Neoplasms

All Conditions

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Head and Neck Neoplasms

Hypopharyngeal Cancer

Antineoplastic Agents

All Drugs and Chemicals

Capecitabine

Docetaxel

Cisplatin

Tubulin Modulators

Antimitotic Agents

Antimetabolites

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.

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

Concomitant chemoradiotherapy

Neck dissection and primary tumor resection

Surgery

Feiran Li

Susheng Miao, PhD

Zhenghua Lv, PhD

Ming Zhang, PhD

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.

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

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

The proportion of dead patients due to any reasons.

The proportion of patients with local recurrence.

The proportion of patients with regional recurrence.

The proportion of patients with distant metastasis.

Evaluated by University of Washington Quality of Life Questionnaire (UW-QOL) V4.0.

Evaluated by the NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE) V5.0.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
The Management of Metastatic Neck Nodes in N2/3 Hypopharyngeal Squamous Cell Carcinoma	NCT05494190	Hypopharyngeal ...	Docetaxel Cisplatin Capecitabine Concomitant che... Surgery	18 Years - 75 Years	Eye & ENT Hospital of Fudan University
The Management of Metastatic Neck Nodes in N2/3 Hypopharyngeal Squamous Cell Carcinoma	NCT05494190	Hypopharyngeal ...	Docetaxel Cisplatin Capecitabine Concomitant che... Surgery	18 Years - 75 Years	Eye & ENT Hospital of Fudan University

Spots Global Cancer Trial Database for metastatic neck nodes