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

Research output: Contribution to journalResearch articleContributedpeer-review

Contributors

Abstract

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.

Details

Original languageEnglish
Article number543
JournalTrials
Volume17
Issue number1
Publication statusPublished - 15 Nov 2016
Peer-reviewedYes

External IDs

Scopus 84996486041
researchoutputwizard legacy.publication#73757
PubMed 27846903
PubMedCentral PMC5111266
ORCID /0000-0002-7017-3738/work/142253905
ORCID /0000-0003-4261-4214/work/146644849

Keywords

Sustainable Development Goals

Keywords

  • Carcinoma, Non-Small-Cell Lung/mortality, Clinical Protocols, Humans, Lung Neoplasms/mortality, Prospective Studies, Proton Therapy/adverse effects