Trimodality Therapy for Malignant Pleural Mesothelioma

Trimodality Therapy for Malignant Pleural Mesothelioma: Radical Pleurectomy, Followed by Adjuvant Chemotherapy With Cisplatin/Pemetrexed and Radiotherapy

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.

Study Overview

• Status: Unknown
• Conditions: Malignant Pleural Mesothelioma

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Germany
  • Wiesbaden, Germany
    • Recruiting
    • Dr. Horst Schmidt Klinik, Department of Thoracic Surgery
    • Contact: Joachim Schirren, MD, PhD; Phone Number: +49 611 433132; Email: joachim.schirren@hsk-wiesbaden.de
    • Principal Investigator: Joachim Schirren, MD, PhD
    • Sub-Investigator: Servet Bölükbas, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with malignant pleural mesothelioma prsentint at the Deparment of Thoracic Surgery, HSK Wiesbaden

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To determine the overall 5-year survival rate.	5-years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: HSK Wiesbaden
• Investigators: Principal Investigator: Joachim Schirren, MD, PhD, HSK Wiesbaden

Study record dates

Study Major Dates

• Study Start: November 1, 2002
• Primary Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: April 5, 2011
• First Submitted That Met QC Criteria: April 26, 2011
• First Posted (Estimate): April 28, 2011

Study Record Updates

• Last Update Posted (Estimate): April 28, 2011
• Last Update Submitted That Met QC Criteria: April 26, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: Cisplatin; Pemetrexed; Radiation; Radical Pleurectomy; Pleurectomy/decortication
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Lung Diseases; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Adenoma; Neoplasms, Mesothelial; Pleural Neoplasms; Mesothelioma; Mesothelioma, Malignant
• Other Study ID Numbers: RP2002-01