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

September 16, 2022

Primary Outcome Measures

Time from diagnosis of pleural mesothelioma to death of any cause as median overall survival time. [ Time Frame: 54 Months ]

Secondary Outcome Measures

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

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

Any foreseeable deviation from the IFU of NovoTTF-200T Device
Previous treatment with NovoTTF-200T for more than 1 week at day of enrollment

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