the Optune device usage and the health-related quality of life of elderly patients and families undergoing this therapy in combination with radiotherapy/chemo-radiotherapy.
Score on the EORTC QoL C15-Pal
Time frame: within 31 weeks after treatment
The correlation between the Optune device usage and the health-related quality of life of elderly patients and families undergoing this therapy in combination with radiotherapy/chemo-radiotherapy.
Score on the EORTC QoL BN20
Time frame: within 31 weeks after treatment
Plan to share: No
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This study is withdrawn, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Juergen Debus