TTFields in General Routine Clinical Care in Patients With Pleural Mesothelioma Study
ConditionPleural Mesothelioma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNovoCure Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥ 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
Disqualifiers
None
Trial population
Adult, histologically confirmed pleural mesothelioma without any option of curative resection
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
TTFields
Deviceall patients will receive routine clinical care and TTFields
Treatment groups
198 Participants
are divided into 1 treatment groupGroup A: Group 11 intervention
Trial outcomes
Primary outcomes
1
Time from diagnosis of pleural mesothelioma to death of any cause as median overall survival time.
Time frame
54 MonthsSecondary outcomes
1
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 up2
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov