title: PRONTOX - proton therapy to reduce acute normal tissue toxicity in locally advanced non-small-cell lung carcinomas (NSCLC): study protocol for a randomised controlled trial.
abstract: Primary radiochemotherapy with photons is the standard treatment for locally advanced-stage non-small cell lung cancer (NSCLC) patients. Acute radiation-induced side effects such as oesophagitis and radiation pneumonitis limit patients' quality of life, and the latter can be potentially life-threatening. Due to its distinct physical characteristics, proton therapy enables better sparing of normal tissues, which is supposed to translate into a reduction of radiation-induced side effects.
  
  
  
  This is a single-centre, prospective, randomised controlled, phase II clinical trial to compare photon to proton radiotherapy up to 66 Gy (RBE) with concomitant standard chemotherapy in patients with locally advanced-stage NSCLC. Patients will be allocated in a 1:1 ratio to photon or proton therapy, and treatment will be delivered slightly accelerated with six fractions of 2 Gy (RBE) per week.
  
  
  
  The overall aim of the study is to show a decrease of early and intermediate radiation-induced toxicity using proton therapy. For the primary endpoint of the study we postulate a decrease of radiation-induced side effects (oesophagitis and pneumonitis grade II or higher) from 39 to 12%. Secondary endpoints are locoregional and distant failure, overall survival and late side effects.
  
  
  
  Registered at ClinicalTrials.gov with Identifier NCT02731001 on 1 April 2016.
authors.affiliation: Department of Radiation Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, OncoRay - National Center for Radiation Research in Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden and Helmholtz-Zentrum Dresden - Rossendorf, German Cancer Consortium (DKTK) Dresden and German Cancer Research Center (DKFZ), National Center for Tumor Diseases (NCT), Partner Site Dresden, Fetscherstr. 74, Dresden, 01307, Germany. sebastian.zschaeck@uniklinikum-dresden.de.
authors.forename: Sebastian
authors.initials: S
authors.lastname: Zschaeck
authors.affiliation: German Cancer Consortium (DKTK), German Cancer Research Center (DKFZ), Department of Radiation Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, National Center for Tumor Diseases (NCT), Partner Site Dresden, Fetscherstr. 74, Dresden, 01307, Germany.
authors.forename: Monique
authors.initials: M
authors.lastname: Simon
authors.affiliation: OncoRay - National Center for Radiation Research in Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden and Helmholtz-Zentrum Dresden - Rossendorf, National Center for Tumor Diseases (NCT), Partner Site Dresden, Fetscherstr. 74, Dresden, 01307, Germany.
authors.forename: Steffen
authors.initials: S
authors.lastname: Löck
authors.affiliation: Helmholtz-Zentrum Dresden - Rossendorf, Institute of Radiooncology, Department of Radiation Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, OncoRay - National Center for Radiation Research in Oncology, German Cancer Consortium (DKTK), German Cancer Research Center (DKFZ), National Center for Tumor Diseases (NCT), Partner Site Dresden, Bautzner Landstr. 400, Dresden, 01328, Germany.
authors.forename: Esther G C
authors.initials: EG
authors.lastname: Troost
authors.affiliation: OncoRay - National Center for Radiation Research in Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Helmholtz-Zentrum Dresden - Rossendorf, Fetscherstr. 74, PF 41, Dresden, 01307, Germany.
authors.forename: Kristin
authors.initials: K
authors.lastname: Stützer
authors.affiliation: OncoRay - National Center for Radiation Research in Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Helmholtz-Zentrum Dresden - Rossendorf, Fetscherstr. 74, PF 41, Dresden, 01307, Germany.
authors.forename: Patrick
authors.initials: P
authors.lastname: Wohlfahrt
authors.affiliation: Department of Radiation Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, National Center for Tumor Diseases (NCT), Partner Site Dresden, Fetscherstr. 74, Dresden, 01307, Germany.
authors.forename: Steffen
authors.initials: S
authors.lastname: Appold
authors.affiliation: Department of Radiation Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, OncoRay - National Center for Radiation Research in Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden and Helmholtz-Zentrum Dresden - Rossendorf, National Center for Tumor Diseases (NCT), Partner Site Dresden, Fetscherstr. 74, Dresden, 01307, Germany.
authors.forename: Sebastian
authors.initials: S
authors.lastname: Makocki
authors.affiliation: Department of Radiation Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, OncoRay - National Center for Radiation Research in Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden and Helmholtz-Zentrum Dresden - Rossendorf, National Center for Tumor Diseases (NCT), Partner Site Dresden, Fetscherstr. 74, Dresden, 01307, Germany.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Bütof
authors.affiliation: OncoRay - National Center for Radiation Research in Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus and Helmholtz-Zentrum Dresden - Rossendorf, Technische Universität Dresden,German Cancer Consortium (DKTK) Dresden and German Cancer Research Center (DKFZ), Heidelberg, Helmholtz-Zentrum Dresden - Rossendorf, Institute of Radiooncology, Fetscherstr. 74, Dresden, 01307, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Richter
authors.affiliation: Department of Radiation Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, OncoRay - National Center for Radiation Research in Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden and Helmholtz-Zentrum Dresden - Rossendorf, German Cancer Consortium (DKTK) Dresden and German Cancer Research Center (DKFZ) Heidelberg, Helmholtz-Zentrum Dresden - Rossendorf, Institute of Radiooncology, National Center for Tumor Diseases (NCT), Partner Site Dresden, Fetscherstr. 74, Dresden, 01307, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Baumann
authors.affiliation: Department of Radiation Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, OncoRay - National Center for Radiation Research in Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden and Helmholtz-Zentrum Dresden - Rossendorf German Cancer Consortium (DKTK) Dresden, German Cancer Research Center (DKFZ) Heidelberg, Helmholtz-Zentrum Dresden - Rossendorf, National Center for Tumor Diseases (NCT), Partner Site Dresden, Fetscherstr. 74, Dresden, 01307, Germany.
authors.forename: Mechthild
authors.initials: M
authors.lastname: Krause
mesh_terms: D002289:Carcinoma, Non-Small-Cell Lung / Q000401:mortality / Q000532:radiotherapy*; D002985:Clinical Protocols; D006801:Humans; D008175:Lung Neoplasms / Q000401:mortality / Q000532:radiotherapy*; D011446:Prospective Studies; D061766:Proton Therapy / Q000009:adverse effects
keywords: Locally advanced; Non-small-cell lung cancer (NSCLC); Phase II trial; Photon radiotherapy; Proton radiotherapy; Randomised clinical trial; Toxicity