TTFields In Germany in routine clinical care
| ISRCTN | ISRCTN14267833 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14267833 |
| ClinicalTrials.gov number | NCT03258021 |
| Secondary identifying numbers | 05.07.2017 |
- Submission date
- 27/07/2017
- Registration date
- 08/08/2017
- Last edited
- 21/02/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
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 August 2022
Who is funding the study?
Novocure GmbH (Germany)
Who is the main contact?
1. Dunja Kosanovic
tiger@cri-muc.eu
2. Prof. Dr Oliver Bähr
Contact information
Public
CRI – The Clinical Research Institute GmbH
Arnulfstraße 19
Munich
80335
Germany
| Phone | +49 (0)89 990 1649 968 |
|---|---|
| tiger@cri-muc.eu |
Scientific
Clinical Centre Aschaffenburg-Alzenau gGmbH
Neurologic Clinic
Am Hasenkopf 1
Aschaffenburg
63739
Germany
 ORCID ID |
0000-0003-2073-037X |
|---|
Study information
| Study design | Multicentre prospective non-interventional observational post-authorisation medical device study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| 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 |
| Study acronym | TIGER |
| Study objectives | 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(s) | Ethikkommission des FB Medizin der J.W. Goethe-Universität, 23/08/2017, ref: 280/17 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 05/07/2017 |
| Completion date | 31/08/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | About 1000 |
| Total final enrolment | 709 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 31/08/2017 |
| Date of final enrolment | 30/11/2019 |
Locations
Countries of recruitment
- Germany
Study participating centre
63739
Germany
Sponsor information
Industry
Elektrastraße 6
Munich
81925
Germany
"ROR" |
https://ror.org/04pspdc11 |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 30/04/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to data protection. |
Editorial Notes
21/02/2023: The overall end date was changed from 30/09/2021 to 31/08/2022.
23/06/2021: Contact details updated, ClinicalTrials.gov number added.
22/06/2021: The following changes were made to the trial record:
1. The overall trial end date was changed from 30/06/2021 to 30/09/2021.
2. The intention to publish date was changed from 31/01/2022 to 30/04/2022.
3. Total final enrolment added.
06/07/2020: The primary contact was changed.
01/04/2020: The plain English summary was updated to reflect the changes of 27/02/2020.
27/02/2020: The following changes were made to the trial record:
1. The public contact was updated.
2. The recruitment end date was changed from 31/07/2019 to 30/11/2019.
09/05/2019: Contact details and trial participating centre updated.
22/10/2018: The following changes have been made to the trial record:
1. The overall trial end date has been changed from 29/02/2020 to 30/06/2021
2. The recruitment end date has been changed from 31/08/2018 to 31/07/2019
3. The plain English summary has been updated to reflect the new trial end date
4. The intention to publish date has been changed from 31/12/2020 to 31/01/2022
18/05/2018: The trial centres at Erlangen, Essen, Cologne and Tübingen have been removed.
25/08/2017: Ethics approval details added.
