Trimodality Therapy for Malignant Pleural Mesothelioma

• ClinicalTrials.gov Identifier: NCT01343264
• Recruitment Status: Unknown
• First Posted: April 28, 2011
• Last Update Posted: April 28, 2011
• Sponsor: HSK Wiesbaden
• Information provided by: HSK Wiesbaden

Tracking Information

• First Submitted Date: April 5, 2011
• First Posted Date: April 28, 2011
• Last Update Posted Date: April 28, 2011
• Study Start Date: November 2002
• Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 26, 2011): To determine the overall 5-year survival rate. [ Time Frame: 5-years ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: April 26, 2011)

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 3 months ]
  Morbidity
• Number of Participants with treatment related deaths as a Measure of Safety and Tolerability [ Time Frame: 3 months ]
  Mortality
• Recurrence [ Time Frame: 5 years ]
  Occurence of tumor recurrence

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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.

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Patients with malignant pleural mesothelioma prsentint at the Deparment of Thoracic Surgery, HSK Wiesbaden
• Condition: Malignant Pleural Mesothelioma
• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: April 26, 2011): 200
• Original Estimated Enrollment: Same as current
• Study Completion Date: Not Provided
• Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT01343264
• Other Study ID Numbers: RP2002-01
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Prof. Dr. Joachim Schirren, HSK Wiesbaden
• Study Sponsor: HSK Wiesbaden
• Collaborators: Not Provided

Investigators

• Principal Investigator: Joachim Schirren, MD, PhD; HSK Wiesbaden

• PRS Account: HSK Wiesbaden
• Verification Date: April 2011