Plain English Summary
Background and study aims
Glioblastoma (GBM) is the most common malignant primary tumor (cancer) of the brain. The current standard of care for patients with newly diagnosed GBM consists of maximal surgical resection (surgically removing the cancer), radiotherapy together with chemotherapy using temozolomide (TMZ), followed by maintenance TMZ for six months. This treatment scheme was shown to extend median survival from 12.1 to 14.6 months compared to surgery and radiotherapy alone. This survival was essentially unchanged since 2005 despite numerous other studies. Although immense efforts have been made over the years with different treatment strategies, the survival of patients with newly diagnosed GBM remained very poor until recently. Tumor-treating fields (TTFields) are low-intensity, intermediate frequency, alternating electric fields delivered continuously through adhesive patches, called transducer arrays, to the area of the brain where the GBM tumor is located and help slow down or stop glioblastoma cancer cells from dividing. These transducer arrays are applied to the scalp and are connected to the wearable and portable device. The aim of this study is to collect real life data on the use of tumor-treating fields (TTFields) in patients with newly diagnosed GBM in routine clinical care in Germany.
Who can participate?
Patients aged 18 and older who have GBM
What does the study involve?
This study is a chart review study. Participants who receive TTFields treatment have data collected about their care for 24 months. Data is collected about their health and any serious adverse events that occurred during their care. Participants complete a quality of life questionnaire and questionnaire about TTFields at baseline and during their follow up treatment.
What are the possible benefits and risks of participating?
There are no direct benefits or risks with participating
Where is the study run from?
This study is being run from 5 hospitals in Germany
When is the study starting and how long is it expected to run for?
July 2017 to February 2020
Who is funding the study?
Novocure GmbH (Germany)
Who is the main contact?
1. Ms Frieda Zweynert
2. Dr Oliver Bähr
Ms Frieda Zweynert
CRI – The Clinical Research Institute GmbH
+49 (0)89 990 1649 968
Dr Oliver Bähr
Dr. Senckenbergisches Institut für Neuroonkologie
Schleusenweg 2 - 16
Frankfurt am Main
TTFields In GErmany in Routine clinical care (TIGER): the use of TTFields for newly diagnosed GBM patients in Germany in routine clinical care
The purpose of this post-authorisation medical device study is to obtain real life data on the use of tumor-treating fields (TTFields) in patients with newly diagnosed GBM in routine clinical care in Germany.
Ethikkommission des FB Medizin der J.W. Goethe-Universität, 23/08/2017, ref: 280/17
Multicentre prospective non-interventional observational post-authorisation medical device study
Primary study design
Secondary study design
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
This is non-interventional study evaluating use of tumor-treating fields (TTFields) in newly diagnosed glioblastoma (GBM) patients in routine clinical care. TTFields help slow down or stop glioblastoma cancer cells from dividing by disrupting dividing mechanism of cancer cells leading to apoptosis. TTFields are low-intensity, intermediate frequency, alternating electric fields delivered continuously through adhesive patches, called transducer arrays, to the area of the brain where the GBM tumor is located. These transducer arrays are applied to the scalp and are connected to the wearable and portable device. TTFields are approved for the treatment of newly diagnosed and recurrent GBM.
Eligible participants are enrolled in the study after signing informed consent to use their data and process it centrally for research purposes. Participants do not experience any tests or procedures that are not part of routine clinical care. For patients refusing TTFields treatment at baseline only baseline data is collected. Patient who initiate TTFields Therapy are followed-up during the first 24 months after study enrolment, LPI has a max. of 18 months follow-up.
Data obtained from patient files: Only data which can be obtained from routine clinical care files of the patients is recorded. Data of each routine clinical care visit during the first 24 months after study enrolment is reported in the eCRF. Data is derived from clinical records and findings, radiological assessments (e.g. contrast enhanced MRI), observations or other sources (e.g. hospital records, clinical and office charts, electronic patient records, laboratory notes, recorded data from automated device). Serious Adverse Events (SAEs) are documented during follow-up visits by the treating investigator and subsequently centrally assessed by an independent Clinical Event Committee.
Participants also complete quality of life questionnaires and a study-specific questionnaire on TTFields at baseline and during follow-up.
Primary outcome measures
1. Time to death of any cause (overall survival [OS]) from diagnosis is measured using the patient data from date of enrollment until the date of death from any cause
2. Number of TTFields treatment-related (serious adverse events) SAEs standardised to one year of FU is measured using the collection of SAEs during the follow-up period
3. Number of SAEs after start of TTFields treatment is measured using the collection of SAEs at the follow-up period
4. Time of usage (compliance) of TTFields treatment over time is measured using the treatment compliance report at the follow-up period
5. Time to first progression of GBM (progression-free survival [PFS]), defined within radiological and/or clinical/neurological assessment during routine clinical care in patients who started TTFields treatment at baseline from date of enrollment until the date of first progression of GBM
6. Changes in quality of life after start of TTFields treatment compared to baseline in patients who started TTFields treatment at baseline is measured using the QoL questionnaires at months two and four after start of TTFields treatment
7. Patients' reason(s) for refusing TTFields is measured using a questionnaire at baseline
Secondary outcome measures
There are no secondary outcome measures
Overall trial start date
Overall trial end date
Participant inclusion criteria
1. Newly diagnosed histologically confirmed GBM (WHO-Grade IV)
2. Patient within first 3 cycles of first-line tumor-specific maintenance chemotherapy
3. ≥ 18 years of age
4. Clinical indication for TTFields treatment
5. Given informed consent for use and processing of data
Target number of participants
Participant exclusion criteria
1. Present or planned pregnancy
2. Significant additional neurological disease (e.g. significantly increased intracerebral pressure (ICP) with a significant midline shift of the brain)
3. Active implanted medical device (e.g. deep brain stimulator)
4. Documented allergy to conductive hydrogel
5. Skull defect (e.g. missing bone with no replacement, bullet fragments in the skull)
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
University Hospital Frankfurt
Frankfurt am Main
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal, intent to publish date is end of year 2020.
IPD sharing statement:
The datasets generated during and/or analysed during the current study is not expected to be made available due to data protection.
Intention to publish date
Participant level data
Not expected to be available
Results - basic reporting