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

NCT05494190 | Recruiting DMC

• 1 other identifier: EENTHN0706
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Hypopharyngeal Carcinoma

Keywords

Metastatic Neck Nodes; Induction Chemotherapy; Neck Dissection

Outcome Measures

Primary Outcomes (1)

• Progression-free survival rate

  The proportion of patients with disease progress or death due to any reasons.

  3 years

Secondary Outcomes (6)

• Overall survival rate

  3 years

• Local control

  3 years

• Regional control

  3 years

• Metastasis-free survival

  3 years

• Quality of life (UW-QOL V4.0)

  3 years

Study Arms (2)

Induction chemotherapy group

EXPERIMENTAL

Patients initially receive induction chemotherapy consisting of docetaxel, cisplatin and capecitabine (TPC), q3w, 2-3 cycles in total. Patients with regional response of complete reaction (CR)/partial reaction (PR)≥50% after induction chemotherapy then receive concomitant chemoradiotherapy for both the primary and regional sites. Patients with regional response of PR\<50%/stable disease (SD)/progressive disease (PD) after induction chemotherapy then receive surgery for both the primary and regional sites and postoperative concomitant chemoradiotherapy.

Drug: Docetaxel; Drug: Cisplatin; Drug: Capecitabine; Radiation: Concomitant chemoradiotherapy; Procedure: Surgery

Surgery group

ACTIVE COMPARATOR

Patients initially receive surgery for both the primary and regional sites and postoperative concomitant chemoradiotherapy.

Radiation: Concomitant chemoradiotherapy; Procedure: Surgery

Interventions

Docetaxel DRUG

60 mg/m2 i.v. day 1

Induction chemotherapy group

Cisplatin DRUG

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

Induction chemotherapy group

Capecitabine DRUG

750 mg/m2 po bid day 1-14

Induction chemotherapy group

Concomitant chemoradiotherapy RADIATION

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.

Induction chemotherapy group; Surgery group

Surgery PROCEDURE

Neck dissection and primary tumor resection

Induction chemotherapy group; Surgery group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Shandong Provincial Hospital: collaborator
• Harbin Medical University Third Affiliated Hospital: collaborator
• Eye & ENT Hospital of Fudan University: lead

Study Sites (3)

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150000, China

NOT YET RECRUITING

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

Jinan, Shandong, 250012, China

NOT YET RECRUITING

Eye & ENT Hospital, Fudan University

Shanghai, Shanghai Municipality, 200031, China

RECRUITING

MeSH Terms

Conditions

Hypopharyngeal Neoplasms

Interventions

Docetaxel; Cisplatin; Capecitabine; Chemoradiotherapy; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Study Officials

• Ming Zhang, PhD

  Eye & ENT Hospital, Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Feiran Li

CONTACT

8664377134; lifr214@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 6, 2022
• First Posted: August 9, 2022
• Study Start: November 1, 2022
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)