Trial document




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  DRKS00011342

Trial Description

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Title

Multicentric retrospective prognostic evaluation of tumor volumes and their alteration in the curative-intended radiotherapy of the locally advanced NSCLC

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Trial Acronym

[---]*

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The aim of the study is to compare the tumor volume before definitive radiochemotherapy with the tumor volume after treatment in patients with locally advanced NSCLC.

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Brief Summary in Scientific Language

The aim of the study is to examine the association of tumor volume before definite radiochemotherapy and of tumor volume changes during definite radiochemotherapy with overall survival in patients with locally advanced NSCLC (non-small cell bronchial carcinoma).

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Organizational Data

  •   DRKS00011342
  •   2016/11/24
  •   [---]*
  •   yes
  •   Approved
  •   2016-122, Ethikkommission der Medizinischen Fakultät der Martin-Luther-Universität Halle Wittenberg
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Secondary IDs

  •   2017-1  (ARO-Studiennummer (Arbeitsgemeinschaft Radiologische Onkologie ))
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Health Condition or Problem studied

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

  •   CT-based (if available PET- or PET-CT-based) detection of macroscopic tumor volume (GTV1) prior to irradiation (basal GTV) as well as tumor volume changes during radiotherapy (volume increase or decrease of the GTV2 determined in boost planning CT at approximately 40-50 Gy with respect to basal GTV1).

    Correlation of absolute GTV1 and GTV2 as well as GTV changes during radiotherapy (ΔGTV1-2) with sociodemographic clinical patient data as well as the primary endpoints overall survival, progression-free survival and therapy response / tumor control.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   No
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Primary Outcome

Gross tumor volume (GTV basal, before radiotherapy)

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Secondary Outcome

Overall Survival

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Countries of Recruitment

  •   Germany
  •   Switzerland
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Locations of Recruitment

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

  •   Actual
  •   2017/04/01
  •   700
  •   Multicenter trial
  •   International
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Inclusion Criteria

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

• histologically confirmed NSCLC (Adeno / PLECA) stage UICC III A or B
• Age> = 18 years
• complete curative-intended radiotherapy (± chemotherapy), normofraction (achieved total dose ≥60 Gy) or hypofraction (≥50 Gy)

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Exclusion Criteria

•Stereotactic radiotherapy
•Second malignancy <5 years before diagnosis of NSCLC
•Pleural effusion, extensive atelectasis
•Neoadjuvant chemotherapy before RT

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Addresses

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    • Klinik für Strahlentherapie und Radioonkologie Halle
    • Mr.  Dr.  Christian  Ostheimer 
    • Ernst-Grube-Straße 40
    • 06120  Halle (Saale)
    • Germany
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    • Klinik für Strahlentherapie und Radioonkologie Jena
    • Mr.  Dr.  Matthias  Mäurer 
    • Bachstr. 18
    • 07743  Jena
    • Germany
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    • Klinik für Strahlentherapie und Radioonkologie Halle
    • Mr.  Dr.  Christian  Ostheimer 
    • Ernst-Grube-Straße 40
    • 06120  Halle (Saale)
    • Germany
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    • Klinik für Strahlentherapie und Radioonkologie Halle
    • Mr.  Dr.  Christian  Ostheimer 
    • Ernst-Grube-Straße 40
    • 06120  Halle (Saale)
    • Germany
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Sources of Monetary or Material Support

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    • Arbeitsgemeinschaft Radiologische Onkologie (ARO)
    • Mr.  Prof.  Frederik  Wenz 
    • Kuno-Fischer-Straße 8
    • 14057   Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2018/07/01
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.