Cargando…
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
BACKGROUND: 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...
Autores principales: | , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2016
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5111266/ https://www.ncbi.nlm.nih.gov/pubmed/27846903 http://dx.doi.org/10.1186/s13063-016-1679-4 |
_version_ | 1782467835631501312 |
---|---|
author | Zschaeck, Sebastian Simon, Monique Löck, Steffen Troost, Esther G. C. Stützer, Kristin Wohlfahrt, Patrick Appold, Steffen Makocki, Sebastian Bütof, Rebecca Richter, Christian Baumann, Michael Krause, Mechthild |
author_facet | Zschaeck, Sebastian Simon, Monique Löck, Steffen Troost, Esther G. C. Stützer, Kristin Wohlfahrt, Patrick Appold, Steffen Makocki, Sebastian Bütof, Rebecca Richter, Christian Baumann, Michael Krause, Mechthild |
author_sort | Zschaeck, Sebastian |
collection | PubMed |
description | BACKGROUND: 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. METHODS/DESIGN: 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. DISCUSSION: 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. TRIAL REGISTRATION: Registered at ClinicalTrials.gov with Identifier NCT02731001 on 1 April 2016. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-016-1679-4) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-5111266 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-51112662016-11-25 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 Zschaeck, Sebastian Simon, Monique Löck, Steffen Troost, Esther G. C. Stützer, Kristin Wohlfahrt, Patrick Appold, Steffen Makocki, Sebastian Bütof, Rebecca Richter, Christian Baumann, Michael Krause, Mechthild Trials Study Protocol BACKGROUND: 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. METHODS/DESIGN: 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. DISCUSSION: 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. TRIAL REGISTRATION: Registered at ClinicalTrials.gov with Identifier NCT02731001 on 1 April 2016. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-016-1679-4) contains supplementary material, which is available to authorized users. BioMed Central 2016-11-15 /pmc/articles/PMC5111266/ /pubmed/27846903 http://dx.doi.org/10.1186/s13063-016-1679-4 Text en © The Author(s). 2016 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Study Protocol Zschaeck, Sebastian Simon, Monique Löck, Steffen Troost, Esther G. C. Stützer, Kristin Wohlfahrt, Patrick Appold, Steffen Makocki, Sebastian Bütof, Rebecca Richter, Christian Baumann, Michael Krause, Mechthild 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 |
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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5111266/ https://www.ncbi.nlm.nih.gov/pubmed/27846903 http://dx.doi.org/10.1186/s13063-016-1679-4 |
work_keys_str_mv | AT zschaecksebastian prontoxprotontherapytoreduceacutenormaltissuetoxicityinlocallyadvancednonsmallcelllungcarcinomasnsclcstudyprotocolforarandomisedcontrolledtrial AT simonmonique prontoxprotontherapytoreduceacutenormaltissuetoxicityinlocallyadvancednonsmallcelllungcarcinomasnsclcstudyprotocolforarandomisedcontrolledtrial AT locksteffen prontoxprotontherapytoreduceacutenormaltissuetoxicityinlocallyadvancednonsmallcelllungcarcinomasnsclcstudyprotocolforarandomisedcontrolledtrial AT troostesthergc prontoxprotontherapytoreduceacutenormaltissuetoxicityinlocallyadvancednonsmallcelllungcarcinomasnsclcstudyprotocolforarandomisedcontrolledtrial AT stutzerkristin prontoxprotontherapytoreduceacutenormaltissuetoxicityinlocallyadvancednonsmallcelllungcarcinomasnsclcstudyprotocolforarandomisedcontrolledtrial AT wohlfahrtpatrick prontoxprotontherapytoreduceacutenormaltissuetoxicityinlocallyadvancednonsmallcelllungcarcinomasnsclcstudyprotocolforarandomisedcontrolledtrial AT appoldsteffen prontoxprotontherapytoreduceacutenormaltissuetoxicityinlocallyadvancednonsmallcelllungcarcinomasnsclcstudyprotocolforarandomisedcontrolledtrial AT makockisebastian prontoxprotontherapytoreduceacutenormaltissuetoxicityinlocallyadvancednonsmallcelllungcarcinomasnsclcstudyprotocolforarandomisedcontrolledtrial AT butofrebecca prontoxprotontherapytoreduceacutenormaltissuetoxicityinlocallyadvancednonsmallcelllungcarcinomasnsclcstudyprotocolforarandomisedcontrolledtrial AT richterchristian prontoxprotontherapytoreduceacutenormaltissuetoxicityinlocallyadvancednonsmallcelllungcarcinomasnsclcstudyprotocolforarandomisedcontrolledtrial AT baumannmichael prontoxprotontherapytoreduceacutenormaltissuetoxicityinlocallyadvancednonsmallcelllungcarcinomasnsclcstudyprotocolforarandomisedcontrolledtrial AT krausemechthild prontoxprotontherapytoreduceacutenormaltissuetoxicityinlocallyadvancednonsmallcelllungcarcinomasnsclcstudyprotocolforarandomisedcontrolledtrial |