Trimodality Therapy for Malignant Pleural Mesothelioma

Malignant Pleural Mesothelioma Clinical Trial

Official title:

Trimodality Therapy for Malignant Pleural Mesothelioma: Radical Pleurectomy, Followed by Adjuvant Chemotherapy With Cisplatin/Pemetrexed and Radiotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01343264
• Other study ID #: RP2002-01
• Status: Recruiting
• Phase: N/A
• First received: April 5, 2011
• Last updated: April 26, 2011
• Start date: November 2002

Study information

• Verified date: April 2011
• Source: HSK Wiesbaden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Malignant Pleural Mesothelioma
• Mesothelioma

Locations

Country	Name	City	State
Germany	Dr. Horst Schmidt Klinik, Department of Thoracic Surgery	Wiesbaden

Sponsors (1)

Lead Sponsor	Collaborator
HSK Wiesbaden

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the overall 5-year survival rate.		5-years	Yes
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability	Morbidity	3 months	Yes
Secondary	Number of Participants with treatment related deaths as a Measure of Safety and Tolerability	Mortality	3 months	Yes
Secondary	Recurrence	Occurence of tumor recurrence	5 years	No