Submandibular Gland Preservation in Neck Dissection

March 28, 2023 updated by: Guang-Yan Yu

Submandibular Gland Preservation During Neck Dissection for Oral Squamous Cell Carcinoma

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100081
        • Recruiting
        • Peking University School of Stomatology
        • Contact:
          • Guang-Yan Yu, Professor
          • Phone Number: 86 10 13426227717
          • Email: gyyu@263.net

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

Cancer of the floor of the mouth.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group
Procedure: traditional neck dissection
traditional neck dissection without preservation of submandibular gland
Experimental: Experimental group
Procedure: modified neck dissection
Modified neck dissection with preservation of submandibular gland. The submandibular gland is preserved during neck dissection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
5-year survival rate
Time Frame: 5-year after operation
disease free survival rate
5-year after operation
3-year survival rate
Time Frame: 3-year after operation
disease free survival rate
3-year after operation
5-year regional recurrence rate
Time Frame: 5-year after operation
rate of participants with tumor recurrence in the neck
5-year after operation
3-year regional recurrence rate
Time Frame: 3-year after operation
rate of participants with tumor recurrence in the neck
3-year after operation
1-year regional recurrence rate
Time Frame: 1-year after operation
rate of participants with tumor recurrence in the neck
1-year after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guang-Yan Yu

Collaborators

National Natural Science Foundation of China
Peking University School of Stomatology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2017

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2030

Study Registration Dates

First Submitted

December 6, 2017

First Submitted That Met QC Criteria

December 20, 2017

First Posted (Actual)

December 28, 2017

Study Record Updates

Last Update Posted (Actual)

March 30, 2023

Last Update Submitted That Met QC Criteria

March 28, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • sujiazeng

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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