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Trimodality Therapy for Malignant Pleural Mesothelioma

NCT ID: NCT01343264

Last Updated: 2011-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Malignant Pleural Mesothelioma

Keywords

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Radical Pleurectomy Pleurectomy/decortication Cisplatin Pemetrexed Radiation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HSK Wiesbaden

OTHER

Sponsor Role lead

Responsible Party

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HSK Wiesbaden

Principal Investigators

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Joachim Schirren, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

HSK Wiesbaden

Locations

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Dr. Horst Schmidt Klinik, Department of Thoracic Surgery

Wiesbaden, , Germany

Site Status RECRUITING

Countries

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Germany

Facility Contacts

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Joachim Schirren, MD, PhD

Role: primary

Other Identifiers

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RP2002-01

Identifier Type: -

Identifier Source: org_study_id