Parotid-sparing intensity modulated versus conventional radiotherapy in head and neck cancer (PARSPORT): a phase 3 multicentre randomised controlled trial
The Lancet Oncology, Early Online Publication, 13 January 2011 Dr Christopher M Nutting FRCR a b , James P Morden MSc b, Kevin J Harrington FRCR a b, Teresa Guerrero Urbano PhD c, Shreerang A Bhide FRCR a, Catharine Clark PhD d, Elizabeth A Miles MPhil e, Aisha B Miah FRCR a, Kate Newbold FRCR a, MaryAnne Tanay MSc a, Fawzi Adab FRCR f, Sarah J Jefferies FRCR g, Christopher Scrase FRCR h, Beng K Yap FRCR i, Roger P A'Hern MSc b, Mark A Sydenham BSc b, Marie Emson BSc b, Emma Hall PhD b, on behalf of the PARSPORT trial management group† Summary Background Xerostomia is the most common late side-effect of radiotherapy to the head and neck. Compared with conventional radiotherapy, intensity-modulated radiotherapy (IMRT) can reduce irradiation of the parotid glands. We assessed the hypothesis that parotid-sparing IMRT reduces the incidence of severe xerostomia. Methods We undertook a randomised controlled trial between Jan 21, 2003, and Dec 7, 2007, that compared conventional radiotherapy (control) with parotid-sparing IMRT. We randomly assigned patients with histologically confirmed pharyngeal squamous-cell carcinoma (T1—4, N0—3, M0) at six UK radiotherapy centres between the two radiotherapy techniques (1:1 ratio). A dose of 60 or 65 Gy was prescribed in 30 daily fractions given Monday to Friday. Treatment was not masked. Randomization was by computer-generated permuted blocks and was stratified by centre and tumor site. Our primary endpoint was the proportion of patients with grade 2 or worse xerostomia at 12 months, as assessed by [...]