- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04218019
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
Intervention / Treatment
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
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Heidelberg, Germany, 69120
- University Hospital of Heidelberg, Radiation Oncology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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)
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.
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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.
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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.
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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)
Time Frame: at least one week of treatment
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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
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at least one week of treatment
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Number of participants with treatment related adverse events as assessed by CTCAE V 5.0.
Time Frame: within 31 weeks after treatment
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Safety and tolerability of TTFields Treatment combined with radiotherapy/chemo-radiotherapy
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within 31 weeks after treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival
Time Frame: within 6 month after treatment
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according to RANO criteria
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within 6 month after treatment
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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.
Time Frame: within 31 weeks after treatment
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Score on the EORTC QoL C15-Pal
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within 31 weeks after treatment
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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.
Time Frame: within 31 weeks after treatment
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Score on the EORTC QoL BN20
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within 31 weeks after treatment
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jürgen Debus, Prof., head of department
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GERAS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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