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

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.

Study Overview

• Status: Withdrawn
• Conditions: Newly Diagnosed Glioblastoma in Patients ≥70 Years
• Intervention / Treatment: Device: TTFields

Detailed 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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Heidelberg, Germany, 69120
    • University Hospital of Heidelberg, Radiation Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early Tumor Treating Fields (TTFields, Optune®) treatment; 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; 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.
Active Comparator: Late TTF treatment; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	within 31 weeks after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival	according to RANO criteria	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	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	within 31 weeks after treatment

Collaborators and Investigators

• Sponsor: Juergen Debus
• Investigators: Principal Investigator: Jürgen Debus, Prof., head of department

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Actual): August 1, 2023
• Study Completion (Actual): August 1, 2023

Study Registration Dates

• First Submitted: January 2, 2020
• First Submitted That Met QC Criteria: January 3, 2020
• First Posted (Actual): January 6, 2020

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 4, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma
• Other Study ID Numbers: GERAS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No