TIGER PRO-Active - Daily Activity, Sleep and Neurocognitive Functioning Study
Rekrutierend
NCT-Nummer:
NCT04717739
Studienbeginn:
Dezember 2021
Letztes Update:
10.01.2023
Wirkstoff:
-
Indikation (Clinical Trials):
Glioblastoma
Geschlecht:
Alle
Altersgruppe:
Erwachsene (18+)
Phase:
-
Sponsor:
NovoCure Ltd.
Collaborator:
-
Studienleiter
Martin Glas, Prof. Principal InvestigatorUniversity hospital Essen, Essen, Germany
Kontakt
Dunja Kosanovic Kontakt: Phone: 0049 89 990 1649 968 E-Mail: tigerpro@cri-muc.eu» Kontaktdaten anzeigen
Studienlocations (3 von 36)
Aachen Germany Aschaffenburg Bayern Augsburg Bonn Nordrhein-Westfalen Chemnitz Deutschland Cottbus Dresden Sachsen Duisburg Düsseldorf Erfurt Thüringen Erlangen Essen Frankfurt Hessen Greifswald Mecklenburg-Vorpommern Halle Sachsen-Anhalt Hannover Niedersachsen Homburg Jena Kassel Kiel Schleswig-Holstein Köln Magdeburg Mannheim Baden-Württemberg Minden Mönchengladbach Nürnberg Oldenburg Osnabrück Rostock Schwerin Stendal Stuttgart Tübingen Zwickau
Universitätsklinikum Aachen 52074 Aachen GermanyAktiv, nicht rekrutierend » Google-Maps Klinikum Aschaffenburg-Alzenau 63739 Aschaffenburg (Bayern) GermanyRekrutierend » Google-Maps Ansprechpartner: Giles Vince, Prof. » Ansprechpartner anzeigen Universitätsklinikum Augsburg (AöR) 86156 Augsburg (Bayern) GermanyRekrutierend » Google-Maps Ansprechpartner: Ehab Shiban, Prof. » Ansprechpartner anzeigen Universitätsklinikum Bonn 53127 Bonn (Nordrhein-Westfalen) GermanyAktiv, nicht rekrutierend » Google-Maps Darmkrebszentrum Klinikum Chemnitz Flemmingstraße 2 9116 Chemnitz DeutschlandAktiv, nicht rekrutierend » Google-Maps Pankreaskarzinomzentrum im Carl-Thiem-Klinikum Cottbus Thiemstraße 111 3048 Cottbus DeutschlandRekrutierend » Google-Maps Ansprechpartner: Carsten Schoof, Dr. » Ansprechpartner anzeigen Universitätsklinik Carl Gustav Carus Dresden 01307 Dresden (Sachsen) GermanyRekrutierend » Google-Maps Ansprechpartner: Dietmar Krex, Prof. » Ansprechpartner anzeigen Sana Kliniken Duisburg 47055 Duisburg (Nordrhein-Westfalen) GermanyAktiv, nicht rekrutierend » Google-Maps Universitätsklinikum Düsseldorf HHU 40225 Düsseldorf (Nordrhein-Westfalen) GermanyAktiv, nicht rekrutierend » Google-Maps HELIOS Klinikum Erfurt 99089 Erfurt (Thüringen) GermanyRekrutierend » Google-Maps Ansprechpartner: Rüdiger Gerlach, Prof. » Ansprechpartner anzeigen Hautkrebszentrum Universitätsklinikum Erlangen Ulmenweg 18 91054 Erlangen (Bayern) DeutschlandRekrutierend » Google-Maps Ansprechpartner: Rainer Fietkau, Prof. » Ansprechpartner anzeigen Kinderonkologisches Zentrum Universitätsklinikum Essen Hufelandstraße 55 45147 Essen DeutschlandRekrutierend » Google-Maps Ansprechpartner: Sied Kebir, Dr. » Ansprechpartner anzeigen Universitätsklinikum Frankfurt Goethe-Universität 60528 Frankfurt (Hessen) GermanyAktiv, nicht rekrutierend » Google-Maps Interdisziplinäres Brustzentrum der Universitätsmedizin Greifswald Ferdinand-Sauerbruch-Straße 17475 Greifswald Greifswald (Mecklenburg-Vorpommern) DeutschlandAktiv, nicht rekrutierend » Google-Maps BG Klinikum Bergmannstrost Halle 06112 Halle (Sachsen-Anhalt) GermanyRekrutierend » Google-Maps Ansprechpartner: Anja Glien, Dr. » Ansprechpartner anzeigen Onkologische Schwerpunktpraxis Dres. I. Zander und E. von der Heyde 30161 Hannover (Niedersachsen) GermanyRekrutierend » Google-Maps Ansprechpartner: Eyck von der Heyde, Dr. » Ansprechpartner anzeigen Leberkrebszentrum Medizinische Hochschule Hannover Carl-Neuberg-Straße 1 30625 Hannover DeutschlandAktiv, nicht rekrutierend » Google-Maps Universitäts-Brustzentrum am Universitätsklinikum des Saarlandes Kirrberger Straße 100 66424 Homburg DeutschlandAktiv, nicht rekrutierend » Google-Maps Universitätsklinikum Jena 07747 Jena (Thüringen) GermanyAktiv, nicht rekrutierend » Google-Maps IBZ - Interdisziplinäres Brustzentrum am Klinikum Kassel Mönchebergstraße 41-43 34125 Kassel (Hessen) DeutschlandAktiv, nicht rekrutierend » Google-Maps Universitätsklinikum SH Campus Kiel 24105 Kiel (Schleswig-Holstein) GermanyRekrutierend » Google-Maps Ansprechpartner: Hajrullah Ahmeti, Dr. » Ansprechpartner anzeigen Lungenkrebszentrum Uniklinik Köln / Solingen Kerpener Straße 62 50937 Köln DeutschlandAktiv, nicht rekrutierend » Google-Maps Kliniken der Stadt Köln GmbH 51109 Köln (Nordrhein-Westfalen) GermanyAktiv, nicht rekrutierend » Google-Maps Otto-von-Guericke-Universität Magdeburg 39120 Magdeburg (Sachsen-Anhalt) GermanyAktiv, nicht rekrutierend » Google-Maps Med. Fakultät Mannheim der Universität Heidelberg 68167 Mannheim (Baden-Württemberg) GermanyAktiv, nicht rekrutierend » Google-Maps Johannes Wesling Klinikum Minden 32429 Minden (Nordrhein-Westfalen) GermanyAktiv, nicht rekrutierend » Google-Maps Darmzentrum der Kliniken Maria Hilf GmbH Mönchengladbach Sandradstraße 43 41061 Mönchengladbach DeutschlandRekrutierend » Google-Maps Ansprechpartner: Ursula Nestle, Prof. » Ansprechpartner anzeigen Interdisziplinäres Brustzentrum Klinikum Nürnberg Prof.-Ernst-Nathan-Straße 1 90419 Nürnberg (Bayern) DeutschlandAktiv, nicht rekrutierend » Google-Maps Pius-Hospital Oldenburg 26121 Oldenburg (Niedersachsen) GermanyAktiv, nicht rekrutierend » Google-Maps Niels-Stensen-Kliniken - Marienhospital Osnabrück 49076 Osnabrück (Niedersachsen) GermanySchwebend » Google-Maps Pankreaskarzinomzentrum der Universitätsmedizin Rostock Doberaner Straße 137-139 18057 Rostock DeutschlandAktiv, nicht rekrutierend » Google-Maps HELIOS Kliniken Schwerin GmbH 19049 Schwerin (Mecklenburg-Vorpommern) GermanyAktiv, nicht rekrutierend » Google-Maps Johanniter-Krankenhaus Genthin-Stendal GmbH 39576 Stendal (Sachsen-Anhalt) GermanyRekrutierend » Google-Maps Ansprechpartner: Gunnar Lohm, Dr. » Ansprechpartner anzeigen Brustzentrum Klinikum Stuttgart/Frauenklinik Kriegsbergstraße 60 70174 Stuttgart DeutschlandRekrutierend » Google-Maps Ansprechpartner: Daniel Sachs, Dr. » Ansprechpartner anzeigen Viszeralonkologisches Zentrum Universitätsklinikum Tübingen Hoppe-Seyler-Straße 3 72076 Tübingen DeutschlandAktiv, nicht rekrutierend » Google-Maps Paracelsus-Klinik Zwickau 08008 Zwickau (Sachsen) GermanyAktiv, nicht rekrutierend » Google-Maps Alle anzeigen
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.
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 consentExclusion Criteria: Any foreseeable deviation from the IFU of NovoTTF-200T Device
Primary outcome: 1. 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. (Time Frame - through study completion, an average of 18 months (mean follow-up time)):Time of usage (compliance) of TTFields treatment over time is measured using the treatment compliance report at the Follow-up period 2. Number of TTFields treatment-related SAEs as assessed by the CEC standardized to one year of FU time (Time Frame - through study completion, an average of 18 months (mean follow-up time)):Number of TTFields treatment-related SAEs standardized to one year of follow-up (FU) is measured using the collection of SAEs during the follow-up period 3. 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 (Time Frame - Up to 4 months after start of TTFields treatment compared to baseline):Changes in daily physical activity will be assessed by smartphone app-based clinical monitoring. 4. 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 (Time Frame - Up to 4 months after start of TTFields treatment compared to baseline):Changes in sleep quality will be assessed by smartphone app-based clinical monitoring. 5. 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. (Time Frame - Up to 4 months after start of TTFields treatment compared to baseline):Changes in neurocognitive functioning will be assessed by means of MoCA interview tests.
TTFields:Tumor Treating Fields (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.
Quelle: ClinicalTrials.gov
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