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Trimodality Therapy for Malignant Pleural Mesothelioma
Conditions
Malignant Pleural Mesothelioma
Conditions: official terms
Mesothelioma
Conditions: Keywords
Radical Pleurectomy, Pleurectomy/decortication, Cisplatin, Pemetrexed, Radiation
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Overall Status
Recruiting
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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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.
- 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.
Location
Dr. Horst Schmidt Klinik, Department of Thoracic Surgery
Wiesbaden, Germany
Status: Recruiting
Contact: Joachim Schirren, MD, PhD - +49 611 433132 - joachim.schirren@hsk-wiesbaden.de
Start Date
November 2002
Sponsors
HSK Wiesbaden
Source
HSK Wiesbaden
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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