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Trimodality Therapy for Malignant Pleural Mesothelioma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by HSK Wiesbaden.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
HSK Wiesbaden
ClinicalTrials.gov Identifier:
NCT01343264
First received: April 5, 2011
Last updated: April 26, 2011
Last verified: April 2011
History of Changes
  Purpose

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
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:

MedlinePlus related topics: Mesothelioma
U.S. FDA Resources

Further study details as provided by HSK Wiesbaden:

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

Secondary Outcome Measures:
  • 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


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01343264

Locations
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
Principal Investigator: Joachim Schirren, MD, PhD HSK Wiesbaden
  More Information

No publications provided

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

Keywords provided by HSK Wiesbaden:
Radical Pleurectomy
Pleurectomy/decortication
Cisplatin
Pemetrexed
Radiation

Additional relevant MeSH terms:
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Pemetrexed
Antineoplastic Agents
 Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on May 16, 2013