NCT07268690尚未招募3 期
Risk-Adapted Omission of Level Va Irradiation in Nasopharyngeal Carcinoma: A Phase III Randomized Non-Inferiority Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 474
- 试验地点
- 1
- 主要终点
- Regional failure-free survival
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. This study will evaluate whether omitting Level Va irradiation in patients without these risk features does not compromise regional control or survival, with the goal of providing robust evidence to guide further personalization of NPC radiotherapy.
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;
- •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
- •Ipsilateral Level IIb involvement;
- •Ipsilateral Level III nodes involvement;
- •Ipsilateral positive lymph nodes below the cricoid cartilage (Level IV or Vb-c);
- •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)
- Patient's quality-of-life(3 years)
- Distant metastasis-free survival(3 years)
- Local failure-free survival(3 years)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Velopharyngeal Dysfunction in Head & Neck Cancer Patients, Pilot StudySpeech DisorderNCT07264036Vanessa Torrecillas20
尚未招募
3 期
Elective Level Ib Irradiation in Nasopharyngeal Carcinoma Patients Based on the International GuidelinesNasopharyngeal CarcinomaNCT05519956Fujian Cancer Hospital398
尚未招募
不适用
A study of 254nm UVC ray therapy in pharynx for asymptomatic to mild cases of Corona Virus DiseaseCTRI/2020/06/025766Dr Jagdeep Kakadia
Unknown
2 期
Early and Whole Course Nutritional Support by Nutren® Optimum During IMRT for Nasopharyngeal CarcinomaNutritional SupportNasopharyngeal CarcinomaNCT03344068Sun Yat-sen University408
招募中
不适用
De-escalated Radiotherapy for Primary Tumor After Neoadjuvant Therapy With Toripalimab Plus Chemotherapy for Nasopharyngeal CarcinomaComplications RadiotherapyIMMUNOTHERAPYNasopharyngeal CarcinomaNCT06313450Sun Yat-sen University112