RecruitingNot ApplicableNCT06623266

Neck Observation or Elective Neck Dissection in CT1N0M0 OSCC

Neck Observation Versus Selective Neck Dissection in Patients with CT1N0M0 Oral Squamous Cell Carcinoma: a Multicenter Randomized Controlled Trial

Sponsor

Huashan Hospital

Enrollment

300 participants

Start Date

Sep 26, 2024

Study Type

INTERVENTIONAL

Conditions

Lymph Node Metastasis Oral Cancer

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study compares two surgical approaches for treating early-stage oral squamous cell carcinoma (mouth cancer) — specifically whether to remove nearby lymph nodes in the neck as a precaution (elective neck dissection) or simply watch them closely (observation). This is for cancers that appear to not have spread to the neck yet. **You may be eligible if...** - You have been diagnosed with early-stage (cT1N0M0) squamous cell carcinoma in the mouth (tongue, gums, cheek lining, floor of mouth, hard palate, or back molar area) - Your cancer has been confirmed by pathology - You have given informed consent **You may NOT be eligible if...** - You have more than 2 lesions in the mouth - You have had another cancer in the past 5 years (unless fully cured for 5+ years) - You have had a prior neck dissection - You have had prior radiation to the head or neck - You are pregnant or breastfeeding - You have a severe uncontrolled infection or known HIV - You have had an organ, stem cell, or bone marrow transplant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURENeck 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.