Trial document




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  DRKS00012291

Trial Description

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Title

Pulmonary metastasectomy for malignant melanoma – Outcome and survival
a retrospective analysis

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Pulmonary Metastasectomy is a wide spread and established procedure for metastatic disease. The prognosis for metastatic melanoma is poor, however a number of reports show a benefit in terms of DFS and OS in selected patients undergoing surgery with curative intent for metastatic melanoma. This procedure has been performed at our institution since many recent years. A detailed analysis of outcome and disease-free survival has never been done yet. The aim of the study is to analyze patients who undergone pulmonary metastasectomy for malignant melanoma treated at the Department of Thoracic Surgery at the University Medical Center Freiburg concerning disease free survival and overall survival.

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Brief Summary in Scientific Language

Pulmonary Metastasectomy is a wide spread and established procedure for metastatic disease. The prognosis for metastatic melanoma is poor, however a number of reports show a benefit in terms of DFS and OS in selected patients undergoing surgery with curative intent for metastatic melanoma.
This procedure has been performed at our institution since many recent years. A detailed analysis of outcome and disease-free survival has never been done yet.

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Organizational Data

  •   DRKS00012291
  •   2017/10/18
  •   [---]*
  •   yes
  •   Approved
  •   472/17, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   C34 -  Malignant neoplasm of bronchus and lung
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Interventions/Observational Groups

  •   The following data will be collected retrospectively:
    Age, gender, tumor size, primary tumor characteristics, tumor position, complete resection, recurrence, number of metastases, operation date, operation technique, Mortality, overall survival, disease-free survival
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

The primary endpoint is disease free survival and overall survival

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Secondary Outcome

Several subgroups will be investigated with respect to overall survival (one metastasis vs. more than one metastasis; melanoma type).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/10/12
  •   37
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Patients with malignant melanoma who underwent a pulmonary metastasectomy at our institution between 2005-2014 in curative intent.

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Exclusion Criteria

Extrapulmonary disease manifestation, physical condition inadequate for surgery.

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Addresses

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    • UNIVERSITÄTSKLINIKUM FREIBURG Department Chirurgie Klinik für Thoraxchirurgie
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • UNIVERSITÄTSKLINIKUM FREIBURGDepartment ChirurgieKlinik für Thoraxchirurgie
    • Mr.  Pawel  Leskow 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • UNIVERSITÄTSKLINIKUM FREIBURGDepartment ChirurgieKlinik für Thoraxchirurgie
    • Mr.  Pawel  Leskow 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • UNIVERSITÄTSKLINIKUM FREIBURG Department Chirurgie Klinik für Thoraxchirurgie
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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