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Neck Observation or Elective Neck Dissection in cT1N0M0 OSCC

Sponsor: Huashan Hospital • ClinicalTrials.gov ID: NCT06623266

Registry updated: 2026-09-21

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Description

To evaluate the clinical outcomes of 2-year lymph node metastasis rate, disease-free survival, overall survival, and health-related quality of life in the patients with cT1N0M0 oral squamous cell carcinoma, who receive primary lesion resection combined with elective neck dissection or primary lesion resection only.

Interventions

Neck management (Procedure)
In the experimental arm: the neck management is neck observation, simultaneous elective neck dissection is not performed during the surgical resection of primary lesion. The patients will be followed up every two months for at least two years, focusing on the lymph node metastasis and local recurrence. Ultrasonography, CT scan, and/or MRI will be used to detect lesions. In the control arm: the neck management is elective neck dissection. Simultaneous elective neck dissection is performed during the surgical resection of primary lesion. The patients will be followed up every two months for at least two years, focusing on the lymph node metastasis and local recurrence. Ultrasonography, CT scan, and/or MRI will be used to detect lesions.

Eligibility criteria

Inclusion Criteria: * Tumor site: tongue, gingiva, buccal mucosa, floor of mouth, hard palate, retromolar eara * Clinical stage is cT1N0M0 (AJCC 8th edition) * Pathological diagnosis of squamous cell carcinoma * Sign the informed consent form Exclusion Criteria: * More than 2 lesions found in the oral cavity * Known history of malignant tumor within five years (unless the patient has undergone curative treatment and there is no disease recurrence within 5 years since the start of treatment) * History of unilateral or bilateral neck dissection in the past * History of previous head and neck radiotherapy * Pregnant or lactating women * Severe, uncontrolled infection or known HIV infection; or previous organ transplantation, stem cell or bone marrow transplantation * Participated in other clinical studies within 30 days before enrollment * Other circumstances that the researcher considers unsuitable for participation in the study

Conditions

Oral Cancer Lymph Node Metastasis

Locations

Huashan Hospital, Fudan University — Shanghai, China

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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