DUGi

The role of PET/CT in guiding neck treatment decisions in clinically N0 oropharyngeal squamous cell carcinoma

http://dugi.udg.edu/item/http:@@@@hdl.handle.net@@10256@@28687

BACKGROUND: Oropharyngeal squamous cell carcinoma (OPSCC) is a subset of head and neck squamous cell carcinomas (HNSCC), arising from the mucosal epithelium of the oropharynx. Historically associated with tobacco and alcohol use, the epidemiology of OPSCC has shifted in recent decades due to the increasing role of human papillomavirus (HPV) infection, which has contributed to rising incidence and improved survival in HPV-positive patients. There is an ongoing controversy regarding the optimal management of clinically node-negative cTxN0M0 OPSCC patients. Increasingly, less invasive and more conservative treatment strategies are being considered, aiming to maintain oncological safety while reducing surgical morbidity and impact on quality of life. OBJECTIVE: To determine whether a PET/CT-guided diagnostic approach, omitting elective neck dissection in PET/CT-negative cN0 OPSCC patients, is non-inferior to standard imaging with elective neck treatment regarding the 2-year regional nodal recurrence rate. DESIGN: Independent, prospective, multicentre, randomized, open-labelled, controlled, non-inferiority clinical trial conducted across 15 Spanish hospitals, all equipped with a multidisciplinary Head and Neck tumour board and PET/CT imaging. The multidisciplinary team includes otorhinolaryngologists, radiologists, pathologists, oncologists and nuclear medicine physicians. PARTICIPANTS: Patients diagnosed with clinically node-negative oropharyngeal squamous cell carcinoma (cTxN0M0 OPSCC). METHODS: A total of 704 patients will be consecutively recruited across the 15 participating hospitals. Participants will be randomly assigned into two groups: (A) standard imaging protocol followed by elective neck dissection, or (B) PET/CT-guided management without elective neck dissection in cN0 patients. The primary endpoint is the 2-year regional recurrence rate; secondary endpoints include disease-free survival, overall survival, and quality of life (QoL)

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