Clinical trial · Interventional
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
NCT06623266CI-TRIAL-00082560recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymph Node Metastasis | — | UNRESOLVED | — |
| Oral Cancer | Malignant Lip and Oral Cavity Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neck management | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Experimental arm
- description
- The patients in the experimental arm will receive 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. Ultrasonography, CT scan, and/or MRI examination will be used to detect lesions.
- interventionNames
- Procedure: Neck management
- type
- ACTIVE_COMPARATOR
- label
- Control arm
- description
- The patients in the control arm will receive radical resection of the primary lesion with the safety margins of the primary lesion are 1.0-1.5cm far away from the palpable margins of the lesion, they will also receive simultaneous elective neck dissection. Ultrasonography, CT scan, and/or MRI examination will be used to detect lesions.
- interventionNames
- Procedure: Neck management
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.