Radiotherapy Versus Elective Neck Dissection for Management of Cervical Nodes in Clinical T1/2N0 Supraglottic Squamous Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- Neck control rates
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Radiotherapy
Radiotherapy & open partial supraglottic laryngectomy(primary tumor)
干预措施: Radiotherapy (Radiation)
Elective neck dissection
Elective neck dissection & open partial supraglottic laryngectomy(primary tumor)
干预措施: Selective neck dissection (Procedure)
结局指标
主要结局
Neck control rates
时间窗: 2 years
The percentage of patients without cervical lymph node metastasis
次要结局
- 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)
- Disease-free survival(1 year)
- Disease-free survival(2 years)
- Disease-free survival(3 years)
- Overall survival(3 years)