Spots Global Cancer Trial Database for The Management of Metastatic Neck Nodes in N2/3 Hypopharyngeal Squamous Cell Carcinoma

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Trial Identification

Brief Title: The Management of Metastatic Neck Nodes in N2/3 Hypopharyngeal Squamous Cell Carcinoma

Official Title: The Management of Metastatic Neck Nodes in N2/3 Hypopharyngeal Squamous Cell Carcinoma: A Multi-center Randomized Controlled Prospective Study

Study ID: NCT05494190

Conditions

Hypopharyngeal Carcinoma

Interventions

Docetaxel

Cisplatin

Capecitabine

Concomitant chemoradiotherapy

Surgery

Study Description

Brief Summary: This is a multi-center, multidisciplinary, open-label, randomized controlled prospective clinical study.

Detailed Description: Hypopharyngeal squamous cell carcinoma (HPSCC) is prone to have regional metastasis, which is an established negative prognostic factor. Especially for N2/3 patients whose metastatic neck nodes are bulky and have multiple or extracapsular spreads, their survival outcome is even worse. Therefore, it is vital for clinicians to select proper treatment and further improve the prognosis of N2/3 HPSCC patients. The aim of this randomized controlled prospective study is to explore the suitable treatment strategy of metastatic neck nodes in N2/3 HPSCC. This study will enroll a total of 111 HPSCC patients, who are clinically classified as T1/2 N2/3 M0 stage and initially treated with surgery (group 1) or induction chemotherapy (group 2). For patients with the regional response of PR\<50%/SD/PD after induction chemotherapy, their following treatment will be surgery for both the primary and regional sites. For patients with the regional response of CR/PR≥50%, the following treatment will be concomitant chemoradiotherapy for both the primary and regional sites.