Effect of Timing of Tumor-Treating Fields Plus Short-Course Radiation (GERAS)

Juergen Debus

Status: Withdrawn

Conditions: Newly Diagnosed Glioblastoma in Patients ≥70 Years

Treatments: Device: TTFields

Study type: Interventional

Funder types: Other

Identifiers

NCT04218019

GERAS

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed, newly diagnosed glioblastoma (astrocytoma WHO grade IV)
• Indication for hypofractionated radiotherapy or hypofractionated chemo-radiotherapy with temozolomide
• Open biopsy or resection
• Craniotomy or intracranial biopsy site must be adequately healed
• Informed consent
• Age: >65 years
• KPS ≥50%
• Ability of subject to understand character and individual consequences of the clinical trial
• Written informed consent of participation

Exclusion criteria

• Concurrent participation in another competing interventional clinical trial studying a drug or treatment regimen.
• Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol requirements and/or follow-up procedures; those conditions should be discussed with the patient before trial entry
• Prior RT of the brain
• Patients who have not yet recovered from acute high-grade toxicities of prior therapies
• MRI or TTFields contraindication (e.g. cardiac pacemaker, implanted defibrillator, certain cardiac valve replacements, certain metal implants, patients with severe skull defects such as a missing bone flap, programmable shunts)
• Known hypersensitivity to conductive hydrogels
• Pregnant and lactating women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Early Tumor Treating Fields (TTFields, Optune®) treatment

Experimental group

Description:

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.

Treatment:

Device: TTFields

Late TTF treatment

Active Comparator group

Description:

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.

Treatment:

Device: TTFields