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RECRUITING
NCT05494190
NA

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

Sponsor: Eye & ENT Hospital of Fudan University

View on ClinicalTrials.gov

Summary

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

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

111

Start Date

2022-11-01

Completion Date

2027-11

Last Updated

2025-12-30

Healthy Volunteers

No

Interventions

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

Locations (3)

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Shandong Provincial ENT Hospital, Cheeloo College of Medicine, Shandong University

Jinan, Shandong, China

Eye & ENT Hospital, Fudan University

Shanghai, Shanghai Municipality, China