Positron Emission Tomography-Computerised Tomography scans (PET-CT) guided watch and wait policy versus planned neck dissection for the management of locally advanced (N2/N3) nodal metastases in patients with head and neck squamous cancer

The study has gained the support of the NCRI Head & Neck Clinical Studies Group (main HNC research committee in UK), the principal investigator's local Arden Network Site Specific Group and most (20/34) of the major head and neck centres in the UK. DESIGN: PET-NECK is a pragmatic randomised controlled multi-centre phase III trial. Please see consort diagram (figure 1, p16) and schedule of assessments (table 2) in the proposal. All patients will receive chemoradiotherapy. Eligible patients are randomised to one of two arms: Experimental arm: CRT followed by PET-CT done at 3 months (range 9-13 weeks) after CRT completion: if neck -ve on PET-CT scan ----- watch and wait if neck +ve on PET-CT scan ---- neck dissection within 2 - 4 weeks Control arm: CRT + planned neck dissection All patients are assessed for response to CRT at 9-13 weeks after completion of CRT with the following below: 1. CT scan of neck and primary, 2. examination under anaesthetic (EUA) +/- biopsy; i.e. current 'gold standard' staging If residual disease is detected at PRIMARY site ( i.e. does not show complete response after CRT), patient will be immediately withdrawn from trial to be considered by their treating team for salvage surgery. The incidence of this is expected to be equal in both arms due to randomisation. SETTING: Department of Health (DoH) designated head and neck cancer centres (tertiary referral centres) of which we have support to date from 20 out of 34 centres (covering a NHC catchment population of 34 million). TARGET POPULATION: patients with squamous cancer of head and neck (T1-4) with advanced (N2 or N3) neck nodal metastasis, being treated with radical (curative) CRT. HEALTH TECHNOLOGIES BEING ASSESSED: a. Non-inferiority of PET-CT determined watch and wait (surveillance) policy in patients exhibiting complete response to CRT compared to the current practice of performing a planned neck dissection (before or after CRT) on all patients (whether or not there is evidence of residual disease). b. Accuracy of PET-CT compared to current gold standards (CT scan and EUA) in detecting residual disease at both primary site and neck after CRT. MEASUREMENT OF COSTS AND OUTCOMES: Primary endpoint: Overall survival with death from any cause defined as an event and survival times calculated as described in the proposal. Follow-up will be carried out on a monthly basis in the first year and two monthly in the second year, and copies of all death certificates requested from the Office of National Statistics (ONS) to confirm the date of death.