Study on Delineation of the Target Volumes and Determination of the Irradiation Doses in Untreated Nasopharyngeal Carcinoma (NPC) Treated With Intensity Modulated Radiation Therapy (IMRT)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- 5-year loco-regional recurrence free survival (LRRFS)
研究概览
简要总结
The gross tumor volumes of the primary site and the neck nodes (GTVnx and GTVnd) could be delineated according to the post-NACT tumor position and receive radical radiation dose, while the tumor disappear after NACT could be encompassed in the first clinical target volume (CTV1) and receive high preventive radiation dose. Through this method,it is more likely to achieve the ultimate goal that maximize the chance of cure while minimize the injury of surrounding normal tissues, maintaining organ function and life quality. Therefore, this stage II clinical trial was designed to study the prognosis and locoregional failure patterns of this target volume delineation method in LA-NPC treated with NACT plus CCRT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically confirmed NPC;
- •no evidence of distant metastasis;
- •no previous treatment for NPC;
- •stages III-IVb disease according to the staging system of the 6th AJCC/UICC;
- •adequate liver, renal and bone marrow function;
- •Karnofsky Performance Status (KPS) ≥80 scores.
排除标准
- •fine-needle aspiration biopsy, incisional or excisional biopsy of neck lymph node, or neck dissection prior NACT;
- •disease progression during NACT;
- •presence of distant metastasis;
- •pregnancy or lactation;
- •previous malignancy or other concomitant malignant disease.
研究组 & 干预措施
Target volume delineation after NACT
干预措施: Target Volume Delineation after NACT (Radiation)
结局指标
主要结局
5-year loco-regional recurrence free survival (LRRFS)
时间窗: Five years
次要结局
- 5-year overall survival (OS)(Five years)
- 5-year regional recurrence free survival (RRFS)(Five years)
- Locoregional failure patterns(Five years)
- 5-year local recurrence free survival (LRFS)(Five years)
- 5-year disease specific survival (DSS)(Five years)
- Late toxicities(Five years)
- 5-year distant metastasis free survival (DMFS)(Five years)
研究者
Zhao Chong
MD
Sun Yat-sen University