- Titel
- 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
- Zitierfähige Url:
- https://nbn-resolving.org/urn:nbn:de:bsz:14-qucosa-219714
- Quellenangabe
- Trials (2016), 17(1), S. 543. ISSN 1468-6694. DOI: 10.1186/s13063-016-1679-4
- Erstveröffentlichung
- 2016
- Abstract (EN)
- 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.
- Andere Ausgabe
- DOI: 10.1186/s13063-016-1679-4
- Link zum Artikel, der zuerst in der Zeitschrift 'Trials' erschienen ist.
Link: http://dx.doi.org/10.1186/s13063-016-1679-4 - Freie Schlagwörter (DE)
- Protonen-Strahlentherapie, Nicht-kleinzelliger Lungenkrebs (NSCLC), lokal fortgeschritten, Toxizität, Randomisierte klinische Studie, Phase-II-Studie, TU Dresden, Publikationsfonds
- Freie Schlagwörter (EN)
- Proton radiotherapy, Non-small-cell lung cancer (NSCLC), Locally advanced, Toxicity Randomised clinical trial, Phase II trial, TU Dresden, Publishing Fund
- Klassifikation (DDC)
- 610
- Klassifikation (RVK)
- XA 10000
- Verlag
- BioMed Central, London
- URN Qucosa
- urn:nbn:de:bsz:14-qucosa-219714
- Veröffentlichungsdatum Qucosa
- 17.03.2017
- Dokumenttyp
- Artikel
- Sprache des Dokumentes
- Englisch
- Lizenz / Rechtehinweis
CC BY 4.0