NCT06623266Recruiting
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
Source: ClinicalTrials.gov · Last updated 21 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 29 Sept 2024
- Start date
- 26 Sept 2024
- Primary completion date
- 30 Sept 2028
- Lead sponsor
- Huashan Hospital
- Diseases
- Head and neck cancer
- NCT number
- NCT06623266
What you commit to
- Study type: Interventional
- Planned participants: 300
- From 26 Sept 2024 to the primary completion date, 30 Sept 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Huashan Hospital, Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.