Submandibular Gland Preservation in Neck Dissection
Primary Purpose
Neck Dislocation, Oral Cancer
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
modified neck dissection
traditional neck dissection
Sponsored by
About this trial
This is an interventional treatment trial for Neck Dislocation
Eligibility Criteria
Inclusion Criteria:
Primary oral squamous cell carcinoma of early stage (T1N0 and T2N0).
Exclusion Criteria:
Cancer of the floor of the mouth.
Sites / Locations
- Peking University School of StomatologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental group
Control group
Arm Description
Outcomes
Primary Outcome Measures
5-year survival rate
disease free survival rate
3-year survival rate
disease free survival rate
5-year regional recurrence rate
rate of participants with tumor recurrence in the neck
3-year regional recurrence rate
rate of participants with tumor recurrence in the neck
1-year regional recurrence rate
rate of participants with tumor recurrence in the neck
Secondary Outcome Measures
Full Information
NCT ID
NCT03385720
First Posted
December 6, 2017
Last Updated
March 28, 2023
Sponsor
Guang-Yan Yu
Collaborators
National Natural Science Foundation of China, Peking University School of Stomatology
1. Study Identification
Unique Protocol Identification Number
NCT03385720
Brief Title
Submandibular Gland Preservation in Neck Dissection
Official Title
Submandibular Gland Preservation During Neck Dissection for Oral Squamous Cell Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 5, 2017 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2030 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Guang-Yan Yu
Collaborators
National Natural Science Foundation of China, Peking University School of Stomatology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Dislocation, Oral Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Title
Control group
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
modified neck dissection
Intervention Description
Modified neck dissection with preservation of submandibular gland. The submandibular gland is preserved during neck dissection.
Intervention Type
Procedure
Intervention Name(s)
traditional neck dissection
Intervention Description
traditional neck dissection without preservation of submandibular gland
Primary Outcome Measure Information:
Title
5-year survival rate
Description
disease free survival rate
Time Frame
5-year after operation
Title
3-year survival rate
Description
disease free survival rate
Time Frame
3-year after operation
Title
5-year regional recurrence rate
Description
rate of participants with tumor recurrence in the neck
Time Frame
5-year after operation
Title
3-year regional recurrence rate
Description
rate of participants with tumor recurrence in the neck
Time Frame
3-year after operation
Title
1-year regional recurrence rate
Description
rate of participants with tumor recurrence in the neck
Time Frame
1-year after operation
10. Eligibility
Sex
All
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Primary oral squamous cell carcinoma of early stage (T1N0 and T2N0).
Exclusion Criteria:
Cancer of the floor of the mouth.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jia-Zeng Su, Dr.
Phone
86 10 82195992
Email
sujiazeng@163.com
Facility Information:
Facility Name
Peking University School of Stomatology
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100081
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guang-Yan Yu, Professor
Phone
86 10 13426227717
Email
gyyu@263.net
12. IPD Sharing Statement
Plan to Share IPD
No
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Submandibular Gland Preservation in Neck Dissection
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