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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

About this trial

This is an interventional treatment trial for Neck Dislocation

Eligibility Criteria

undefined - 90 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Studies a U.S. FDA-regulated Device Product

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

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

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

gyyu@263.net

12. IPD Sharing Statement

Plan to Share IPD

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Submandibular Gland Preservation in Neck Dissection

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