Clinical trial NCT04717739: TIGER PRO-Active - Daily Activity, Sleep and Neurocognitive Functioning Study
Official title: Use of TTFields in Germany in Routine Clinical Care Study PROgram - Daily Activity, Sleep and Neurocognitive Functioning in Newly Diagnosed Glioblastoma Patients Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glioblastoma
Keywords: Glioblastoma
GBM
Tumor Treating Fields
TTFields
ePRO
Lead sponsor: NovoCure Ltd.
Sponsor class: INDUSTRY
First posted: 2021-01-22
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with newly diagnosed, histologically confirmed GBM and an indication for treatment with NovoTTF-200A System (Optune®) according to IFU and medical guidelines will be enrolled. Patients' written informed consent to use their routine clinical data and app-based monitoring data according to data privacy standards must be obtained prior to documentation of patients' data in the e-CRF.

Brief summary: This non-interventional study aims to investigate change over time in cognitive function, sleep quality, and activity in daily life as important determinants of QoL in a large cohort of GBM patients in Germany treated with TTFields in routine clinical care using low-threshold, electronic PRO and modern automated tracking data analyses. The gained results will allow even better understanding of TTFields therapy in daily life of GBM patients and consequently, better informing patients about what to expect when starting this therapy, increasing therapy compliance in the long-term.

Detailed description: Glioblastoma (GBM) is the most common malignant primary tumor of the brain with an annual incidence of approximately 3/100.000. Since 2005 the treatment for newly diagnosed GBM consisted of maximal surgical resection, approx. 60 Gy of radiotherapy together with chemotherapy using temozolomide (TMZ), followed by 6 cycles of maintenance chemotherapy. This treatment regimen demonstrated increased median overall survival (OS) from 12.1 to 14.6 months in comparison to surgery and radiotherapy alone in 2005.

Since 2005, despite plenty of clinical phase III trials conducted, Tumor Treating Fields (TTFields) therapy was the first treatment shown to significantly increase median progression-free survival (PFS), OS and one to five year survival rates compared to the previous standard of care. These results led to FDA approval of TTFields for newly diagnosed GBM and were acknowledged since then by several guidelines recommending TTFields for GBM therapy (e.g. NCCN guidelines for CNS cancers V.1.2018, RCC guideline tumörer I hjärna och ryggmärg 2020-01-14 V3.0, DGHO guideline for glioma in adults ICD-10 C71 March 2019). Today, several national committees in Europe already list TTFields as reimbursed treatment (e.g. Austria, Sweden, Germany).

Data with TTFields therapy in real-world setting is limited and therefore further evaluation of different treatment aspects of TTFields therapy in clinical routine are of interest. In particular the QoL-related aspects neurocognitive functioning, daily activity and sleep quality in this patient cohort is of major interest, given the limited life expectancy with this disease.

This non-interventional study aims to investigate change over time in neurocognitive functioning, sleep quality, and activity in daily life as important determinants of QoL in a large cohort of GBM patients in Germany treated with TTFields in routine clinical care using low-threshold, electronic PRO and modern automated tracking data analyses. The gained results will allow even better understanding of TTFields therapy in daily life of GBM patients and consequently, better informing patients about what to expect when starting this therapy, increasing therapy compliance even further in the long-term.

Eligibility criteria: Inclusion Criteria:

* min.18 years of age
* Newly diagnosed, histologically confirmed GBM
* Patient after completion of radiochemotherapy but within first 3 cycles of first-line tumor-specific maintenance chemotherapy
* Clinical indication of treatment with NovoTTF-200A System (Optune®) according to IFU and medical guidelines
* Signed informed consent

Exclusion Criteria:

Any foreseeable deviation from the IFU of NovoTTF-200T Device

Primary outcomes:
measure: Time of usage of TTFields treatment in follow-up derived from monitoring data of the devices, standardised to usage days, as measure of compliance with TTFields treatment.
timeFrame: through study completion, an average of 18 months (mean follow-up time)
measure: Number of TTFields treatment-related SAEs as assessed by the CEC standardized to one year of FU time
timeFrame: through study completion, an average of 18 months (mean follow-up time)
measure: Changes in daily physical activity as a potential quality of life parameter in TTFields treatment compared to baseline for up to four months after start of TTFields therapy
timeFrame: Up to 4 months after start of TTFields treatment compared to baseline
measure: Changes in sleep quality as a potential quality of life parameter in TTFields treatment compared to baseline for up to four months after start of TTFields therapy
timeFrame: Up to 4 months after start of TTFields treatment compared to baseline
measure: Changes in neurocognitive functioning as a potential quality of life parameter in TTFields treatment compared to baseline for up to four months after start of TTFields therapy.
timeFrame: Up to 4 months after start of TTFields treatment compared to baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen
city: Aschaffenburg
country: Germany
facility: Klinikum Aschaffenburg-Alzenau
city: Augsburg
country: Germany
facility: Universitätsklinikum Augsburg (AöR)
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz
city: Cottbus
country: Germany
facility: Carl-Thiem-Klinikum Cottbus
city: Dresden
country: Germany
facility: Universitätsklinik Carl Gustav Carus Dresden
city: Duisburg
country: Germany
facility: Sana Kliniken Duisburg
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf HHU
city: Erfurt
country: Germany
facility: HELIOS Klinikum Erfurt
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt Goethe-Universität
city: Greifswald
country: Germany
facility: Universitätsmedizin Greifswald
city: Halle
country: Germany
facility: BG Klinikum Bergmannstrost Halle
city: Hannover
country: Germany
facility: Onkologische Schwerpunktpraxis Dres. I. Zander und E. von der Heyde
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Homburg
country: Germany
facility: Universitätsklinikum des Saarlandes
city: Jena
country: Germany
facility: Universitätsklinikum Jena
city: Kassel
country: Germany
facility: Klinikum Kassel
city: Kiel
country: Germany
facility: Universitätsklinikum SH Campus Kiel
city: Köln
country: Germany
facility: Uniklinik Köln
city: Köln
country: Germany
facility: Kliniken der Stadt Köln GmbH
city: Magdeburg
country: Germany
facility: Otto-von-Guericke-Universität Magdeburg
city: Mannheim
country: Germany
facility: Med. Fakultät Mannheim der Universität Heidelberg
city: Minden
country: Germany
facility: Johannes Wesling Klinikum Minden
city: Mönchengladbach
country: Germany
facility: Kliniken Maria Hilf GmbH
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg
city: Oldenburg
country: Germany
facility: Pius-Hospital Oldenburg
city: Osnabrück
country: Germany
facility: Niels-Stensen-Kliniken - Marienhospital Osnabrück
city: Rostock
country: Germany
facility: Universitätsmedizin Rostock
city: Schwerin
country: Germany
facility: HELIOS Kliniken Schwerin GmbH
city: Stendal
country: Germany
facility: Johanniter-Krankenhaus Genthin-Stendal GmbH
city: Stuttgart
country: Germany
facility: Klinikum Stuttgart
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Zwickau
country: Germany
facility: Paracelsus-Klinik Zwickau
Study officials:
affiliation: University hospital Essen, Essen, Germany
name: Martin Glas, Prof.
role: PRINCIPAL_INVESTIGATOR
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