title: Ion therapy within the trimodal management of superior sulcus tumors: the INKA trial.
abstract: BACKGROUND
  The standard trimodal treatment concept in locally advanced and non-metastasized non-small-cell superior sulcus tumors consists of a preoperative chemoradiation followed by surgical resection. High linear energy transfer (LET) radiation as, for example, C12 heavy-ion beam therapy theoretically offers biological advantages compared to high energy x-ray therapy as, for example, higher biological efficiency.
  
  
  METHODS
  In the present prospective, single-armed, open pilot study performed at the Heidelberg Ion-Beam Therapy Center (HIT) in Heidelberg, the radiation treatment within the standard trimodal concept will be exchanged against C12 heavy-ion beam treatment and apply 39GyE in 13 single fractions in combination with a chemotherapy consisting of cisplatin and vinorelbine (local standard). The primary endpoint is feasibility and safety measured by the incidence of NCI-CTCAE grade 3/4 toxicity and/or discontinuation due to any reason. Secondary endpoint is the degree of regression in the histological specimen. The main inclusion criteria are histologically confirmed non-small-cell superior sulcus tumor, nodal disease stage ≤ N2, Karnofsky performance score ≥70%, patient age between 18 and 75 years as well as written informed consent. The main exclusion criteria include medical contraindications against elements of the trimodal treatment concept, PET confirmed nodal disease stage N3, stage IV disease, prior thoracic irradiation and decompensated diseases of the lung, cardio-vascular system, metabolism, hematopoietic and coagulation system and renal function. Furthermore, patients with implanted active medical devices without certification for ion-beam therapy are not allowed to take part in the study.
  
  
  BACKGROUND
  DRKS00006323 ( www.drks.de ).
authors.affiliation: Department of Radiation Oncology, University Hospital of Heidelberg, Heidelberg, Germany. henrik.hauswald@med.uni-heidelberg.de.|Heidelberg Institute of Radiation Oncology (HIRO), Heidelberg, Germany. henrik.hauswald@med.uni-heidelberg.de.
authors.forename: Henrik
authors.initials: H
authors.lastname: Hauswald
authors.affiliation: Department of Radiation Oncology, University Hospital of Heidelberg, Heidelberg, Germany. stefan.rieken@med.uni-heidelberg.de.|Heidelberg Institute of Radiation Oncology (HIRO), Heidelberg, Germany. stefan.rieken@med.uni-heidelberg.de.
authors.forename: Stefan
authors.initials: S
authors.lastname: Rieken
authors.affiliation: Department of Thoracic Surgery, Thoraxklinik, University Hospital of Heidelberg, Heidelberg, Germany. hendrik.dienemann@med.uni-heidelberg.de.
authors.forename: Hendrik C
authors.initials: HC
authors.lastname: Dienemann
authors.affiliation: Department of Thoracic Oncology/Internal Medicine, Thoraxklinik, Translational Lung Research Center Heidelberg (TLRC-H), Member of the German Center for Lung Research (DZL), University Hospital of Heidelberg, Heidelberg, Germany. michael.thomas@med.uni-heidelberg.de.
authors.forename: Michael
authors.initials: M
authors.lastname: Thomas
authors.affiliation: Institute for Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany. Meinhard.Kieser@imbi.uni-heidelberg.de.
authors.forename: Meinhard
authors.initials: M
authors.lastname: Kieser
authors.affiliation: Department of Radiation Oncology, University Hospital of Heidelberg, Heidelberg, Germany. Juergen.Debus@med.uni-heidelberg.de.|Heidelberg Institute of Radiation Oncology (HIRO), Heidelberg, Germany. Juergen.Debus@med.uni-heidelberg.de.
authors.forename: Jürgen
authors.initials: J
authors.lastname: Debus
authors.affiliation: Department of Radiation Oncology, University Hospital of Heidelberg, Heidelberg, Germany. Klaus.Herfarth@med.uni-heidelberg.de.|Heidelberg Institute of Radiation Oncology (HIRO), Heidelberg, Germany. Klaus.Herfarth@med.uni-heidelberg.de.
authors.forename: Klaus
authors.initials: K
authors.lastname: Herfarth
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002250:Carbon Radioisotopes / Q000627:therapeutic use; D004307:Dose-Response Relationship, Radiation; D005260:Female; D063193:Heavy Ion Radiotherapy / Q000009:adverse effects / Q000379:methods*; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging
chemical_list: D002250:Carbon Radioisotopes