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.
| Identifer | oai:union.ndltd.org:DRESDEN/oai:qucosa.de:bsz:14-qucosa-219714 |
| Date | 17 March 2017 |
| Creators | 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 |
| Contributors | BioMed Central, |
| Publisher | Saechsische Landesbibliothek- Staats- und Universitaetsbibliothek Dresden |
| Source Sets | Hochschulschriftenserver (HSSS) der SLUB Dresden |
| Language | English |
| Detected Language | English |
| Type | doc-type:article |
| Format | application/pdf |
| Source | Trials (2016), 17(1), S. 543. ISSN 1468-6694. DOI: 10.1186/s13063-016-1679-4 |
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