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

Inclusion Criteria12

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.

Exclusion Criteria8

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.

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