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Trimodality Therapy for Malignant Pleural Mesothelioma

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2011 by HSK Wiesbaden.
Recruitment status was:  Recruiting
Information provided by:
HSK Wiesbaden Identifier:
First received: April 5, 2011
Last updated: April 26, 2011
Last verified: April 2011

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 Type: Observational
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

Resource links provided by NLM:

Further study details as provided by HSK Wiesbaden:

Primary Outcome Measures:
  • To determine the overall 5-year survival rate. [ Time Frame: 5-years ]

Secondary Outcome Measures:
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 3 months ]

  • Number of Participants with treatment related deaths as a Measure of Safety and Tolerability [ Time Frame: 3 months ]

  • Recurrence [ Time Frame: 5 years ]
    Occurence of tumor recurrence

Estimated Enrollment: 200
Study Start Date: November 2002
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with malignant pleural mesothelioma prsentint at the Deparment of Thoracic Surgery, HSK Wiesbaden

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01343264

Dr. Horst Schmidt Klinik, Department of Thoracic Surgery Recruiting
Wiesbaden, Germany
Contact: Joachim Schirren, MD, PhD    +49 611 433132   
Principal Investigator: Joachim Schirren, MD, PhD         
Sub-Investigator: Servet Bölükbas, MD, PhD         
Sponsors and Collaborators
HSK Wiesbaden
Principal Investigator: Joachim Schirren, MD, PhD HSK Wiesbaden
  More Information

Responsible Party: Prof. Dr. Joachim Schirren, HSK Wiesbaden Identifier: NCT01343264     History of Changes
Other Study ID Numbers: RP2002-01
Study First Received: April 5, 2011
Last Updated: April 26, 2011

Keywords provided by HSK Wiesbaden:
Radical Pleurectomy

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors processed this record on August 21, 2017