Actively Recruiting
Neck Observation Versus Selective Neck Dissection in Patients with CT1N0M0 Oral Squamous Cell Carcinoma: a Multicenter Randomized Controlled Trial
Led by Huashan Hospital · Updated on 2024-11-14
300
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical outcomes in patients with cT1N0M0 oral squamous cell carcinoma (OSCC) who receive either primary lesion resection combined with elective neck dissection or primary lesion resection only. The study aims to compare the 2-year lymph node metastasis rate, disease-free survival, overall survival, and health-related quality of life between these two approaches. The trial involves 300 patients, divided equally between the two treatment groups, to provide insight into the benefits and risks of neck management strategies in OSCC. Participants in the experimental arm will undergo radical resection of the primary lesion only, with neck observation, maintaining safety margins of 1.0-1.5 cm from the lesion's palpable edges. The control arm will receive radical resection of the primary lesion with similar safety margins plus elective neck dissection during the same surgery. Both groups will have lesion detection performed using ultrasonography, CT scan, and/or MRI. Follow-up visits will be conducted every two months for at least two years, focusing on lymph node metastasis and local recurrence. During the study, patients will have a complete medical history taken and tumor assessment at baseline. Follow-ups will occur every three months for the first two years, every six months for the next 3 to 5 years, and annually thereafter until death or data censoring. Researchers will collect and analyze data on lymph node metastasis rate, disease-free survival, overall survival, and health-related quality of life over two years. Continuous monitoring with imaging and clinical evaluations will support this comprehensive assessment of patient outcomes.
CONDITIONS
Brief Title
Neck Observation or Elective Neck Dissection in CT1N0M0 OSCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Tumor site in tongue, gingiva, buccal mucosa, floor of mouth, hard palate, or retromolar area
- Clinical stage cT1N0M0 according to AJCC 8th edition
- Pathological diagnosis of squamous cell carcinoma
- Signed informed consent form
You will not qualify if you...
- More than 2 lesions found in the oral cavity
- History of malignant tumor within five years unless fully treated with no recurrence
- Previous unilateral or bilateral neck dissection
- Prior head and neck radiotherapy
- Pregnant or lactating women
- Severe uncontrolled infection, known HIV infection, or prior organ, stem cell, or bone marrow transplant
- Participation in other clinical studies within 30 days before enrollment
- Any other condition the researcher considers unsuitable for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single surgical procedure
Participants undergo surgical resection of the primary lesion. Some participants also receive elective neck dissection depending on their assigned group.
1 surgical visit (in-person)
Duration - At least 2 years
Participants are closely monitored after surgery with regular imaging and clinical assessments to detect lymph node metastasis and local recurrence.
Visits every 2 months for at least 2 years
Trial Site Locations
Total: 1 location
1
Huashan Hospital, Fudan University
Shanghai, China, 200040
Actively Recruiting
Research Team
L
Lai-ping Zhong, MD, PhD
L
Liang Gu, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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