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
tiger@cri-muc.eu
2. Dr Oliver Bähr
Trial website
Contact information
Type
Public
Primary contact
Ms Frieda Zweynert
ORCID ID
Contact details
CRI – The Clinical Research Institute GmbH
Arnulfstrasse 19
Munich
80335
Germany
+49 (0)89 990 1649 968
tiger@cri-muc.eu
Type
Scientific
Additional contact
Dr Oliver Bähr
ORCID ID
http://orcid.org/0000-0003-2073-037X
Contact details
Dr. Senckenbergisches Institut für Neuroonkologie
Universitätsklinikum Frankfurt
Schleusenweg 2 - 16
Frankfurt am Main
60528
Germany
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
05.07.2017
Study information
Scientific title
TTFields In GErmany in Routine clinical care (TIGER): the use of TTFields for newly diagnosed GBM patients in Germany in routine clinical care
Acronym
TIGER
Study hypothesis
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.
Ethics approval
Ethikkommission des FB Medizin der J.W. Goethe-Universität, 23/08/2017, ref: 280/17
Study design
Multicentre prospective non-interventional observational post-authorisation medical device study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
Glioblastoma
Intervention
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.
Intervention type
Other
Phase
Drug names
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
05/07/2017
Overall trial end date
29/02/2020
Reason abandoned
Eligibility
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
About 1000
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
31/08/2017
Recruitment end date
31/08/2018
Locations
Countries of recruitment
Germany
Trial participating centre
University Hospital Frankfurt
Frankfurt am Main
60528
Germany
Funders
Funder type
Industry
Funder name
Novocure GmbH
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
31/12/2020
Participant level data
Not expected to be available
Results - basic reporting
Publication summary