Trimodality Therapy for Malignant Pleural Mesothelioma
Recruitment status was: Recruiting
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.
Malignant Pleural Mesothelioma
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Trimodality Therapy for Malignant Pleural Mesothelioma: Radical Pleurectomy, Followed by Adjuvant Chemotherapy With Cisplatin/Pemetrexed and Radiotherapy|
- To determine the overall 5-year survival rate. [ Time Frame: 5-years ] [ Designated as safety issue: Yes ]
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]Morbidity
- Number of Participants with treatment related deaths as a Measure of Safety and Tolerability [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]Mortality
- Recurrence [ Time Frame: 5 years ] [ Designated as safety issue: No ]Occurence of tumor recurrence
|Study Start Date:||November 2002|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01343264
|Dr. Horst Schmidt Klinik, Department of Thoracic Surgery|
|Principal Investigator:||Joachim Schirren, MD, PhD||HSK Wiesbaden|