NCT05494190

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 111 (estimated)
• Sponsor: Eye & ENT Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypopharyngeal Carcinoma

Interventions

Type	Name	Description
DRUG	Docetaxel	60 mg/m2 i.v. day 1
DRUG	Cisplatin	60 mg/m2 i.v. day 1-3
DRUG	Capecitabine	750 mg/m2 po bid day 1-14
RADIATION	Concomitant chemoradiotherapy	Radiotherapy: using intensity-modulated radiation therapy (IMRT) Gross tumor volume (GTV) for primary tumor: 66-70 Gy in total, 2.0\~2.2 Gy per day, 5 days per week Clinical target volume (CTV) for lesions closely related to the primary lesion and metastatic lymph nodes: 65\~70 Gy in total, 1.7\~2.0 Gy per day, 5 days per week Prophylactic irradiation for sites of suspected subclinical spread: 50\~60 Gy in total, 1.7\~2.0 Gy per day, 5 days per week Concurrent chemotherapy: cisplatin 80 mg/m2 on days 1-3 every 3 weeks.
PROCEDURE	Surgery	Neck dissection and primary tumor resection

Timeline

• Start date: 2022-11-01
• Primary completion: 2027-11-01
• Completion: 2027-11-01
• First posted: 2022-08-09
• Last updated: 2025-12-30

Locations

3 sites across 1 country: China