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@ARTICLE{Safi:132653,
      author       = {S. Safi and P. Beckhove$^*$ and A. Warth and A. Benner$^*$
                      and F. Roeder$^*$ and S. Rieken and J. Debus$^*$ and H.
                      Dienemann and H. Hoffmann and P. Huber$^*$},
      title        = {{A} randomized phase {II} study of radiation induced immune
                      boost in operable non-small cell lung cancer ({R}ad{I}mmune
                      trial).},
      journal      = {BMC cancer},
      volume       = {15},
      number       = {1},
      issn         = {1471-2407},
      address      = {London},
      publisher    = {BioMed Central},
      reportid     = {DKFZ-2018-00313},
      pages        = {988},
      year         = {2015},
      abstract     = {Lung cancer is the leading cause of cancer deaths
                      worldwide. Surgery, radiotherapy at conventional and high
                      dose and chemotherapy are the mainstay for lung cancer
                      treatment. Insufficient migration and activation of tumour
                      specific effector T cells seem to be important reasons for
                      inadequate host anti-tumour immune response. Ionizing
                      radiation can induce a variety of immune responses. The goal
                      of this randomized trial is to assess if a preoperative
                      single fraction low dose radiation is able to improve
                      anti-tumour immune response in operable early stage lung
                      cancer.This trial has been designed as an
                      investigator-initiated, prospective, randomized, 2-armed
                      phase II trial. Patients who are candidates for elective
                      resection of early stage non-small cell lung cancer will be
                      randomized into 2 arms. A total of 36 patients will be
                      enrolled. The patients receive either 2 Gy or no radiation
                      prescribed to their primary tumour. Radiation will be
                      delivered by external beam radiotherapy using 3D
                      radiotherapy or intensity-modulated radiation technique
                      (IMRT) 7 days prior to surgical resection. The primary
                      objective is to compare CD8+ T cell counts detected by
                      immunohistochemistry in resected tumours following
                      preoperative radiotherapy versus no radiotherapy. Secondary
                      objectives include the association between CD8+ T cell
                      counts and progression free survival, the correlation of
                      CD8+ T cell counts quantified by immunohistochemistry and
                      flow cytometry, local tumour control and recurrence
                      patterns, survival, radiogenic treatment toxicity and
                      postoperative morbidity and mortality. Further, frequencies
                      of tumour reactive T cells in blood and bone marrow as well
                      as whole blood cell transcriptomics and plasma-proteomics
                      will be correlated with clinical outcome.This unique
                      intervention combining preoperative low dose radiation and
                      surgical removal of early stage non-small cell lung cancer
                      is designed to address the problem of inadequate host
                      anti-tumour immune response. If successful, this study may
                      affect the role of radiotherapy in lung cancer
                      treatment.NCT02319408;December 29, 2014.},
      cin          = {D015 / C060 / E055 / E050},
      ddc          = {610},
      cid          = {I:(DE-He78)D015-20160331 / I:(DE-He78)C060-20160331 /
                      I:(DE-He78)E055-20160331 / I:(DE-He78)E050-20160331},
      pnm          = {315 - Imaging and radiooncology (POF3-315)},
      pid          = {G:(DE-HGF)POF3-315},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:26686362},
      pmc          = {pmc:PMC4684916},
      doi          = {10.1186/s12885-015-2006-2},
      url          = {https://inrepo02.dkfz.de/record/132653},
}