Trimodality Therapy for Malignant Pleural Mesothelioma

• Conditions: Malignant Pleural Mesothelioma

• Registration Number: NCT01343264
• Lead Sponsor: HSK Wiesbaden

Brief Summary

The role of surgical resection in the management of Malignant Pleural Mesothelioma (MPM) is still controversial. The selection criterion to perform either Extrapleural Pneumonectomy (EPP) or Pleurectomy/Decortication (P/D) is dependent not only on the cardio-pulmonary status of the patient, tumor stage and intraoperative findings but also on surgeons' decision and philosophy. There are no established guidelines. Radical Pleurectomy (RP) competes against EPP as surgical therapy modality. Both surgical approaches are cytoreductive treatment options. The aim is to remove all gross disease and to achieve macroscopic complete resection.

Originally P/D was a palliative option for controlling pleural effusion. But lung-sparing surgery for MPM seems to be an alternative to patients unsuitable or unwilling to undergo EPP in a multimodality therapy concept. Most studies evaluating multimodality therapies for MPM are based on retrospective analyses and their interpretation is difficult because of inhomogeneous patient groups studied.

The aim of our study was to analyze the feasibility and results of RP as surgical therapy modality in a standardized trimodality therapy concept.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-11
• Status Verified: 2011-04
• Study First Submitted: 2011-04-05
• Study First Submitted QC: 2011-04-26
• Last Update Submitted: 2011-04-26
• Study First Posted: 2011-04-28
• Last Update Posted: 2011-04-28
• Primary Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Histologically confirmed diagnosis of MPM (all subtypes)
• Clinical T1-3, N0-2, M0 disease.
• No prior treatment for MPM.
• Adequate renal and liver function
• Adequate cardio-pulmonary reserves

Exclusion Criteria

• Patients with unresectable disease
• Patients with an active infection that require systemic treatments
• Patients with a concurrent active malignancy.
• Patients with serious medical illness.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the overall 5-year survival rate.	5-years

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	3 months	Morbidity
Number of Participants with treatment related deaths as a Measure of Safety and Tolerability	3 months	Mortality
Recurrence	5 years	Occurence of tumor recurrence

Trial Locations

Locations (1)

Dr. Horst Schmidt Klinik, Department of Thoracic Surgery; 🇩🇪 Wiesbaden, Germany