Trial document




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  DRKS00004897

Trial Description

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Title

Randomized multicenter trial to compare standard lobectomy versus anatomical segmentectomy each plus radical lymphadenectomy in patients with Non-Small Cell Lung Cancer (NSCLC) pT1a pN0 cM0, Stage IA

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Trial Acronym

SevLoT1a

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URL of the Trial

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Brief Summary in Lay Language

Overall survival, lifequality and lungfunction in patients with NSCLC (<2cm) without lymphnode-involvement and with 2 cm tumorfree resection margins will be compared in pts. undergoing segmentectomy and lobectomy to establish segmentectomy as new operative standard. Data of cardial or pulmonary compriomised pts. suggest that better life quality with comparable outcome of survival can be expected.

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Brief Summary in Scientific Language

Prospective, randomized, multicenter trial in thoracic surgery to proof if segmentectomy should be establish as new standard procedure in early NSCLS, Stage IA

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00004897
  •   2013/09/02
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  •   yes
  •   Approved
  •   13-5520-BO, Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
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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

  •   lobectomy and lymphadenectomy
  •   segmentectomy and lymphadenectomy
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

5 years follow-up: onlogical screening: Overall survival, quality of life

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Secondary Outcome

FU: diseasefree survial, lungfunction, postop. complications, 30 days-mortality

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Countries of Recruitment

  •   Germany
  •   Switzerland
  •   Austria
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/10/17
  •   560
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

- NSCLC smaller 2 cm diameter
- no lymphnode metastasis
- tumorfree resections margins of min. 2 cm
- lungfunction suffient for lobectomy
- able to give informed consent

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Exclusion Criteria

- any lymphnode-involvement, tumorsize over 2 cm diameter
- known second malignancy, history of radiation or chemotherapy within the last 5 years
- psychatric or other disorders compromising to give writen informed consent or follow-up

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Addresses

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    • Uniklinikum Essen
    • Mr.  kaufmännischer Direktor  Dr. Nicolai  Kranz 
    • Hufelandstraße 55
    • 45122  Essen
    • Germany
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    • Ruhrlandklinik - Das Lungenzentrum Klinik für Thoraxchirurgie und thorakale Endoskopie
    • Mr.  Prof. Dr.  Georgios  Stamatis 
    • Tüschener Weg 40
    • 45239  Essen
    • Germany
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    • Ruhrlandklinik - Das Lungenzentrum, Klinik für Thoraxchirurgie und thorakale Endoskopie
    • Mr.  Dr. med., MPH  Matthias  Altmayer 
    • Tüschener Weg 40
    • 45239  Essen
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53174  Bonn
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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