Submandibular Gland Preservation in Neck Dissection

Oral Cancer Clinical Trial

Official title:

Submandibular Gland Preservation During Neck Dissection for Oral Squamous Cell Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03385720
• Other study ID #: sujiazeng
• Status: Recruiting
• Phase: N/A
• Start date: December 5, 2017
• Est. completion date: December 2030

Study information

• Verified date: March 2023
• Source: Peking University
• Contact: Jia-Zeng Su, Dr.
• Phone: 86 10 82195992
• Email: sujiazeng[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2030
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 90 Years

Eligibility

Inclusion Criteria:

Primary oral squamous cell carcinoma of early stage (T1N0 and T2N0).

Exclusion Criteria:

Cancer of the floor of the mouth.

Related Conditions & MeSH terms

• Mouth Neoplasms
• Neck Dislocation
• Oral Cancer

Intervention

Procedure:
• modified neck dissection
Modified neck dissection with preservation of submandibular gland. The submandibular gland is preserved during neck dissection.
• traditional neck dissection
traditional neck dissection without preservation of submandibular gland

Locations

Country	Name	City	State
China	Peking University School of Stomatology	Beijing	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Guang-Yan Yu	National Natural Science Foundation of China, Peking University School of Stomatology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	5-year survival rate	disease free survival rate	5-year after operation
Primary	3-year survival rate	disease free survival rate	3-year after operation
Primary	5-year regional recurrence rate	rate of participants with tumor recurrence in the neck	5-year after operation
Primary	3-year regional recurrence rate	rate of participants with tumor recurrence in the neck	3-year after operation
Primary	1-year regional recurrence rate	rate of participants with tumor recurrence in the neck	1-year after operation