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

Recruiting now · Not applicable

Conditions studied: Hypopharyngeal Carcinoma

In brief

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

Key facts

Study ID

NCT05494190

Run by

Eye & ENT Hospital of Fudan University

People needed

111

Starts

2022-11-01

Expected to finish

2027-11-01

Last updated by the study team

2025-12-30

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Able to understand and willing to sign a written informed consent document.
• Age ≥ 18 and ≤ 75 years.
• Male or female.
• Karnofsky physical status (KPS): ≥ 80
• Hepatic function, renal function and normal blood test. Hepatic function: Alanine aminotransferase (ALT) ≤ 2.5 upper limit of normal, Aspartate aminotransferase (AST) ≤ 2.5 upper limit of normal. Serum total bilirubin ≤ 1.5 upper limit of normal. Kidney function: Serum creatinine < upper limit of normal value and creatinine clearance rate > 60 ml/(min*1.73m2) (Cockcroft-Gault formula). Blood test: neutrophil (Neu) ≥ 1.5×109/L, platelet (PLT) ≥ 100×109/L, hemoglobin (HGB) ≥ 90 g/L.
• Pathologically diagnosed with squamous cell carcinoma of the hypopharynx.
• After clinical and radiographic evaluations, clinically classified as T1/2 N2/3 M0 stage according to American Joint Committee on Cancer (AJCC, eighth edition).
• Resectable regional metastatic lesion (incompletely tumor- wrapped carotid vascular).
• Assessable tumor lesions according to Response Evaluation Criteria in Solid Tumors (RECIST, Version 1.1).
• Radical treatment intent.
• Male patients with fertility and female patients with fertility and pregnancy risk must agree to use contraceptive methods throughout the study period, and continued until at least 6 months after the last dose of cisplatin. Female patients who do not have fertility (ie meet at least one of the following criteria): Have undergone hysterectomy and/or bilateral oophorectomy with archival records, medically confirmed ovarian function decline; In postmenopausal state. It is defined as: At least 12 months of continuous menstruation without other pathological or physiological reasons, and the status confirmed by serum follicle stimulating hormone (FSH) levels is consistent with postmenopausal status.
• Good compliance.

You may not qualify if…

• Distant metastatic disease
• Have a history of other cancers or coinstantaneous second primary tumor
• Previous treatment for the primary tumor, including radiotherapy, surgery except biopsy operation, chemotherapy, immunotherapy and biological targeted therapy.
• Patients who have participated in other clinical trials within 1 month before the test.
• Patients estimated to have poor tolerance to induction chemotherapy.
• The investigator believes that it is inappropriate for individuals to participate in the trial: having, for example, severe acute or chronic medical conditions (including immune colitis, inflammatory bowel disease, non-infectious pneumonia, pulmonary fibrosis) or mental illness (including recent time [within the past year] or active suicidal ideation or behavior).
• Palliative treatment intent.
• Pregnant or lactating women.

Where it is running

• Eye & ENT Hospital, Fudan University — Shanghai, Shanghai Municipality, China (enrolling)
• Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China
• Shandong Provincial ENT Hospital, Cheeloo College of Medicine, Shandong University — Jinan, Shandong, China

Full record on ClinicalTrials.gov

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