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

NCT05494190 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2025-12-30

No results posted yet for this study

Summary

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

Conditions

  • Hypopharyngeal Carcinoma

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

Sponsors & Collaborators

  • Shandong Provincial Hospital

    collaborator OTHER_GOV

  • Harbin Medical University Third Affiliated Hospital

    collaborator OTHER

  • Eye & ENT Hospital of Fudan University

    lead OTHER

Principal Investigators

  • Ming Zhang, PhD · Eye & ENT Hospital, Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2027-11-30
Completion
2027-11-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05494190 on ClinicalTrials.gov