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

Pleural Mesothelioma Clinical Trial

— TIGER Meso  

Official title:

TTFields in General Routine Clinical Care in Patients With Pleural Mesothelioma Study - TIGER Meso Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05538806
• Other study ID #: CIP-RS-001
• Status: Recruiting
• Start date: August 1, 2023
• Est. completion date: March 31, 2028

Study information

• Verified date: May 2024
• Source: NovoCure Ltd.
• Contact: Giovanni Ceresoli
• Phone: +392 9626717
• Email: giovanni.ceresoli[@]mc.humanitas.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 198
• Est. completion date: March 31, 2028
• Est. primary completion date: September 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mesothelioma
• Mesothelioma, Malignant
• Pleural Mesothelioma

Intervention

Device:
• TTFields
all patients will receive routine clinical care and TTFields

Locations

Country	Name	City	State
Germany	Lungenklinik Heckeshorn	Berlin
Germany	Klinikum Bremen-Ost	Bremen
Germany	Kliniken der Stadt Koeln	Cologne
Germany	University Hospital Carl Gustav Carus Dresden	Dresden	Saxony
Germany	Klinikum Essen-Mitte	Essen
Germany	University Hospital Essen	Essen
Germany	Lungenklinik Gauting	Gauting	Bavaria
Germany	Krankenhaus Martha-Maria Halle-Doelau	Halle
Germany	Asklepios Klinikum Harburg	Hamburg-Harburg	Hamburg
Germany	Lungenklinik Hemer	Hemer
Germany	Krankenhaus Bethanien Moers	Moers
Germany	University Hospital Regensburg	Regensburg	Bavaria
Germany	Fachkliniken Wangen	Wangen
Italy	Azienda Ospedaliero-Universitaria di Alessandria "SS. Antonio e Biagio e C. Arrigo"	Alessandria
Italy	Humanitas Gavazzeni	Bergamo
Netherlands	Erasmus MC Cancer Centre	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
NovoCure GmbH

Countries where clinical trial is conducted

Germany,  Italy,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time from diagnosis of pleural mesothelioma to death of any cause as median overall survival time.		54 Months
Secondary	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
Secondary	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.