TTFields in General Routine Clinical Care in Patients With Pleural Mesothelioma Study

Recruiting

• Conditions: Pleural Mesothelioma
• Interventions: Device: TTFields

• Registration Number: NCT05538806
• Lead Sponsor: NovoCure GmbH

Brief Summary

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 pleural mesothelioma in routine clinical care. Patients with pleural mesothelioma and clinical indication for TTFields treatment will be enrolled in the study after signing Informed consent to use their data and process it centrally for research purposes. The clinical indication for TTFields is one of the inclusion criteria and is defined prior to inclusion by the treating physician.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-06
• Study First Submitted QC: 2022-09-09
• Study First Posted: 2022-09-14
• Study Start: 2023-08-01
• Status Verified: 2024-12
• Last Update Submitted: 2025-03-27
• Last Update Posted: 2025-04-02
• Primary Completion: 2027-12
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 198

Inclusion Criteria

• ≥ 18 years of age
• Histologically confirmed pleural mesothelioma without any option of curative resection
• Planned treatment with NovoTTF-200T System according to IFU and medical guidelines
• Life expectancy more than 3 months at day of enrollment
• Signed informed consent for use and processing of data

Exclusion Criteria

• Previous treatment with NovoTTF-200T for more than 1 week at day of enrollment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	TTFields	all patients will receive routine clinical care and TTFields

Primary Outcome Measures

Name	Time	Method
Time from diagnosis of pleural mesothelioma to death of any cause as median overall survival time.	54 Months

Secondary Outcome Measures

Name	Time	Method
Changes in quality of life comparing baseline with 3 and 6 months after start of TTFields therapy.	QoL will be assessed at baseline, 3 and 6 months.
Number of TTFields treatment-related SAEs, as assessed by the CEC, within total observation period, standardized to average annual incidences.	3 years + 18 months follow up

Trial Locations

Locations (22)

Kliniken der Stadt Koeln; 🇩🇪 Cologne, Germany

Florence-Nightingale-Hospital; 🇩🇪 Düsseldorf, Germany

Klinikum Essen-Mitte; 🇩🇪 Essen, Germany

University Hospital Essen; 🇩🇪 Essen, Germany

Niels-Stensen Hospital; 🇩🇪 Georgsmarienhütte, Germany

Krankenhaus Martha-Maria Halle-Doelau; 🇩🇪 Halle, Germany

Lungenklinik Hemer; 🇩🇪 Hemer, Germany

Evangelisches Krankenhaus Herne; 🇩🇪 Herne, Germany

Krankenhaus Bethanien Moers; 🇩🇪 Moers, Germany

GEHO Muenster; 🇩🇪 Muenster, Germany

Fachkliniken Wangen; 🇩🇪 Wangen, Germany

Azienda Ospedaliero-Universitaria di Alessandria "SS. Antonio e Biagio e C. Arrigo"; 🇮🇹 Alessandria, Italy

Humanitas Gavazzeni; 🇮🇹 Bergamo, Italy

Erasmus MC Cancer Centre; 🇳🇱 Rotterdam, Netherlands

Medizinische Hochschule Hannover; 🇩🇪 Hannover, Germany

Lungenklinik Gauting; 🇩🇪 Gauting, Bavaria, Germany

University Hospital Regensburg; 🇩🇪 Regensburg, Bavaria, Germany

Asklepios Klinikum Harburg; 🇩🇪 Hamburg-Harburg, Hamburg, Germany

University Hospital Carl Gustav Carus Dresden; 🇩🇪 Dresden, Saxony, Germany

Charité Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

Lungenklinik Heckeshorn; 🇩🇪 Berlin, Germany

Klinikum Bremen-Ost; 🇩🇪 Bremen, Germany