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
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Published in |
Trials, November 2016
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DOI | 10.1186/s13063-016-1679-4 |
Pubmed ID | |
Authors |
Sebastian Zschaeck, Monique Simon, Steffen Löck, Esther G. C. Troost, Kristin Stützer, Patrick Wohlfahrt, Steffen Appold, Sebastian Makocki, Rebecca Bütof, Christian Richter, Michael Baumann, Mechthild Krause |
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. |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
Unknown | 86 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Researcher | 11 | 13% |
Student > Ph. D. Student | 9 | 10% |
Other | 8 | 9% |
Student > Master | 8 | 9% |
Student > Bachelor | 5 | 6% |
Other | 15 | 17% |
Unknown | 30 | 35% |
Readers by discipline | Count | As % |
---|---|---|
Medicine and Dentistry | 21 | 24% |
Nursing and Health Professions | 10 | 12% |
Physics and Astronomy | 6 | 7% |
Unspecified | 3 | 3% |
Chemical Engineering | 2 | 2% |
Other | 9 | 10% |
Unknown | 35 | 41% |