Clinical trial · Interventional
Radiotherapy vs Neck Dissection for Clinical T1/2N0 Supraglottic Cancer
Radiotherapy Versus Elective Neck Dissection for Management of Cervical Nodes in Clinical T1/2N0 Supraglottic Squamous Cell 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 cancer is a main type of laryngeal carcinoma, which is one of the most common head and neck tumors. Cervical nodal metastasis is an important prognostic factor in supraglottic cancer. Current management, following the US National Comprehensive Cancer Network guidelines for T1-2, N0 supraglottic cancer (NCCN 2017), is either definitive radiotherapy or primary surgery with or without neck dissection. The optimal neck treatments strategy remains unclear in clinical settings owing to the limitation of a small number of retrospective studies and a lack of prospective trials. The investigators conducted a prospective, randomised trial to compare radiotherapy with neck dissection.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Supraglottic Cancer | Laryngeal Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiotherapy | Radiation | — | UNRESOLVED |
| Selective neck dissection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Radiotherapy
- description
- Radiotherapy \& open partial supraglottic laryngectomy(primary tumor)
- interventionNames
- Radiation: Radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- Elective neck dissection
- description
- Elective neck dissection \& open partial supraglottic laryngectomy(primary tumor)
- interventionNames
- Procedure: Selective neck dissection
Primary outcomes (1)
- measure
- Neck control rates
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Ability to understand and the willingness to sign a written informed consent document 2. Age≥ 18 and≤ 75 years 3. Histological/ cytological/ Imaging examination proven supraglottic squamous-cell carcinoma in preoperative assessment 4. Cervical node negative according to the imaging characteristics and the physical examination 5. KPS≥ 70 6. Normal bone marrow reserve function and normal liver, kidney function 7. Expected survival period≥ 12 months Exclusion Criteria: 1. Inability to provide an informed consent 2. Proved distant metastasis 3. Clinical stage 3-4 4. The patient has received prior surgery or radiotherapy (except for biopsy ) 5. The patient has received chemotherapy(including targeted therapies) or immunotherapy 6. Prior malignancy within the previous 5 years 7. Severe mental disorders 8. Pregnant or lactating women 9. Other disease requiring simultaneous surgery or radiotherapy 10. Researchers believe that the situation is unsuitable for participation in the group
References
Publications (0)
Data not yet available