Submandibular Gland Preservation in Neck Dissection
1 other identifier
interventional
200
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 5, 2017
CompletedFirst Submitted
Initial submission to the registry
December 6, 2017
CompletedFirst Posted
Study publicly available on registry
December 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2030
ExpectedMarch 30, 2023
March 1, 2023
6 years
December 6, 2017
March 28, 2023
Conditions
Outcome Measures
Primary Outcomes (5)
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
Study Arms (2)
Experimental group
EXPERIMENTALControl group
ACTIVE COMPARATORInterventions
Modified neck dissection with preservation of submandibular gland. The submandibular gland is preserved during neck dissection.
traditional neck dissection without preservation of submandibular gland
Eligibility Criteria
You may qualify if:
- Primary oral squamous cell carcinoma of early stage (T1N0 and T2N0).
You may not qualify if:
- Cancer of the floor of the mouth.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Guang-Yan Yulead
- National Natural Science Foundation of Chinacollaborator
- Peking University School of Stomatologycollaborator
Study Sites (1)
Peking University School of Stomatology
Beijing, Beijing Municipality, 100081, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- President of Chinese Stomatological Association
Study Record Dates
First Submitted
December 6, 2017
First Posted
December 28, 2017
Study Start
December 5, 2017
Primary Completion
December 1, 2023
Study Completion (Estimated)
December 1, 2030
Last Updated
March 30, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share