Clinical trial · Interventional
A Multicenter, Randomized, Case-control Study of Unilateral vs Bilateral Neck Dissection for cN0 Supraglottic Laryngeal Cancer
A Multicenter, Randomized, Case-control Study of Unilateral vs Bilateral Selective Neck Dissection for Clinically Negative Neck of Supraglottic Laryngeal Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Supraglottic laryngeal carcinoma patients with clinically negative neck (cN0) will be randomized divided into two groups. Patients in case group will undergo unilateral neck dissection (II-IV) while bilateral neck dissection (II-IV) in control group. Regional control rate is the primary endpoint and comparison will be made to see if unilateral dissection can get similar regional control as control group.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Laryngeal Neoplasms | Laryngeal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Malignant Neoplasm of Supraglottis Primary | — | UNRESOLVED | — |
| Neck Dislocation | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bilateral Neck Dissection | Procedure | — | UNRESOLVED |
| Unilateral Neck Dissection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- undergo unilateral (affected side) neck dissection (II-IV)
- description
- patient undergo affected side neck dissection, along with the excision of the laryngeal primary tumor
- interventionNames
- Procedure: Unilateral Neck Dissection
- type
- EXPERIMENTAL
- label
- undergo bilateral neck dissection (II-IV)
- description
- patient undergo bilateral neck dissection, along with the excision of the laryngeal primary tumor
- interventionNames
- Procedure: Bilateral Neck Dissection
Primary outcomes (1)
- measure
- Local-regional control
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. The patients obtain informed consent prior to any trial. 2. Diagnosis: Histopathology was confirmed to be squamous cell carcinoma. Classified by laryngoscopy as supraglottic, no tongue and deep pharyngeal invasion, and subglottic invasion. Also, no distant signs of metastasis. 3. Primary lesion is limited to one side, violation or more than midline, but preoperative laryngoscopy and CT can still clearly distinguish between the severity of bilateral lesions. 4. Evaluation of cN0: Patients need to undergo neck palpation, ultrasound and enhanced CT, if the patient is allergic to CT enhancer, replace it with MRI.Not touch more than 2cm hard lymph nodes in the neck, moreover, ultrasound and enhanced CT are not found lymph node that diameter ≥ 1cm.Or, the size does not meet the above criteria, but find rim enhancement, central irregular or hypodensity, and with the surrounding tissue boundary is obscure, and other suspicious transfer signs. 5. After multidisciplinary discussion, the preferred treatment for patients is surgical treatment. 6. Patients with no other previous head and neck cancer, and neck did not receive radiation therapy, no deep neck surgery, skin resection excepted. Exclusion Criteria: 1. Laryngeal carcinoma but not squamous cell carcinoma, or primary pathology includes non-squamous cell components. 2. Preoperative laryngoscopy assessment of primary lesions just in the middle or both sides of symmetry, can not distinguish which side is more serious. 3. No surgical indications, or initial treatment evaluation recommends non-surgical treatment. 4. The patient had other head and neck cancer.
References
Publications (0)
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