Managing metastatic neck nodes in hypopharyngeal cancer

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

This study is testing whether surgery or chemotherapy works better for patients with advanced hypopharyngeal cancer that has spread to their neck nodes.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 111 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Eye & ENT Hospital of Fudan University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 3 sites (Harbin, Heilongjiang and 2 other locations)
• Trial ID: NCT05494190 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to determine the most effective treatment strategy for patients with hypopharyngeal squamous cell carcinoma (HPSCC) who have bulky metastatic neck nodes classified as N2/3. It is a multi-center, open-label, randomized controlled study that will enroll 111 patients. Participants will be divided into two groups: one receiving surgery and the other undergoing induction chemotherapy. Depending on their response to treatment, patients will either continue with surgery or receive concomitant chemoradiotherapy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with pathologically diagnosed hypopharyngeal squamous cell carcinoma classified as T1/2 N2/3 M0.

Not a fit: Patients with non-resectable metastatic lesions or those outside the age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve survival outcomes for patients with advanced hypopharyngeal cancer by optimizing treatment strategies.

How similar studies have performed: Other studies have shown promise in managing metastatic neck nodes in head and neck cancers, suggesting that this approach may yield beneficial results.

Eligibility criteria

Inclusion Criteria:

1. Able to understand and willing to sign a written informed consent document.
2. Age ≥ 18 and ≤ 75 years.
3. Male or female.
4. Karnofsky physical status (KPS): ≥ 80
5. 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.
6. Pathologically diagnosed with squamous cell carcinoma of the hypopharynx.
7. After clinical and radiographic evaluations, clinically classified as T1/2 N2/3 M0 stage according to American Joint Committee on Cancer (AJCC, eighth edition).
8. Resectable regional metastatic lesion (incompletely tumor- wrapped carotid vascular).
9. Assessable tumor lesions according to Response Evaluation Criteria in Solid Tumors (RECIST, Version 1.1).
10. Radical treatment intent.
11. 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.
12. Good compliance.

Exclusion Criteria:

1. Distant metastatic disease
2. Have a history of other cancers or coinstantaneous second primary tumor
3. Previous treatment for the primary tumor, including radiotherapy, surgery except biopsy operation, chemotherapy, immunotherapy and biological targeted therapy.
4. Patients who have participated in other clinical trials within 1 month before the test.
5. Patients estimated to have poor tolerance to induction chemotherapy.
6. 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).
7. Palliative treatment intent.
8. Pregnant or lactating women.

Where this trial is running

Harbin, Heilongjiang and 2 other locations

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

Study contacts

• Principal investigator: Ming Zhang, PhD — Eye & ENT Hospital, Fudan University
• Study coordinator: Feiran Li

Conditions Hypopharyngeal Carcinoma; Metastatic Neck Nodes; Induction Chemotherapy; Neck Dissection