CTV Delineation Based Solely on Geometric Expansion From GTV in Nasopharyngeal Carcinoma: A Prospective, Multi-center, Randomized Controlled Phase III Clinical Study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 474
- 试验地点
- 1
- 主要终点
- Local failure-free survival (LFFS)
研究概览
简要总结
This is a randomized, phase III, prospective, multi-center trial in newly diagnosed nasopharyngeal carcinoma (NPC) patients without distant metastasis. The aim of this study is to evaluate the efficacy and safety of modified IMRT, of which CTV delineation was only based on geometric expansion from GTV.
详细描述
All enrolled patients underwent intensity-modulated radiation therapy (IMRT). The IMRT technique was selected based on the equipment available at each treatment center and the patients' preferences, including IMRT, VMAT, or TOMOTHERAPY. According to our study design, all enrolled patients will be randomly assigned in a 1:1 ratio before radiation therapy. The target area definitions are based on the international ICRU reports No. 50 and No. 60. The specific target area definitions and prescribed doses for the two groups are as follows:
- GTVp (70Gy/33Fx) Experimental Group: Gross tumor as seen on imaging and nasopharyngoscopy; Control Group: Gross tumor as seen on imaging and nasopharyngoscopy.
- CTVp1 (60Gy/33Fx) Experimental Group: None; Control Group: GTVp + 5 mm + entire nasopharyngeal mucosa.
- CTVp2 (54Gy/33Fx) Experimental Group: GTVp + 10 mm + entire nasopharyngeal mucosa; Control Group: GTVp + 10 mm + high-risk anatomical structures.
- GTVn Experimental Group: Lymph nodes as seen on imaging; Control Group: Lymph nodes as seen on imaging.
- CTVn Experimental Group: Defined according to CACA/CMDA guidelines; Control Group: Defined according to CACA/CMDA guidelines.
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
- •Pathologic diagnosis (pathologically confirmed by nasopharyngeal biopsy) was nasopharyngeal carcinoma;
- •No distant metastatic;
- •Patients with baseline MRI date of nasopharynx and neck, and completed the first course of treatment in our hospital;
- •Eastern Cooperative Oncology Group (ECOG) score of 0 or 1;
- •Signing informed consent;
- •Follow up regularly and comply with test requirements.
排除标准
- •Disease progression during IMRT;
- •Previous malignancy or other concomitant malignant diseases;
- •The evaluation information of tumor efficacy can not be obtained;
- •Receive blind treatment in other clinical research;
- •Have or are suffering from other malignant tumors within 5 years (except non- melanoma skin cancer or pre-invasive cervical cancer);
- •Serious complications, such as uncontrolled hypertension, coronary heart disease, diabetes, heart failure, etc;
- •Active systemic infection;
- •No or limited capacity for civil conduct;
- •The patient has a physical or mental disorder, and the researcher considers that the patient is unable to fully or fully understand the possible complications of this study;
- •Pregnancy or lactation period;
结局指标
主要结局
Local failure-free survival (LFFS)
时间窗: 3 years
The duration of time to LFFS was calculated from the date of histological diagnosis until documented treatment local failure or death from any cause.
次要结局
- overall survival(3 years)
- Regional failure-free survival(3 years)
- Distant metastasis-free survival(3 years)
- Patient's quality-of-life(3 years)