Condition category
Cancer
Date applied
27/07/2017
Date assigned
08/08/2017
Last edited
25/08/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Trial participating centre

University Hospital Erlangen
Erlangen
91012
Germany

Trial participating centre

University Hospital Essen
Essen
45147
Germany

Trial participating centre

University Hospital Cologne
Cologne
50937
Germany

Trial participating centre

University Hospital Tübingen
Tübingen
72070
Germany

Sponsor information

Organisation

Novocure GmbH

Sponsor details

Elektrastraße 6
Munich
81925
Germany

Sponsor type

Industry

Website

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

Publication citations

Additional files

Editorial Notes

25/08/2017: Ethics approval details added.