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BMC Cancer
Published in: BMC Cancer 1/2016

Open Access 01-12-2016 | Study protocol

DARS: a phase III randomised multicentre study of dysphagia- optimised intensity- modulated radiotherapy (Do-IMRT) versus standard intensity- modulated radiotherapy (S-IMRT) in head and neck cancer

Authors: Imran Petkar, Keith Rooney, Justin W. G. Roe, Joanne M. Patterson, David Bernstein, Justine M. Tyler, Marie A. Emson, James P. Morden, Kathrin Mertens, Elizabeth Miles, Matthew Beasley, Tom Roques, Shreerang A. Bhide, Kate L. Newbold, Kevin J. Harrington, Emma Hall, Christopher M. Nutting

Published in: BMC Cancer | Issue 1/2016

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Abstract

Background

Persistent dysphagia following primary chemoradiation (CRT) for head and neck cancers can have a devastating impact on patients’ quality of life. Single arm studies have shown that the dosimetric sparing of critical swallowing structures such as the pharyngeal constrictor muscle and supraglottic larynx can translate to better functional outcomes. However, there are no current randomised studies to confirm the benefits of such swallow sparing strategies. The aim of Dysphagia/Aspiration at risk structures (DARS) trial is to determine whether reducing the dose to the pharyngeal constrictors with dysphagia-optimised intensity- modulated radiotherapy (Do-IMRT) will lead to an improvement in long- term swallowing function without having any detrimental impact on disease-specific survival outcomes.

Methods/design

The DARS trial (CRUK/14/014) is a phase III multicentre randomised controlled trial (RCT) for patients undergoing primary (chemo) radiotherapy for T1-4, N0-3, M0 pharyngeal cancers. Patients will be randomised (1:1 ratio) to either standard IMRT (S-IMRT) or Do-IMRT. Radiotherapy doses will be the same in both groups; however in patients allocated to Do-IMRT, irradiation of the pharyngeal musculature will be reduced by delivering IMRT identifying the pharyngeal muscles as organs at risk. The primary endpoint of the trial is the difference in the mean MD Anderson Dysphagia Inventory (MDADI) composite score, a patient-reported outcome, measured at 12 months post radiotherapy. Secondary endpoints include prospective and longitudinal evaluation of swallow outcomes incorporating a range of subjective and objective assessments, quality of life measures, loco-regional control and overall survival. Patients and speech and language therapists (SLTs) will both be blinded to treatment allocation arm to minimise outcome-reporting bias.

Discussion

DARS is the first RCT investigating the effect of swallow sparing strategies on improving long-term swallowing outcomes in pharyngeal cancers. An integral part of the study is the multidimensional approach to swallowing assessment, providing robust data for the standardisation of future swallow outcome measures. A translational sub- study, which may lead to the development of future predictive and prognostic biomarkers, is also planned.

Trial registration

This study is registered with the International Standard Randomised Controlled Trial register, ISRCTN25458988 (04/01/2016)
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Metadata
Title
DARS: a phase III randomised multicentre study of dysphagia- optimised intensity- modulated radiotherapy (Do-IMRT) versus standard intensity- modulated radiotherapy (S-IMRT) in head and neck cancer
Authors
Imran Petkar
Keith Rooney
Justin W. G. Roe
Joanne M. Patterson
David Bernstein
Justine M. Tyler
Marie A. Emson
James P. Morden
Kathrin Mertens
Elizabeth Miles
Matthew Beasley
Tom Roques
Shreerang A. Bhide
Kate L. Newbold
Kevin J. Harrington
Emma Hall
Christopher M. Nutting
Publication date
01-12-2016
Publisher
BioMed Central
Published in
BMC Cancer / Issue 1/2016
Electronic ISSN: 1471-2407
DOI
https://doi.org/10.1186/s12885-016-2813-0

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