Radiotherapy Versus Elective Neck Dissection for Management of Cervical Nodes in Clinical T1/2N0 Supraglottic Squamous Cell Carcinoma
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 158
- Locations
- 1
- Primary Endpoint
- Neck control rates
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Outcomes
Primary Outcomes
Neck control rates
Time Frame: 2 years
The percentage of patients without cervical lymph node metastasis
Secondary Outcomes
- Treatment cost(4 weeks)
- Overall survival(5 years)
- Quality of life (EORTC QLQ-C30)(1 year)
- Disease-free survival(5 years)
- Quality of life (EORTC QLQ-HN35)(1 year)