PET-NECK: A multi-centre, randomized, phase III, controlled trial (RCT) comparing PETCT guided active surveillance with planned neck dissection (ND) for locally advanced (N2/N3) nodal metastases (LANM) in patients with head and neck squamous cell cancer (HNSCC) treated with primary radical chemoradiotherapy (CRT).

6009 Background: Planned ND after radical CRT for LANM remains controversial. 30% of ND specimens show histological evidence of tumour, albeit tumour viability cannot be confirmed. Consequently, many clinicians still practice planned ND. In mainly retrospective single-institution studies, FDG-PETCT demonstrated high negative predictive values for persistent nodal disease, providing a possible alternative paradigm to ND. This study aimed to determine the efficacy and cost-effectiveness of PETCT guided surveillance, compared to planned ND, in a multicentre randomised setting. Methods: Eligibility: Patients with LANM of oro-, hypo-pharynx, larynx, oral or occult HNSCC receiving CRT and fit for ND. Randomisation (1:1): to planned ND before or after CRT (control), or CRT followed by FDG-PETCT 10-12 weeks post CRT with ND only if PETCT showed incomplete or equivocal response of nodal disease (intervention). Balanced by centre, planned ND timing, CRT schedule, disease site, T / N stage. Primary outcome: Overall ...