Trial document





This trial has been registered retrospectively.
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  DRKS00011266

Trial Description

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Title

L-AP-IS: Lung cancer, Ablative high Precision radiotherapy and the Immune System: Evaluation of the immune-modulatory effects of stereotactic body radiation therapy (SBRT) of pulmonary lesions

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Trial Acronym

L-AP-IS

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URL of the Trial

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Brief Summary in Lay Language

High precision radiotherapy (SBRT) leads to cell death of tumor cells, but also to specific immune response against the tumor. Main objective of this trial is to analyse potential changes of certain biomarkers of the immune response in the blood of patients who get tretaed with SBRT for lung cancer or lung metastases.

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Brief Summary in Scientific Language

The main objective of this approach is to prospectively evaluate novel and minimally invasive biomarkers of (tumor specific) immune response to SBRT in NSCLC patients, as well as in patients with solitary or oligometastatic pulmonary metastases.

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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

  •   DRKS00011266
  •   2017/01/10
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  •   yes
  •   Approved
  •   38/16, 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

  •   Blood samples of patients with primary or recurrent NSCLC collected before, during and after SBRT (Stereotactic Body RadioTherapy) will be evaluated for immunespecific, circulating biomarkers.
  •   Blood samples of patients with pulmonary metastases will be evaluated for immune-specific, circulating biomarkers.
  •   Patients with systemic treatment within 3 months before SBRT will be separately analyzed and compared to the patients who received no systemic treatment.
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Characteristics

  •   Interventional
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  •   Other
  •   Open (masking not used)
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  •   Other
  •   Basic research/physiological study
  •   Other
  •   I
  •   N/A
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Primary Outcome

Increase of CTL counts six weeks after SBRT compared to baseline

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Secondary Outcome

- Significant changes in number and phenotype of lymphocytes
- Significant changes in number and phenotype of myeloid cells
- Significant changes in circulating biomarkers of immune response in the plasma
- Association between treatment related data and changes in different biomarkers of immune response
- Association between treatment outcomes and changes in different biomarkers of immune response
- Differences in the above mentioned endpoints between patients with or without prior / simultaneous radiation and /or systemic therapy

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/09/06
  •   75
  •   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

• Primary or recurrent non-metastatic NSCLC or
• Solitary or oligometastasic pulmonary metastasis of otherwise controlled malignant
• Lesions confirmed by either histology or cytology or clear imaging signs of malignant tumors
• Patient scheduled and eligible for SBRT with curative intention
• Whole body FDG-PET scan + WB-CT or CT of chest and upper abdomen
• Written informed consent must be given according to ICH/GCP, and national/local regulations
• Adequate birth control measures during the study treatment period

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Exclusion Criteria

• Other active or significantly bone marrow suppressing malignancy
• WHO performance status < 2
• Prior radiotherapy to chest and/or mediastinum within 3 months before the start of SBRT
• Chemotherapy and/or targeted treatment within 3 months before the start of SBRT
• Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
• Pregnancy

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Addresses

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

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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