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| Name | Class |
|---|---|
| Shandong Provincial Hospital | OTHER_GOV |
| Harbin Medical University Third Affiliated Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Surgery group | Active Comparator | Patients initially receive surgery for both the primary and regional sites and postoperative concomitant chemoradiotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel | Drug | 60 mg/m2 i.v. day 1 |
| |
| Cisplatin |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival rate | The proportion of patients with disease progress or death due to any reasons. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival rate | The proportion of dead patients due to any reasons. | 3 years |
| Local control | The proportion of patients with local recurrence. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Feiran Li | Contact | 8664377134 | lifr214@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Ming Zhang, PhD | Eye & ENT Hospital, Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harbin Medical University Cancer Hospital | Not yet recruiting | Harbin | Heilongjiang | 150000 | China |
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| ID | Term |
|---|---|
| D007012 | Hypopharyngeal Neoplasms |
| ID | Term |
|---|---|
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D002945 | Cisplatin |
| D000069287 | Capecitabine |
| D059248 | Chemoradiotherapy |
| D013514 | Surgical Procedures, Operative |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Drug |
60 mg/m2 i.v. day 1-3 |
|
| Capecitabine | Drug | 750 mg/m2 po bid day 1-14 |
|
| 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. |
|
| Surgery | Procedure | Neck dissection and primary tumor resection |
|
| 3 years |
| Regional control | The proportion of patients with regional recurrence. | 3 years |
| Metastasis-free survival | The proportion of patients with distant metastasis. | 3 years |
| Quality of life (UW-QOL V4.0) | Evaluated by University of Washington Quality of Life Questionnaire (UW-QOL) V4.0. | 3 years |
| Adverse events | Evaluated by the NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE) V5.0. | 3 years |
| Shandong Provincial ENT Hospital, Cheeloo College of Medicine, Shandong University | Not yet recruiting | Jinan | Shandong | 250012 | China |
|
| Eye & ENT Hospital, Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200031 | China |
|
| D009369 | Neoplasms |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |