Phase 3, Prospective, Randomized, Open-Label Study on Simultaneously Reducing Both the Dose and the Irradiated Volume of Cervical Prophylactic Irradiation in Nasopharyngeal Cancer
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 474
- 主要终点
- Regional failure-free survival
研究概览
简要总结
The purpose of this study is to investigate whether reducing both the dose and the irradiated volume of cervical prophylactic irradiation in patients with nasopharyngeal cancer can maintain efficacy while decreasing toxicity. This will be achieved through a comparison of standard cervical prophylactic irradiation with a reduced-dose and reduced-volume approach.
详细描述
Patients with non-metastatic nasopharyngeal cancer who are candidates for receiving definitive IMRT are randomly assigned to receive either standard cervical prophylactic irradiation or a reduced-dose and reduced-volume approach. The standard arm receives the conventional dose and volume of irradiation, while the experimental arm receives a lower dose and a smaller irradiated volume. Both groups will undergo intensity-modulated radiotherapy (IMRT) to the primary tumor and involved lymph nodes. The primary endpoint of this study is regional-control (RC), and secondary endpoints include overall survival (OS), local control (LC), distant metastasis-free survival (DMFS), and toxicity. All efficacy analyses will be conducted in the intention-to-treat population, and the safety population will include only patients who receive their randomly assigned treatment.
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
Regional failure-free survival
时间窗: 3 years
The regional relapse-free survival rate will be estimated using Kaplan-Meier method for each arm from the date of randomization to the date of nodal relapse or death from any cause, whichever occurred first. Their differences will be compared between treatment arms using the log-rank test.
次要结局
- Overall Survival(3 years)
- Number of participants with adverse events(3 years)
- Incidence of acute and late toxicity(3 years)
- Local failure-free survival (LFFS)(3 years)
- Distant metastasis-free survival(3 years)