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NCT Number: NCT03385720

Submandibular Gland Preservation in Neck Dissection

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

Recruiting

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Key information

Conditions

Neck Dislocation Head and Neck Neoplasms Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Site Oral Cancer Stomatognathic Diseases

Age range

Up to 90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University School of Stomatology

Beijing, Beijing Municipality, 100081, China

Location status: Recruiting

Location contact

Guang-Yan Yu, Professor

CONTACT

[email protected]

86 10 13426227717

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Cancer of the floor of the mouth.

Treatment and study plan

modified neck dissection

Procedure

Modified neck dissection with preservation of submandibular gland. The submandibular gland is preserved during neck dissection.

traditional neck dissection

Procedure

traditional neck dissection without preservation of submandibular gland

Primary outcomes

  1. 5-year survival rate

    Time frame: 5-year after operation

    disease free survival rate

  2. 3-year survival rate

    Time frame: 3-year after operation

    disease free survival rate

  3. 5-year regional recurrence rate

    Time frame: 5-year after operation

    rate of participants with tumor recurrence in the neck

  4. 3-year regional recurrence rate

    Time frame: 3-year after operation

    rate of participants with tumor recurrence in the neck

  5. 1-year regional recurrence rate

    Time frame: 1-year after operation

    rate of participants with tumor recurrence in the neck

Study contacts

Contact information is provided by the study sponsor or research team.

Jia-Zeng Su, Dr.

CONTACT

[email protected]

86 10 82195992

Sponsors and collaborators

Lead sponsor

Guang-Yan Yu

Other

Collaborators

  • National Natural Science Foundation of China
  • Peking University School of Stomatology

Registry information

Official study title

Submandibular Gland Preservation During Neck Dissection for Oral Squamous Cell Carcinoma

Important dates

Study start
2017
Primary completion
2023
Study completion
2030
First posted
Dec 28, 2017
Registry last updated
Mar 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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