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.
Disease site: Head and neck cancer
Treatment modality: Radiotherapy
Status: In follow-up
DARS is a parallel group, phase III, multicentre, randomised-controlled radiotherapy trial to determine if dysphagia optimised intensity modulated radiotherapy (Do-IMRT) compared to standard IMRT (S-IMRT) improves post radiotherapy swallowing difficulties in patients with head and neck cancer.
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 muscles will be reduced by delivering inverse planned IMRT identifying these as organs at risk.
Unless contraindicated, patients will receive concomitant chemotherapy. Participants will be followed up after radiotherapy treatment at regular intervals for 24 months, and then annually for up to 5 years.
Chief Investigator: Professor Christopher Nutting, The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research
ICR-CTSU Scientific Lead: Dr Emma Hall
Trial management contact: [email protected]
Sponsor: The Royal Marsden NHS Foundation Trust
Funding: Cancer Research UK (CRUK/14/014)
Further information including recruitment progress is available from the following link:
UK Clinical Trials Gateway
Patient friendly information is available from the following link:
Cancer Research UK
Publications and presentations
Petkar I, Rooney K, Roe JWG, Patterson JM, Bernstein D, Tyler JM, Emson MA, Morden JP, Mertens K, Miles E, Beasley M, Roques T, Bhide SA, Newbold KL, Harrington KJ, Hall E, Nutting CM. 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. BMC Cancer 2016 16:770.
Nutting C, Rooney K, Foran B, Pettit L, Beasley M, Finneran L, Roe JW ,Tyler JE, Roques T, Cook A, Petkar I, Bhide SA, Srinivasan D, Boon C, De Winton E, Frogley R, Mertens K, Emson E, Hall E, on behalf of the DARS investigators. Results of a randomised phase III study of dysphagia-optimised intensity modulated radiotherapy (Do-IMRT) versus standard IMRT (S-IMRT) in head and neck cancer. Presented at ASCO 2020 Virtual Scientific Progamme, oral abstract sesson, head and neck cancer, abstract 6508. DOI 10.1200/JCO.2020.38.15_suppl.6508.
Tyler J, Bernstein D, Rooney K, Nutting C. Development of dysphagia optimised IMRT for head and neck cancer treatment in the DARS trial. ESTRO 35 2016, Turin, Italy.