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Recruiting NCT03385720

Submandibular Gland Preservation in Neck Dissection

No phase Interventional Neck Dislocation Oral Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: modified neck dissection, traditional neck dissection.
Who it may be relevant to
Registry conditions: Neck Dislocation, Oral Cancer. Basic parameters: up to 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Submandibular Gland Preservation During Neck Dissection for Oral Squamous Cell Carcinoma

Overview

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

Interventions

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

Primary outcome measures

  • 5-year survival rate [Time frame: 5-year after operation]
  • 3-year survival rate [Time frame: 3-year after operation]
  • 5-year regional recurrence rate [Time frame: 5-year after operation]
  • 3-year regional recurrence rate [Time frame: 3-year after operation]
  • 1-year regional recurrence rate [Time frame: 1-year after operation]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

Cancer of the floor of the mouth.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Peking University School of Stomatology — Beijing

Identifiers

NCT: NCT03385720 · sujiazeng

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗