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

NCT ID: NCT05494190

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2027-11-30

Brief Summary

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

Detailed Description

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Hypopharyngeal squamous cell carcinoma (HPSCC) is prone to have regional metastasis, which is an established negative prognostic factor. Especially for N2/3 patients whose metastatic neck nodes are bulky and have multiple or extracapsular spreads, their survival outcome is even worse. Therefore, it is vital for clinicians to select proper treatment and further improve the prognosis of N2/3 HPSCC patients. The aim of this randomized controlled prospective study is to explore the suitable treatment strategy of metastatic neck nodes in N2/3 HPSCC. This study will enroll a total of 111 HPSCC patients, who are clinically classified as T1/2 N2/3 M0 stage and initially treated with surgery (group 1) or induction chemotherapy (group 2). For patients with the regional response of PR\<50%/SD/PD after induction chemotherapy, their following treatment will be surgery for both the primary and regional sites. For patients with the regional response of CR/PR≥50%, the following treatment will be concomitant chemoradiotherapy for both the primary and regional sites.

Conditions

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Hypopharyngeal Carcinoma

Keywords

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Metastatic Neck Nodes Induction Chemotherapy Neck Dissection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Induction chemotherapy group

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.

Group Type EXPERIMENTAL

Docetaxel

Intervention Type DRUG

60 mg/m2 i.v. day 1

Cisplatin

Intervention Type DRUG

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

Capecitabine

Intervention Type DRUG

750 mg/m2 po bid day 1-14

Concomitant chemoradiotherapy

Intervention Type 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.

Surgery

Intervention Type PROCEDURE

Neck dissection and primary tumor resection

Surgery group

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

Group Type ACTIVE_COMPARATOR

Concomitant chemoradiotherapy

Intervention Type 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.

Surgery

Intervention Type PROCEDURE

Neck dissection and primary tumor resection

Interventions

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Docetaxel

60 mg/m2 i.v. day 1

Intervention Type DRUG

Cisplatin

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

Intervention Type DRUG

Capecitabine

750 mg/m2 po bid day 1-14

Intervention Type DRUG

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.

Intervention Type RADIATION

Surgery

Neck dissection and primary tumor resection

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shandong Provincial Hospital

OTHER_GOV

Sponsor Role collaborator

Harbin Medical University Third Affiliated Hospital

OTHER

Sponsor Role collaborator

Eye & ENT Hospital of Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Ming Zhang

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ming Zhang, PhD

Role: PRINCIPAL_INVESTIGATOR

Eye & ENT Hospital, Fudan University

Locations

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Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Site Status NOT_YET_RECRUITING

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

Jinan, Shandong, China

Site Status NOT_YET_RECRUITING

Eye & ENT Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Feiran Li

Role: CONTACT

Phone: 8664377134

Email: [email protected]

Facility Contacts

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Susheng Miao, PhD

Role: primary

Zhenghua Lv, PhD

Role: primary

Ming Zhang, PhD

Role: primary

Other Identifiers

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EENTHN0706

Identifier Type: -

Identifier Source: org_study_id