RecruitingNot ApplicableNCT05494190

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

Sponsor

Eye & ENT Hospital of Fudan University

Enrollment

111 participants

Start Date

Nov 1, 2022

Study Type

INTERVENTIONAL

Conditions

Hypopharyngeal Carcinoma

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating two different approaches for managing cancer that has spread to the lymph nodes in the neck in patients with locally advanced hypopharyngeal cancer (cancer of the lower throat). After chemoradiation, some patients may need surgery to remove remaining lymph nodes; this trial studies the optimal timing and selection for that surgery. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with squamous cell carcinoma of the hypopharynx (lower throat) - Your cancer stage is T1/2 N2/3 M0 (cancer in the throat with significant lymph node spread but no distant spread) - You have good liver, kidney, and blood count function - The lymph nodes in your neck are surgically removable - You are in good physical condition (Karnofsky score at least 80) **You may NOT be eligible if...** - You have distant spread of cancer - You have severe organ dysfunction - You are unable to give informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDocetaxel

60 mg/m2 i.v. day 1

DRUGCisplatin

60 mg/m2 i.v. day 1-3

DRUGCapecitabine

750 mg/m2 po bid day 1-14

RADIATIONConcomitant 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.

PROCEDURESurgery

Neck dissection and primary tumor resection