Checking the Neck or Removing Lymph Nodes in Early Mouth Cancer
Compares watching the neck with removing neck lymph nodes in adults with early mouth cancer.
Plain-language title generated from the registry record
Registry title: Neck Observation or Elective Neck Dissection in cT1N0M0 OSCC
Key facts
- Where
- Shanghai, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06623266, who can take part
Where in China
- Huashan Hospital, Fudan UniversityShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Huashan Hospital
- Trial code
- NCT06623266
- Record updated
- 21 September 2026
- Original 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.Read full original descriptionShow less
Neck Observation Versus Selective Neck Dissection in Patients With cT1N0M0 Oral Squamous Cell Carcinoma: A Multicenter Randomized Controlled Trial
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.
Inclusion: 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: History of previous head and neck radiotherapy; 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; 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; More than 2 lesions found in the oral cavity; Pregnant or lactating women; Other circumstances that the researcher considers unsuitable for participation in the study.