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| Name | Class |
|---|---|
| Tianjin Medical University General Hospital | OTHER |
| Tianjin Medical University Second Hospital | OTHER |
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Supraglottic cancer is a main type of laryngeal carcinoma, which is one of the most common head and neck tumors. Cervical nodal metastasis is an important prognostic factor in supraglottic cancer. Current management, following the US National Comprehensive Cancer Network guidelines for T1-2, N0 supraglottic cancer (NCCN 2017), is either definitive radiotherapy or primary surgery with or without neck dissection. The optimal neck treatments strategy remains unclear in clinical settings owing to the limitation of a small number of retrospective studies and a lack of prospective trials. The investigators conducted a prospective, randomised trial to compare radiotherapy with neck dissection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiotherapy | Experimental | Radiotherapy & open partial supraglottic laryngectomy(primary tumor) |
|
| Elective neck dissection | Active Comparator | Elective neck dissection & open partial supraglottic laryngectomy(primary tumor) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiotherapy | Radiation | Radiotherapy with a dose of 66-70 Gy is used to manage the cervical lymph nodes |
|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dong Xu Wang, Ph.D | Contact | +86 022 23340123 | wxd.1133@163.com | |
| Ze Zhang, MD | Contact | +86 022 23340123 | zhangze_smu@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Lun Zhang, Ph.D | Tianjin Medical University Cancer Institute and Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Institute and Hopital | Tianjin | Tianjin Municipality | 300000 | China |
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| ID | Term |
|---|---|
| D007822 | Laryngeal Neoplasms |
| ID | Term |
|---|---|
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Selective neck dissection | Procedure | Selective neck dissection, defined as surgical clearance of the upper jugular (leveI II), midjugular (level III) and sometimes submandibular (level I) nodes, is used to manage the cervical lymph nodes |
|
| 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 (EORTC QLQ-C30) | Evaluated by the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 | 1 year |
| Quality of life (EORTC QLQ-HN35) | Evaluated by the European Organization for Research and Treatment of Cancer (EORTC) QLQ-HN35 | 1 year |
| Treatment cost | The total cost of the treatment of the primary and cervical lymph nodes until the discharge | 4 weeks |
| D007818 |
| Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D010038 | Otorhinolaryngologic Diseases |