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| Name | Class |
|---|---|
| Tianjin Medical University Second Hospital | OTHER |
| Tianjin Medical University General Hospital | OTHER |
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At the time of diagnosis, approximately 60%-80% of patients with hypopharyngeal cancer are found with cervical lymph node metastasis. Cervical nodal metastasis is an important prognostic factor in hypopharyngeal cancer. Induction chemotherapy is frequently used in advanced hypopharynx cancer. However, sometimes CR was obtained at the tumor's primary site but not in the palpable lymph nodes in the neck, the large cervical lymph node metastasis poorly responded to induction chemotherapy in a considerable percentage of patients. At present, patients with primary tumor achieved CR preferred to receive definitive radiotherapy no matter cervical lymph node metastasis SD or progression. But, radiotherapy was poor effective to the big cervical lymph node metastasis, because the inner of big cervical lymph node metastasis was hypoxic and necrosis. The investigators conducted a prospective, randomised trial to compare neck dissection with definitive radiotherapy for advanced hypopharyngeal cancer cervical lymph node metastasis with poor response to induction chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neck dissection group | Experimental | Neck dissection followed by radiotherapy(50Gy) according to risk factors |
|
| Radiotherapy group | Active Comparator | Definitive radiotherapy (70Gy) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neck dissection followed by radiotherapy(50Gy) according to risk factors | Procedure | Neck dissection followed by radiotherapy(50Gy) according to risk factors |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neck control rates | The percentage of patients without cervical lymph node metastasis | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival | The proportion of patients did not find clear evidence of recurrence or metastasis | 1 year |
| Disease-free survival | The proportion of patients did not find clear evidence of recurrence or metastasis |
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Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuansheng Duan, MD | Contact | +86 022 23340123 | duanyuansheng89@163.com | |
| Ze Zhang, MD | Contact | +86 022 23340123 | zhangze_smu@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xudong Wang, Ph.D | Tianjin Medical University Cancer Institute and Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Institute and Hospital | Tianjin | Tianjin Municipality | 300000 | China |
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| Definitive radiotherapy | Radiation | Definitive radiotherapy (70Gy) |
|
| 2 years |
| Disease-free survival | The proportion of patients did not find clear evidence of recurrence or metastasis | 3 years |
| Disease-free survival | The proportion of patients did not find clear evidence of recurrence or metastasis | 5 years |
| Overall survival | The proportion of patients who survived | 3 years |
| Overall survival | The proportion of patients who survived | 5 years |
| Quality of life(QOL) QLQ-C30 | Evaluated by the European Organization for Research and Treatment of Cancer(EORTC)QLQ-C30 | 1 year |
| Quality of life(QOL) QLQ-HN35 | Evaluated by the European Organization for Research and Treatment of Cancer(EORTC) QLQ-HN35 | 1 year |
| ID | Term |
|---|---|
| D007012 | Hypopharyngeal Neoplasms |
| ID | Term |
|---|---|
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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