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| Name | Class |
|---|---|
| National Natural Science Foundation of China | OTHER_GOV |
| Peking University School of Stomatology | UNKNOWN |
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Trial design: a randomized controlled trial.
Eligibility criteria for participants: patients with primary early stage oral squamous cell carcinoma. Exclusion criteria: cancer of the floor of the mouth.
Interventions: submandibular gland is preserved during neck dissection for patients of the experimental group; submandibular gland is removed during neck dissection for patients of the control group.
Primary Parameters: survival rate, mortality rate
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental |
| |
| Control group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| modified neck dissection | Procedure | Modified neck dissection with preservation of submandibular gland. The submandibular gland is preserved during neck dissection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 5-year survival rate | disease free survival rate | 5-year after operation |
| 3-year survival rate | disease free survival rate | 3-year after operation |
| 5-year regional recurrence rate | rate of participants with tumor recurrence in the neck | 5-year after operation |
| 3-year regional recurrence rate | rate of participants with tumor recurrence in the neck | 3-year after operation |
| 1-year regional recurrence rate | rate of participants with tumor recurrence in the neck | 1-year after operation |
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Inclusion Criteria:
Primary oral squamous cell carcinoma of early stage (T1N0 and T2N0).
Exclusion Criteria:
Cancer of the floor of the mouth.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jia-Zeng Su, Dr. | Contact | 86 10 82195992 | sujiazeng@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University School of Stomatology | Recruiting | Beijing | Beijing Municipality | 100081 | China |
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| ID | Term |
|---|---|
| D009062 | Mouth Neoplasms |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009059 | Mouth Diseases |
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| traditional neck dissection | Procedure | traditional neck dissection without preservation of submandibular gland |
|
| D009057 |
| Stomatognathic Diseases |