Trimodality Therapy for Malignant Pleural Mesothelioma

NCT01343264 | Unknown

• 1 other identifier: RP2002-01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Malignant Pleural Mesothelioma

Keywords

Radical Pleurectomy; Pleurectomy/decortication; Cisplatin; Pemetrexed; Radiation

Outcome Measures

Primary Outcomes (1)

• To determine the overall 5-year survival rate.

  5-years

Secondary Outcomes (3)

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  3 months

• Number of Participants with treatment related deaths as a Measure of Safety and Tolerability

  3 months

• Recurrence

  5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with malignant pleural mesothelioma prsentint at the Deparment of Thoracic Surgery, HSK Wiesbaden

You may qualify if:

• 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

You may not qualify if:

• Patients with unresectable disease
• Patients with an active infection that require systemic treatments
• Patients with a concurrent active malignancy.
• Patients with serious medical illness.

Sponsors & Collaborators

• HSK Wiesbaden: lead

Study Sites (1)

Dr. Horst Schmidt Klinik, Department of Thoracic Surgery

Wiesbaden, Germany

RECRUITING

MeSH Terms

Conditions

Mesothelioma, Malignant

Condition Hierarchy (Ancestors)

Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Joachim Schirren, MD, PhD

  HSK Wiesbaden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 5, 2011
• First Posted: April 28, 2011
• Study Start: November 1, 2002
• Primary Completion: December 1, 2012
• Last Updated: April 28, 2011

Record last verified: 2011-04

Locations

DE (1)