Radiotherapy vs Neck Dissection for Clinical T1/2N0 Supraglottic Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Radiotherapy Versus Elective Neck Dissection for Management of Cervical Nodes in Clinical T1/2N0 Supraglottic Squamous Cell Carcinoma

Conditions
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Supraglottic Cancer

Intervention / Treatment
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* Radiation: Radiotherapy
* Procedure: Selective neck dissection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to understand and the willingness to sign a written informed consent document Age≥ 18 and≤ 75 years Histological/ cytological/ Imaging examination proven supraglottic squamous-cell carcinoma in preoperative assessment Cervical node negative according to the imaging characteristics and the physical examination KPS≥ 70 Normal bone marrow reserve function and normal liver, kidney function Expected survival period≥ 12 months Exclusion Criteria: Inability to provide an informed consent Proved distant metastasis Clinical stage 3-4 The patient has received prior surgery or radiotherapy (except for biopsy ) The patient has received chemotherapy(including targeted therapies) or immunotherapy Prior malignancy within the previous 5 years Severe mental disorders Pregnant or lactating women Other disease requiring simultaneous surgery or radiotherapy Researchers believe that the situation is unsuitable for participation in the group

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiotherapy<br>Radiotherapy & open partial supraglottic laryngectomy(primary tumor) | Radiation: Radiotherapy<br>* Radiotherapy with a dose of 66-70 Gy is used to manage the cervical lymph nodes<br>|
| Active Comparator: Elective neck dissection<br>Elective neck dissection & open partial supraglottic laryngectomy(primary tumor) | Procedure: Selective neck dissection<br>* Selective neck dissection, defined as surgical clearance of the upper jugular (leveI II), midjugular (level III) and sometimes submandibular (level I) nodes, is used to manage the cervical lymph nodes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neck control rates | The percentage of patients without cervical lymph node metastasis | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival | The proportion of patients did not find clear evidence of recurrence or metastasis | 1 year | 
| Disease-free survival | The proportion of patients did not find clear evidence of recurrence or metastasis | 2 years | 
| Disease-free survival | The proportion of patients did not find clear evidence of recurrence or metastasis | 3 years | 
| Disease-free survival | The proportion of patients did not find clear evidence of recurrence or metastasis | 5 years | 
| Overall survival | The proportion of patients who survived | 3 years | 
| Overall survival | The proportion of patients who survived | 5 years | 
| Quality of life (EORTC QLQ-C30) | Evaluated by the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 | 1 year | 
| Quality of life (EORTC QLQ-HN35) | Evaluated by the European Organization for Research and Treatment of Cancer (EORTC) QLQ-HN35 | 1 year | 
| Treatment cost | The total cost of the treatment of the primary and cervical lymph nodes until the discharge | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Supraglottic cancer, Laryngeal cancer, Cervical lymph node, Neck dissection