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Trimodality Therapy for Malignant Pleural Mesothelioma

H

HSK Wiesbaden

Status

Unknown

Conditions

Malignant Pleural Mesothelioma

Study type

Observational

Funder types

Other

Identifiers

NCT01343264
RP2002-01

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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