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Trimodality Therapy for Malignant Pleural Mesothelioma

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ClinicalTrials.gov Identifier: NCT01343264
Recruitment Status : Unknown
Verified April 2011 by HSK Wiesbaden.
Recruitment status was:  Recruiting
First Posted : April 28, 2011
Last Update Posted : April 28, 2011
Sponsor:
Information provided by:
HSK Wiesbaden

Study Description
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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.


Condition or disease
Malignant Pleural Mesothelioma

Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
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
Study Start Date : November 2002
Estimated Primary Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. To determine the overall 5-year survival rate. [ Time Frame: 5-years ]

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

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

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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01343264


Locations
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Germany
Dr. Horst Schmidt Klinik, Department of Thoracic Surgery Recruiting
Wiesbaden, Germany
Contact: Joachim Schirren, MD, PhD    +49 611 433132    joachim.schirren@hsk-wiesbaden.de   
Principal Investigator: Joachim Schirren, MD, PhD         
Sub-Investigator: Servet Bölükbas, MD, PhD         
Sponsors and Collaborators
HSK Wiesbaden
Investigators
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Principal Investigator: Joachim Schirren, MD, PhD HSK Wiesbaden
More Information
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Responsible Party: Prof. Dr. Joachim Schirren, HSK Wiesbaden
ClinicalTrials.gov Identifier: NCT01343264    
Other Study ID Numbers: RP2002-01
First Posted: April 28, 2011    Key Record Dates
Last Update Posted: April 28, 2011
Last Verified: April 2011
Keywords provided by HSK Wiesbaden:
Radical Pleurectomy
Pleurectomy/decortication
Cisplatin
Pemetrexed
Radiation
Additional relevant MeSH terms:
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Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial