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