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Trial Title:
Trimodality Therapy for Malignant Pleural Mesothelioma
NCT ID:
NCT01343264
Condition:
Malignant Pleural Mesothelioma
Conditions: Official terms:
Mesothelioma
Mesothelioma, Malignant
Conditions: Keywords:
Radical Pleurectomy
Pleurectomy/decortication
Cisplatin
Pemetrexed
Radiation
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
Patients with malignant pleural mesothelioma prsentint at the Deparment of Thoracic
Surgery, HSK Wiesbaden
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Dr. Horst Schmidt Klinik, Department of Thoracic Surgery
Address:
City:
Wiesbaden
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Joachim Schirren, MD, PhD
Phone:
+49 611 433132
Email:
joachim.schirren@hsk-wiesbaden.de
Investigator:
Last name:
Joachim Schirren, MD, PhD
Email:
Principal Investigator
Investigator:
Last name:
Servet Bölükbas, MD, PhD
Email:
Sub-Investigator
Start date:
November 2002
Lead sponsor:
Agency:
HSK Wiesbaden
Agency class:
Other
Source:
HSK Wiesbaden
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01343264
