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Spots Global Cancer Trial Database for TIGER PRO-Active - Daily Activity, Sleep and Neurocognitive Functioning Study

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Trial Identification

Brief Title: 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 ID: NCT04717739

Conditions

Glioblastoma

Interventions

TTFields

Study Description

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

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Universitätsklinikum Aachen, Aachen, , Germany

Klinikum Aschaffenburg-Alzenau, Aschaffenburg, , Germany

Universitätsklinikum Augsburg (AöR), Augsburg, , Germany

Universitätsklinikum Bonn, Bonn, , Germany

Klinikum Chemnitz, Chemnitz, , Germany

Carl-Thiem-Klinikum Cottbus, Cottbus, , Germany

Universitätsklinik Carl Gustav Carus Dresden, Dresden, , Germany

Sana Kliniken Duisburg, Duisburg, , Germany

Universitätsklinikum Düsseldorf HHU, Düsseldorf, , Germany

HELIOS Klinikum Erfurt, Erfurt, , Germany

Universitätsklinikum Erlangen, Erlangen, , Germany

Universitätsklinikum Essen, Essen, , Germany

Universitätsklinikum Frankfurt Goethe-Universität, Frankfurt, , Germany

Universitätsmedizin Greifswald, Greifswald, , Germany

BG Klinikum Bergmannstrost Halle, Halle, , Germany

Onkologische Schwerpunktpraxis Dres. I. Zander und E. von der Heyde, Hannover, , Germany

Medizinische Hochschule Hannover, Hannover, , Germany

Universitätsklinikum des Saarlandes, Homburg, , Germany

Universitätsklinikum Jena, Jena, , Germany

Klinikum Kassel, Kassel, , Germany

Universitätsklinikum SH Campus Kiel, Kiel, , Germany

Uniklinik Köln, Köln, , Germany

Kliniken der Stadt Köln GmbH, Köln, , Germany

Otto-von-Guericke-Universität Magdeburg, Magdeburg, , Germany

Med. Fakultät Mannheim der Universität Heidelberg, Mannheim, , Germany

Johannes Wesling Klinikum Minden, Minden, , Germany

Kliniken Maria Hilf GmbH, Mönchengladbach, , Germany

Klinikum Nürnberg, Nürnberg, , Germany

Pius-Hospital Oldenburg, Oldenburg, , Germany

Niels-Stensen-Kliniken - Marienhospital Osnabrück, Osnabrück, , Germany

Universitätsmedizin Rostock, Rostock, , Germany

HELIOS Kliniken Schwerin GmbH, Schwerin, , Germany

Johanniter-Krankenhaus Genthin-Stendal GmbH, Stendal, , Germany

Klinikum Stuttgart, Stuttgart, , Germany

Universitätsklinikum Tübingen, Tübingen, , Germany

Paracelsus-Klinik Zwickau, Zwickau, , Germany

Contact Details

Name: Martin Glas, Prof.

Affiliation: University hospital Essen, Essen, Germany

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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