For further information please contact: Joy K Rahman

1. PET-NECK: A multi-centre randomised phase III trial comparing a PET-CT guided watch & wait policy versus planned neck dissection for the management of locally advanced (N2/N3) nodal metastases in patients with head & neck squamous cancer Objectives • PET NECK: Current treatment for patients with locally advanced head and neck squamous cell carcinoma is neck dissection before or after chemo-radiotherapy. This often results in high morbidity and mortality and alternative and better management is needed. PET-NECK is a phase III randomised controlled trial (560 patients) which is comparing PET-CT guided watch and wait policy versus planned neck dissection for the management of locally advanced head and neck cancer, in terms of: • Efficacy (overall survival, disease-specific survival, local control) • Cost-effectiveness (Health Resource use and Quality of Life) • Safety (complications) • For further information please contact: • Joy K Rahman • Clinical Trials Co-ordinator Warwick Clinical Trials Unit • Division of Health Sciences • Warwick Medical School • The University of Warwick • Coventry • CV4 7AL : +44 (0)2476 150 478 : +44 (0)2476 150 586 : J.K.Rahman@warwick.ac.uk www.warwick.ac.uk/wms Chief Investigator: Professor Hisham Mehanna University Hospitals Coventry & Warwickshire • Accrual duration: 5 years. • Target: 560 patients. • First patient randomised: October 2007. • Patients recruited: 479 as of 21/03/2012. • Planned close: September 2012. • Sites open to recruitment: 53. • Sites in set up: 4. • New sites: No longer open to new sites. • Local Sites Open: UHCW, Heartlands, New Cross Wolverhampton, Manor Hospital Walsall, QE Birmingham, Russells Hall. Schema HEAD & NECK SCC CANCER DIAGNOSIS • KEY ELIGIBILITY CRITERIA • Histological diagnosis of oropharyngeal, laryngeal, oral, hypopharyngeal or occult HN SCC • Clinical and CT/MRI evidence of N2 or N3 nodal metastases • MDT decision for curative concurrent CRT to primary and neck • Written consent and aged over 18 SURVEILLANCE ARM (280 Pts) Standard concomitant CRT. NECK DISSECTION ARM (280 Pts) Standard concomitant CRT with neck dissection (i.e. ND within 4 weeks of randomisation or 4 - 8 weeks after completion of CRT). PET-CT & assessment 13 weeks after CRT completion. (Neck dissection only if neck nodes are positive/equivocal). CT & assessment after completion of CRT. Portfolio Trial Number: 6082