A Multi-centre Randomised Phase III Trial Comparing 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
- To compare the efficacy, in terms of overall survival, disease-specific survival,
recurrence, quality of life, and cost-effectiveness, of a PET/CT scan-guided watch and
wait policy with the current practice of planned neck dissection in the management of
advanced (N2 or N3) nodal metastases in patients with primary head and neck squamous
cell carcinoma undergoing chemoradiotherapy.
- To assess the predictive value of PET/CT scanning in detecting persistent or residual
disease in the primary site.
OUTLINE: This is a multicenter study. Patients are stratified according to center,
chemotherapy schedule (concurrent platinum vs concurrent cetuximab vs neoadjuvant and
concurrent platinum vs neoadjuvant docetaxel, platinum, and fluorouracil with concurrent
platinum), T stage (T1-T2 vs T3-T4), and N stage (N2a-N2b vs N2c-N3). Patients are
randomized to 1 of 2 treatment arms.
- Arm I: Patients receive standard concurrent chemoradiotherapy (CRT). Patients undergo
PET/CT scan at 9-13 weeks after completion of CRT. Patients with complete response of
primary site undergo neck dissection within 4 weeks.
- Arm II: Patients undergo neck dissection and then receive standard CRT. Patients
undergo PET/CT scan at 9-13 weeks after completion of CRT.
Patients are assessed periodically for quality-of-life. Tissue and blood samples collected
periodically are stored for future research.
After completion of study treatment, patients are followed monthly for 1 year and then
bimonthly for 1 year.
Allocation: Randomized, Primary Purpose: Diagnostic
Overall survival at 2 years
Hisham Mehanna, MD
Warwick Medical School