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Neck Observation or Elective Neck Dissection in CT1N0M0 OSCC
Sponsor: Huashan Hospital
Summary
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.
Official title: Neck Observation Versus Selective Neck Dissection in Patients with CT1N0M0 Oral Squamous Cell Carcinoma: a Multicenter Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2024-09-26
Completion Date
2028-09-30
Last Updated
2024-11-14
Healthy Volunteers
No
Conditions
Interventions
Neck management
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.
Locations (1)
Huashan Hospital, Fudan University
Shanghai, China