Recruiting Clinical Trials

Intracavitary Cisplatin-Fibrin Localized Chemotherapy After P/D or EPP for Malignant Pleural Mesothelioma

By April 24, 2017 No Comments

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

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