Condition
Malignant Pleural Mesothelioma
Estimated Enrollment: 54
Age Group: 18 Years and older (Adult, Senior)
Gender: All
Study Type: Interventional
Study Design Allocation: Intervention Model: Single Group Assignment|Masking: Open Label|Primary Purpose: Treatment
Study ID Numbers: INFLuenCe – Meso
Study First Received: July 17, 2012
Last Updated: May 10, 2016
Estimated Primary Completion Date: August 2020
Primary Outcome Measures:
number of participants with adverse events|local cisplatin concentration in the superficial chest wall tissue by inductively coupled plasma sector field mass spectrometric (ICP-MS) detection|safety blood parameters (hematology and clinical chemistry)|overall survival|FFR freedom from recurrence = time to tumor progression by CT or PET-CT/MRI|change from baseline in SF-36 quality of life questionnaire|change from baseline in EORTC Lung Cancer Questionnaire QLQ-C15/LC13|cisplatin concentration in blood serum by inductively coupled plasma sector field mass spectrometric (ICP-MS) detection|cisplatin concentration in urine by inductively coupled plasma sector field mass spectrometric (ICP-MS) detection|TUNEL assay (markers for apoptosis in superficial chest wall tissue)|PAI-1 and p21 markers for senescence in superficial chest wall tissue|in-treatment-field FFR freedom from recurrence = time to tumor progression by CT or PET-CT/MRI in the chest cavitiy where the IMP was applied
Sponsors and Collaborators:
University of Zurich|Swiss National Science Foundation|Swiss Accident Insurance Fund SUVA
Website Link: https://ClinicalTrials.gov/show/NCT01644994
