Neck Observation or Elective Neck Dissection in CT1N0M0 OSCC

Trial Title: Neck Observation or Elective Neck Dissection in CT1N0M0 OSCC

NCT ID: NCT06623266

Condition: Oral Cancer
Lymph Node Metastasis

Conditions: Official terms:
Neoplasm Metastasis
Lymphatic Metastasis
Mouth Neoplasms
Squamous Cell Carcinoma of Head and Neck

Conditions: Keywords:
Oral squamous cell carcinoma
Early stage
Neck dissection
Neck observation
Lymph node metastasis rate

Study type: Interventional

Study phase: N/A

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Randomized 1:1 to the experimental or control arm. Experimental arm: radical resection of the primary lesion only, with neck observation, the safety margins of the primary lesion are 1.0-1.5cm far away from the palpable margins of the lesion. Control arm: radical resection of the primary lesion with 1.0-1.5cm safety margins, and elective neck dissection.

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: Neck management
Description: 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.
Arm group label: Control arm
Arm group label: Experimental arm

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.

Detailed description: For the patients with cT1N0M0 oral squamous cell carcinoma (OSCC), surgical resection of primary lesion is the preferred treatment. However, there are still debates on the neck management, some surgeons suggest elective neck dissection (END), and some surgeons suggest neck observation (NOB). The advantage of elective neck dissection is to clear the potential occult neck lymph node metastasis (about 15%), which could not be detected by clinical examination and imaging examination, and the disadvantage of END is to cause neck deformity, large scars, stiff neck and shoulders, difficulty in raising shoulders, and increase medical costs. The disadvantage of NOB is the risk of lymph node metastasis and disease progression. However, recent retrospective studies show that END has no potential benefit in improving survival in cT1N0M0 patients. The aim of the present trial is to compare the clinical outcomes between the cT1N0M0 OSCC patients, who receive primary lesion resection combined with elective neck dissection or primary lesion resection only, on the aspects of 2-year lymph node metastasis rate, disease-free survival, overall survival, and health-related quality of life. A total number of 300 patients will be recruited, including 150 patients in the experimental arm and 150 patients in the control arm. Experimental arm: radical resection of the primary lesion only, with neck observation, the safety margins of the primary lesion are 1.0-1.5cm far away from the palpable margins of the lesion. Control arm: radical resection of the primary lesion with 1.0-1.5cm safety margins, and elective neck dissection. A complete medical history will be obtained and tumor assessment will be performed at baseline. Patients will be followed-up by every three months in the first 2 years, every six months in the next 3-5 years, and once a year thereafter until death or data censoring. Two-year lymph node metastasis rate, disease-free survival, overall survival, and health-related quality of life will be collected and analyzed.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Huashan Hospital, Fudan University

Address:
City: Shanghai
Zip: 200040
Country: China

Start date: September 26, 2024

Completion date: September 30, 2028

Lead sponsor:
Agency: Huashan Hospital
Agency class: Other

Source: Huashan Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06623266