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).

JOURNAL OF CLINICAL ONCOLOGY(2015)

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摘要
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 ...
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