This is a multi-center, multidisciplinary, open-label, randomized controlled prospective clinical study.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
111
60 mg/m2 i.v. day 1
60 mg/m2 i.v. day 1-3
750 mg/m2 po bid day 1-14
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
NOT_YET_RECRUITINGShandong Provincial ENT Hospital, Cheeloo College of Medicine, Shandong University
Jinan, Shandong, China
NOT_YET_RECRUITINGEye & ENT Hospital, Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGProgression-free survival rate
The proportion of patients with disease progress or death due to any reasons.
Time frame: 3 years
Overall survival rate
The proportion of dead patients due to any reasons.
Time frame: 3 years
Local control
The proportion of patients with local recurrence.
Time frame: 3 years
Regional control
The proportion of patients with regional recurrence.
Time frame: 3 years
Metastasis-free survival
The proportion of patients with distant metastasis.
Time frame: 3 years
Quality of life (UW-QOL V4.0)
Evaluated by University of Washington Quality of Life Questionnaire (UW-QOL) V4.0.
Time frame: 3 years
Adverse events
Evaluated by the NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE) V5.0.
Time frame: 3 years
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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.
Neck dissection and primary tumor resection