Neck Dislocation, Oral Cancer
Conditions
Brief summary
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
Interventions
PROCEDUREmodified neck dissection
Modified neck dissection with preservation of submandibular gland. The submandibular gland is preserved during neck dissection.
PROCEDUREtraditional neck dissection
traditional neck dissection without preservation of submandibular gland
Sponsors
National Natural Science Foundation of China
Peking University School of Stomatology
Guang-Yan Yu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
No minimum to 90 Years
Healthy volunteers
No
Inclusion criteria
Primary oral squamous cell carcinoma of early stage (T1N0 and T2N0).
Exclusion criteria
Cancer of the floor of the mouth.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 5-year survival rate | 5-year after operation | disease free survival rate |
| 3-year survival rate | 3-year after operation | disease free survival rate |
| 5-year regional recurrence rate | 5-year after operation | rate of participants with tumor recurrence in the neck |
| 3-year regional recurrence rate | 3-year after operation | rate of participants with tumor recurrence in the neck |
| 1-year regional recurrence rate | 1-year after operation | rate of participants with tumor recurrence in the neck |
Countries
China
Contacts
Primary ContactJia-Zeng Su, Dr.
Outcome results
None listed