Shrinking the Anterior Border of CTV2 for Nasopharyngeal Carcinoma to Reduce the Radiation of Nasal Cavity : an Open-label, Non-inferiority, Multicenter, Randomized Phase III Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 550
- 试验地点
- 5
- 主要终点
- Local relapse-free survival
研究概览
简要总结
This is a an open-label, non-inferiority, multicenter, randomized phase III trial aimed to explore the efficacy and safety of shrinking the anterior border of CTV2 in nasopharyngeal carcinoma patients without tumor invasion into the posterior nasal aperture.
详细描述
This is a an open-label, non-inferiority, multicenter, randomized phase III trial aimed to explore the efficacy and safety of shrinking the anterior border of CTV2 in nasopharyngeal carcinoma patients without tumor invasion into the posterior nasal aperture. The enrolled patients will be 1:1 randomly assigned to receive reduced CTV delineation radiotherapy (anterior border of CTV2 defined as 5 mm anterior to the choanae), or standard CTV delineation radiotherapy (anterior border of CTV2 defined as the posterior 1/3 of the nasal cavity).
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 diagnosed, histologically confirmed non-keratinizing carcinoma (WHO classification).
- •Stage I-III disease (AJCC 9th edition).
- •Tumor extends to nasal cavity (including nasal septum).
- •No distant metastasis (M0).
- •Age 18-70 years.
- •Male or non-pregnant female.
- •Scheduled for radiotherapy.
- •ECOG performance status 0-1 .
- •Adequate bone marrow function: white blood cells >4×10⁹/L, hemoglobin >90 g/L, platelets >100×10⁹/L.
- •Normal hepatic/renal function: total bilirubin ≤1.5×ULN, AST/ALT ≤2.5×ULN, alkaline phosphatase ≤2.5×ULN, creatinine clearance ≥60 mL/min.
- •Written informed consent obtained.
排除标准
- •Keratinizing squamous cell carcinoma (WHO Type I) or basaloid squamous cell carcinoma.
- •Age <18 or >70 years.
- •Recurrent disease or distant metastasis.
- •No tumor extension into the nasal cavity (including the nasal septum).
- •Prior malignancy (except adequately treated basal/squamous cell skin cancer or cervical carcinoma in situ).
- •Pregnancy/lactation (premenopausal women require pregnancy test; effective contraception mandated).
- •Prior radiotherapy (except non-melanoma skin cancer with lesions outside current portals).
- •Preoperative chemotherapy or surgical resection of primary/neck lesions (excluding diagnostic procedures).
- •Severe coexisting illness.
结局指标
主要结局
Local relapse-free survival
时间窗: 3 year
The time from randomization to documented local relapse or death from any cause.
次要结局
- Progression-free survival(3 year)
- Overall survival(3 year)
- Change of quality of life(1 year)
- Distant metastasis-free survival(3 year)
- Incidence rate of adverse events (AEs)(2 year)
- Regional relapse-free survival(3 year)
研究者
Hai-Qiang Mai,MD,PhD
Professor
Sun Yat-sen University