DARS
Research type
Research Study
Full title
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.
IRAS ID
174042
Contact name
Christopher Nutting
Contact email
Sponsor organisation
Royal Marsden NHS Foundation Trust
Duration of Study in the UK
7 years, 1 months, 30 days
Research summary
Radiotherapy or chemoradiotherapy is the treatment of choice for most newly diagnosed patients with cancer of the pharynx. Although this treatment is often curative it may have adverse consequences on quality of life. Almost half of patients report long term problems with swallowing which are largely related to the radiation of the pharyngeal musculature responsible for swallowing.
Dysphagia-optimised intensity modulated radiotherapy (Do-IMRT) is a novel radiation technique which reduces the radiation dose to the pharyngeal muscles known as the Dysphagia at Risk Structures (DARS). The DARS study aims to determine if Do-IMRT improves swallow function compared to use of standard intensity modulated radiotherapy (S-IMRT) in patients with head and neck cancer treated with radical radiotherapy or chemoradiation.
DARS aims to recruit 102 men and women following diagnosis and before administration of optional induction chemotherapy. Patients will receive either S-IMRT or Do-IMRT.
Radiotherapy doses will be the same in both groups, however in Do-IMRT patients the irradiation of the pharyngeal musculature will be reduced by delivering inverse-planned IMRT identifying the pharyngeal muscles as organs at risk. Unless contra-indicated patients will receive concomitant chemotherapy.
Patients will be asked to complete the MD Anderson Dysphagia Inventory (MDADI) and the University of Washington Quality of Life Questionnaire (UW-QOL) at baseline and at 3,6,12,18 and 24 months after treatment.
Swallowing function will be evaluated using a Water Swallowing Test and the
Performance Status Scale for head and neck cancer (PSS-HN). Patients will be followed up for up to 5 years. The primary endpoint is the difference in MDADI score at 12 months post-treatment between treatment groups. Secondary endpoints include other QoL measures, Normalcy of Diet and Place of Eating scores evaluated using PSS-HN, videofluoroscopy (in a sub-set of centres), loco-regional tumour control and overall survival.
Patients will also be asked to consent to the optional donation of diagnostic paraffin embedded tumour tissue.REC name
London - Queen Square Research Ethics Committee
REC reference
15/LO/1464
Date of REC Opinion
23 Sep 2015
REC opinion
Favourable Opinion