Trial document





This trial has been registered retrospectively.
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  DRKS00003864

Trial Description

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Title

Stereotactic ablative radiotherapy (SABR) for small lung tumors: retrospective analysis 2009-2010

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Trial Acronym

SABR

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URL of the Trial

[---]*

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Brief Summary in Lay Language



in this investigation treatment results of patients with small lung tumors, who were treated with stereotactic ablative radiotherapy with moderate dose schedule from 2009 to 2010, were evaluated retrrospectively.


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Brief Summary in Scientific Language

retrospective analysis after Stereotactic ablative radiotherapy (SABR) for small lung tumors: retrospective analysis 2009-2010

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Organizational Data

  •   DRKS00003864
  •   2016/02/18
  •   [---]*
  •   yes
  •   Approved
  •   268/11, 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
  •   C78.0 -  Secondary malignant neoplasm of lung
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Interventions/Observational Groups

  •   SABR was performed with total doses of 35 Gy (5 fractions) or 37.5 Gy (3 fractions) prescribed to the 60% isodose line encompassing the PTV.
    Three-monthly follow-up CT scans were supplemented by FDG-PET/CT if clinically indicated
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Local progression-free survival rates after stereotactic ablative radiotherapy (SABR) for small lung tumors at one year and two years
(CT scans every 3 months or PET/CT respectively)

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Secondary Outcome

overall survival, rate of toxicities

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2011/07/19
  •   39
  •   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

- presence of one or two FDG-PET positive pulmonary nodules </= 5cm diameter suspicious for primary lung cancer or metastasis by CT
- Karnofsky index >/= 60%
- Life expectancy > 6 months
- Age > 18 years (no other age limits)
- Informed consent signed in accordance with institutional protocol

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Exclusion Criteria

- NSCLC: FDG-PET N+ if not ruled out by mediastinoscopy or other tissue sampling
- in metastases: disseminated progressive disease without local control to be reasonably expected by current treatment
- Histologically proven SCLC
- More than two lesions to treat
- Diameter of tumor > 5cm
- Systemic therapy +/- one week of treatment
- psychological/mental status does not allow informed consent and participation in QoL assessments
- Pregnancy

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Addresses

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    • Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
    • Ms.  Prof.  Ursula  Nestle 
    • Robert-Koch-Str. 3
    • 79106  Freiburg
    • Germany
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    • Universtätsklinik Freiburg i. Br. Klinik für Strahlenheilkunde
    • Ms.  Dr  Viola  Duncker-Rohr 
    • Robert-Koch-Str. 3
    • 79106  Freiburg
    • Germany
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    • Universtätsklinik Freiburg i. Br. Klinik für Strahlenheilkunde
    • Ms.  Dr  Viola  Duncker-Rohr 
    • Robert-Koch-Str. 3
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
    • Ms.  Prof.  Ursula  Nestle 
    • Robert-Koch-Str. 3
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2011/12/31
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Trial Publications, Results and other Documents

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