Newly Diagnosed Glioblastoma in Patients ≥70 YearsGERASNCT04218019
Effect of Timing of Tumor-Treating Fields Plus Short-Course Radiation
A study testing TTFields in people with Newly Diagnosed Glioblastoma in Patients ≥70 Years, run by Juergen Debus at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Newly Diagnosed Glioblastoma in Patients ≥70 Years
- What is being tested?
- TTFields
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2023to 1 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- KPS ≥50%
- Ability of subject to understand character and individual consequences of the clinical trial
- Written informed consent of participation
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Germany1 site
University Hospital of Heidelberg, Radiation Oncology
Heidelberg, 69120
About this study
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.
Read the 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.
- Being tested
- TTFields
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TTFieldsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Early Tumor Treating Fields (TTFields, Optune®) treatment | Experimental | 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. Receives: Device: TTFields |
| Late TTF treatment | Active comparator | 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. Receives: Device: TTFields |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: within 31 weeks after treatment
Secondary outcomes (3)
Progression-free survival
according to RANO criteria
Measured: 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
Measured: 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
Measured: within 31 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start1 Aug 2023
- Primary completion1 Aug 2023
- Study completion1 Aug 2023
Why it stopped: Organizational reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newly Diagnosed Glioblastoma in Patients ≥70 YearsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Juergen Debus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Juergen Debus, University Hospital Heidelberg
- Investigators
- Jürgen Debus, Prof., Principal investigator, Head of Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04218019
- Sponsor's protocol ID
- GERAS
- Acronym
- GERAS
- Status last verified
- Jan 2024
- First submitted
- 2 Jan 2020
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Timing of Tumor-Treating Fields Plus Short-Course Radiation in Elderly Patients With Glioblastoma
- ClinicalTrials.gov ID
- NCT04218019
- Acronym / sponsor ID
- GERAS / GERAS
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Organizational reasons
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Juergen DebusUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 6 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Tumor Treating Fields (TTFields, Optune®) treatment | Experimental | Device: TTFieldsTTF 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. |
| Late TTF treatment | Active comparator | Device: TTFieldsPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TTFieldsThe 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. | Device | Early Tumor Treating Fields (TTFields, Optune®) treatment, Late TTF treatment |
Primary outcome
Safely conducted therapy rate (SCTR)
Time frame: at least one week of treatment
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
Number of participants with treatment related adverse events as assessed by CTCAE V 5.0.
Time frame: within 31 weeks after treatment
Safety and tolerability of TTFields Treatment combined with radiotherapy/chemo-radiotherapy
3 secondary outcomes
Progression-free survival
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.
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.
Time frame: within 31 weeks after treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jürgen Debus, Prof. principal investigator
Head of Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TTFields in people with Newly Diagnosed Glioblastoma in Patients ≥70 Years, run by Juergen Debus at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safely conducted therapy rate (SCTR) (time frame: at least one week of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024; AzTrials last refreshed its copy on 7 Nov 2026.