TIGER Meso study

Pleural mesothelioma is a rare cancer that is commonly associated with asbestos exposure. Due to the aggressiveness of the disease, the prognosis is very poor. Patients can be treated with different combinations of chemotherapy, surgery and radiotherapy as well as immunotherapy. For early stage pleural mesothelioma, various treatment options can be taken into consideration and there is no consensus on the preferred treatment option. Tumor Treating Fields (TTFields) are low-intensity (1-3 V/cm), intermediate frequency (150 KHz for pleural mesothelioma) alternating electric fields that interfere with cell division. TTFields? anti-mitotic mechanism of action is based on disruption of cell spindle-apparatus by interfering with key electrically charged molecules, such as tubulin or septin proteins that are required for the mitotic process. Interference with these key molecules can lead to cell death through multiple pathways. Pre-clinical studies have shown that TTFields are able to effectively inhibit tumor growth, both, in vitro and in vivo without any systemic side effects. In addition, safety of in vivo TTFields application to the torso was confirmed in a more recent study

{ "short_title": "TIGER Meso study", "data_mode": "900", "data_mode_number": "000002392", "official_title": "TTFields in general routine clinical care in patients with pleural mesothelioma study", "accrual_state": "running", "therapeutic_value": "therapeutic", "therapieansatz_value": "not_applicable", "therapieintervention_value": "adjuvant", "therapielinie_value": "not_applicable", "ctgov_number": "NCT0553880", "eudract_number": null, "general_contact_email": "studienzentrum-vtg@ukdd.de", "general_contact_phone": null, "hauptpruefer_dd_name": "Prof. Dr. med. Till Pl\u00f6nes", "description_laie_de": "Diese Beobachtungsstudie untersucht die bei Patientinnen und Patienten mit einem Pleuramesotheliom (Rippenfellkrebs) im Rahmen der klinischen Routineversorgung die Wirksamkeit von TTFields in Kombination mit einer systemischen Chemotherapie zu best\u00e4tigen. Hierzu wird ein kleines, tragbares Ger\u00e4t durchzuf\u00fchren, das elektrische Wechselfelder, sogenannte Tumor Treating Fields (TTFields), erzeugt. Diese TTFields k\u00f6nnen die Teilung von Pleuramesotheliomzellen verlangsamen oder stoppen. TTFields werden gezielt an die sich teilenden Krebszellen im Rippenfell abgegeben und sch\u00e4digen nach heutigem Kenntnisstand keine ruhenden Zellen. Studienergebnisse haben gezeigt, dass TTFields in Kombination mit den Chemotherapeutika Pemetrexed \r\nund Cisplatin oder Carboplatin bei inoperablem Pleuramesotheliom zu einer l\u00e4ngeren Zeit ohne Fortschreiten des Tumors, sowie zu einer l\u00e4ngeren Gesamt\u00fcberlebenszeit f\u00fchrt. Die TTFields-Therapie wird daher als zus\u00e4tzliche Therapie zur systemischen Therapie eingesetzt.", "description_laie_en": null, "description_expert_de": null, "description_expert_en": "Pleural mesothelioma is a rare cancer that is commonly associated with asbestos exposure. Due to the aggressiveness of the disease, the prognosis is very poor. Patients can be treated with different combinations of chemotherapy, surgery and radiotherapy as well as immunotherapy. For early stage pleural mesothelioma, various treatment options can be taken into consideration and there is no consensus on the preferred treatment option. Tumor Treating Fields (TTFields) are low-intensity (1-3 V/cm), intermediate frequency (150 KHz for pleural mesothelioma) alternating electric fields that interfere with cell division. TTFields? anti-mitotic mechanism of action is based on disruption of cell spindle-apparatus by interfering with key electrically charged molecules, such as tubulin or septin proteins that are required for the mitotic process. Interference with these key molecules can lead to cell death through multiple pathways. Pre-clinical studies have shown that TTFields are able to effectively inhibit tumor growth, both, in vitro and in vivo without any systemic side effects. In addition, safety of in vivo TTFields application to the torso was confirmed in a more recent study", "rechtsgrundlage_value": "BO", "phase_amg_value": null, "main_cat_id": 10, "sub_cat_id": 49 }

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