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@ARTICLE{Brgemann:179929,
      author       = {D. Brügemann and B. Lehner and M. Kieser and J. Krisam and
                      A. Hommertgen and C. Jaekel and S. B. Harrabi$^*$ and K.
                      Herfarth$^*$ and G. Mechtesheimer and O. Sedlaczek$^*$ and
                      G. Egerer and A. Geisbüsch and M. Uhl and J. Debus$^*$ and
                      K. Seidensaal},
      title        = {{N}eoadjuvant irradiation of extremity soft tissue sarcoma
                      with ions ({E}xtrem-ion): study protocol for a randomized
                      phase {II} pilot trial.},
      journal      = {BMC cancer},
      volume       = {22},
      number       = {1},
      issn         = {1471-2407},
      address      = {Heidelberg},
      publisher    = {Springer},
      reportid     = {DKFZ-2022-00978},
      pages        = {538},
      year         = {2022},
      abstract     = {The standard of care treatment for soft tissue sarcoma of
                      the extremities is a wide resection in combination with pre-
                      or postoperative radiotherapy with high local control rates,
                      sparing patients the necessity of amputation without
                      compromising on overall survival rates. The currently
                      preferred timing of radiotherapy is under debate. Albeit
                      having higher rates of acute wound complications, late side
                      effects like fibrosis, joint stiffness or edema are less
                      frequent in preoperative compared to postoperative
                      radiotherapy. This can be explained in smaller treatment
                      volumes and a lower dose in the preoperative setting.
                      Particles allow better sparing of surrounding tissues at
                      risk, and carbon ions additionally offer biologic advantages
                      and are preferred in less radiosensitive tumors.
                      Hypofractionation allows for a significantly shorter
                      treatment duration.Extrem-ion is a prospective, randomized,
                      monocentric phase II trial. Patients with resectable or
                      marginally resectable, histologically confirmed soft tissue
                      sarcoma of the extremities will be randomized between
                      neoadjuvant proton or neoadjuvant carbon ion radiotherapy in
                      active scanning beam application technique (39 Gy [relative
                      biological effectiveness, RBE] in 13 fractions [5-6
                      fractions per week] in each arm). The primary objective is
                      the proportion of therapies without wound healing disorder
                      the first 120 days after surgery or discontinuation of
                      treatment for any reason related to the treatment. The
                      secondary endpoints of the study consist of local control,
                      local progression-free survival, disease-free survival,
                      overall survival, and quality of life.The aim of this study
                      is to confirm that hypofractionated, preoperative
                      radiotherapy is safe and feasible. The potential for reduced
                      toxicity by the utilization of particle therapy is the
                      rational of this trial. A subsequent randomized phase III
                      trial will compare the hypofractionated proton and carbon
                      ion irradiation in regards to local
                      control.ClinicalTrials.gov Identifier: NCT04946357 ;
                      Retrospectively registered June 30, 2021.},
      keywords     = {Carbon ion therapy (Other) / Extremity soft tissue sarcoma
                      (Other) / Heavy ion therapy (Other) / Hypofractionation
                      (Other) / Irradiation (Other) / Proton therapy (Other) /
                      Randomized trial (Other)},
      cin          = {E050 / E010 / HD01},
      ddc          = {610},
      cid          = {I:(DE-He78)E050-20160331 / I:(DE-He78)E010-20160331 /
                      I:(DE-He78)HD01-20160331},
      pnm          = {315 - Bildgebung und Radioonkologie (POF4-315)},
      pid          = {G:(DE-HGF)POF4-315},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:35550036},
      pmc          = {pmc:PMC9097299},
      doi          = {10.1186/s12885-022-09560-x},
      url          = {https://inrepo02.dkfz.de/record/179929},
}