Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Trimodality Therapy for Malignant Pleural Mesothelioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01343264
Recruitment Status : Unknown
Verified April 2011 by HSK Wiesbaden.
Recruitment status was:  Recruiting
First Posted : April 28, 2011
Last Update Posted : April 28, 2011
Sponsor:
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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