Supraglottic Cancer
Conditions
Keywords
Supraglottic cancer, Laryngeal cancer, Cervical lymph node, Neck dissection
Brief summary
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.
Interventions
RADIATIONRadiotherapy
Radiotherapy with a dose of 66-70 Gy is used to manage the cervical lymph nodes
PROCEDURESelective neck dissection
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
Sponsors
Tianjin Medical University General Hospital
Tianjin Medical University Second Hospital
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neck control rates | 2 years | The percentage of patients without cervical lymph node metastasis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free survival | 1 year | The proportion of patients did not find clear evidence of recurrence or metastasis |
| Overall survival | 3 years | The proportion of patients who survived |
| Quality of life (EORTC QLQ-C30) | 1 year | Evaluated by the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 |
| Quality of life (EORTC QLQ-HN35) | 1 year | Evaluated by the European Organization for Research and Treatment of Cancer (EORTC) QLQ-HN35 |
| Treatment cost | 4 weeks | The total cost of the treatment of the primary and cervical lymph nodes until the discharge |
Countries
China
Contacts
Primary ContactDong Xu Wang, Ph.D
Backup ContactZe Zhang, MD
Outcome results
None listed