A Randomized Controlled Trial of Plasma Radiofrequency Ablation at Low Temperature Versus Electrocautery Block Resection at High Frequency for Localized Recurrent Nasopharyngeal Carcinoma.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 3
- 主要终点
- Progression-free survival
研究概览
简要总结
This study aims at exploring whether plasma radiofrequency ablation at low temperature is associated with better survival outcome in localized recurrent nasopharyngeal carcinoma by conducting a randomized controlled trial of plasma radiofrequency ablation at low temperature versus electrocautery block resection at high frequency for localized recurrent nasopharyngeal carcinoma. If the hypothesis is confirmed, it is expected to provide a convenient choice for the surgical treatment of localized recurrent nasopharyngeal carcinoma.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 6 months disease free interval (defined as duration between the initial course of radiotherapy and recurrence)
- •Histopathologically diagnosed with undifferentiated or differentiated, nonkeratinizing nasopharyngeal carcinoma.
- •Resectable recurrent nasopharyngeal carcinoma: rT1-3N0-3M0 A) The tumor is confined to the nasopharyngeal mucosa, or the surface of the parapharyngeal space, or the bottom wall of the sphenoid sinus, and is more than 0.5cm away from the internal carotid artery B) The cervical lymph node lesions do not infiltrate the cervical spine, brachial plexus, cervical muscles, and internal carotid artery.
- •Age: 18-70 years old.
- •Subjects must sign an informed consent form.
排除标准
- •Karnofsky score (KPS)≤
- •Has known Subjects with other malignant tumors.
- •Has seriously mental disease.
- •Uncontrolled clinically significant heart disease and Pulmonary dysfunction.
- •Pregnancy or breast feeding.
研究组 & 干预措施
Plasma radiofrequency ablation arm
Plasma radiofrequency ablation at low temperature for localized recurrent nasopharyngeal carcinoma
干预措施: Plasma radiofrequency ablation (Procedure)
Electrocautery block resection arm
Electrocautery block resection at high frequency for localized recurrent nasopharyngeal carcinoma
干预措施: Electrocautery block resection (Procedure)
结局指标
主要结局
Progression-free survival
时间窗: 2 years
Time from randomisation to the date of disease progression or death from any causes. whichever came first.
次要结局
- Incidence of surgery related complications(1 year)
- Overall survival(2 years)
- Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0)(1 year)
- Loco-regional relapse-free survival(2 years)
- Distant metastasis-free survival(2 years)
- Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35)(1 year)
研究者
Ming-Yuan Chen
Chief physician, Proffessor
Sun Yat-sen University