Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00013150

Trial Description

start of 1:1-Block title

Title

Retrospective, monocentric clinical study to evaluate the impact of induction therapy in patients with IIIA N2 lung cancer following surgical resection

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

[---]*

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Patients in stage IIIA N2 NSCLC that received induction therapy prior to surgical resection are included in this study. Patients are stratified by low and high lymph node ratio (percentage of tumorpositive lymph nodes in the resected lymph nodes). Furthermore mediastinal downstaging and progression free survival is analysed.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00013150
  •   2017/10/23
  •   [---]*
  •   yes
  •   Approved
  •   127/17, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   C34 -  Malignant neoplasm of bronchus and lung
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Patients with histologic proven Stage IIIA N2 NSCLC. In case of proven mediastinal lymph node involvement application of two cycles platinum-based chemotherapy as induction followed by surgical resection if no progress in Re-Staging CT. Analysation of surgical specimen regarding mediastinal lymph node involvement. Clinical follow up
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Overall survival

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

diesease free survival

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2017/04/20
  •   100
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   90   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Stage IIIA N2 NSCLC
written informed consent
resectable tumor
Induction therapy
resection between 01.01.2009 and 31.12.2016

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

no written informed consent
irresectable tumor

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Universitätsklinikum Freiburg
    • Mr.  Dr.  Benedikt  Haager 
    • Hugstetter Strasse 55
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universitätsklinikum Freiburg
    • Mr.  Dr.  Benedikt  Haager 
    • Hugstetter Strasse 55
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Klinik für ThoraxchirurgieUniklinik Freiburg
    • Mr.  Prof. Dr.  Bernward  Passlick 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2017/09/19
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.