Reduced Volume of Neck Prophylactic Irradiation in Nasopharyngeal Carcinoma: a Multi-center, Non-inferiority, Open-label, Randomized Controlled Phase III Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 474
- 试验地点
- 7
- 主要终点
- Regional recurrence-free survival
研究概览
简要总结
This is a multi-center, non-inferiority, open-label, randomized controlled phase III clinical trial in primary diagnosed nasopharyngeal carcinoma (NPC) patients without distant metastasis. The purpose of this study is to evaluate the efficacy of reduced neck prophylactic radiotherapy versus conventional neck prophylactic radiotherapy, and compare the radiotherapy-related adverse events and quality of life in two groups.
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
- •Newly histologic diagnosis of nasopharyngeal non-keratinizing carcinoma (WHO II/III);
- •All genders, range from 18-70 years old;
- •ECOG score 0-1;
- •Clinical stage I-IVa (AJCC/UICC 8th);
- •Not received radiotherapy, chemotherapy and other anti-tumor treatment (including immunotherapy);
- •No contraindications to chemotherapy or radiotherapy;
- •Adequate organ function: white blood cell count ≥ 4×109/L, neutrophile granulocyte count ≥ 1.5×109/L, hemoglobin ≥ 9g/L, platelet count ≥ 100×109/L; alanine aminotransferase or aspartate aminotransferase < 2.5×upper limit of normal; blood urea nitrogen or creatinine ≤ 1.5×upper limit of normal or endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula);
- •Sign the consent form.
排除标准
- •Neck lymph nodes exist skipping metastasis;
- •Distant metastases;
- •Keratinized squamous cell carcinoma or basal cell like squamous cell carcinoma;
- •Have or are suffering from other malignant tumors;
- •Participating in other clinical trials;
- •Pregnancy or lactation;
- •Have uncontrolled cardiovascular disease;
- •Severe complication, eg, uncontrolled hypertension;
- •Mental disorder;
- •Drug or alcohol addition;
- •Do not have full capacity for civil acts.
研究组 & 干预措施
Reduced CTVn2
Patients will receive the reduced neck prophylactic irradiation, only the level of positive lymph nodes and its next level.
干预措施: Intensity Modulated Radiation Therapy (Radiation)
Reduced CTVn2
Patients will receive the reduced neck prophylactic irradiation, only the level of positive lymph nodes and its next level.
干预措施: Chemotherapy (Drug)
Conventional CTVn2
Patients will receive the conventional neck prophylactic irradiation, as suggested by the international guideline.
干预措施: Intensity Modulated Radiation Therapy (Radiation)
Conventional CTVn2
Patients will receive the conventional neck prophylactic irradiation, as suggested by the international guideline.
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Regional recurrence-free survival
时间窗: 3 years
From the date of randomization to regional recurrence or any death
次要结局
- Progression free survival(3 years)
- Acute toxicities(From the start of treatment until 3 months post treatment)
- Late toxicities(3 years post treatment)
- Local recurrence-free survival(3 years)
- Overall survival(3 years)
- Distant metastasis-free survival(3 years)
- Quality of life score(During treatment and 3 years post treatment)
研究者
Zhao Chong
Doctor, Professor
Sun Yat-sen University