Endoscopic NBI Combined With MRI to Guide the Optimization of Clinical Target Volume Delineation in Eccentric Nasopharyngeal Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Acute adverse reactions
研究概览
简要总结
This is a prospective, single-center clinical trial in eccentric nasopharyngeal carcinoma (NPC) patients. The aim of this study is to evaluate the efficacy and safety of NBI combined with MRI-guided optimized CTV compared with conventional CTV, and to compare the radiotherapy-related adverse events and quality of life between the two groups.
详细描述
All patients with eccentric nasopharyngeal carcinoma were selected on the basis of MRI findings and NBI endoscopy was performed in these patients. The patients were enrolled if both NBI endoscopy and MRI showed eccentric NPC. Patients with contralateral tissue mucosal abnormalities detected by NBI and confirmed by biopsy were excluded. Then the patients were randomly divided into an experimental group (Optimized CTV) or a control group (Conventional CTV) to evaluate the efficacy and safety of the two groups, as well as radiotherapy-related adverse events.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females ≥18 years of age;
- •ECOG Performance Status 0,1 or 2;
- •Pathologically diagnosed as nasopharyngeal carcinoma;
- •Pretreatment nasopharynx and neck MRI imaging;
- •Nasopharyngeal suspected lesions were examined by NBI endoscopy;
- •Meeting the definition of eccentric NPC with ipsilateral (affected side) staging of T1-4 and contralateral (healthy side) staging of T0;
- •Patients evaluated without contraindications to radiotherapy;
- •Voluntary participation in clinical research, and signed informed consent.
排除标准
- •Patients who did not successfully undergo all three examinations (MRI, NBI, and endoscopic biopsy);
- •Other rare pathological types, such as adenocarcinoma;
- •Patients with tumor invasion of the clivus;
- •Patients whose contralateral retropharyngeal lymph nodes met the diagnostic criteria;
- •Invasion of paranasal sinuses (except simple sphenoid invasion).
结局指标
主要结局
Acute adverse reactions
时间窗: 3 months
The acute adverse reactions of patients during or after radiotherapy were evaluated with the corresponding standard scales.
Control rate of non-irradiated area
时间窗: 36 months
次要结局
- Progress-free survival(PFS)(36 months)
- Local recurrence-free survival(LRFS)(36 months)
- Overall survival (OS)(36 months)
研究者
Ying Wang
Associate Director of Chongqing University Cancer Hospital
Chongqing University Cancer Hospital