De-escalation of Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- DFS
研究概览
简要总结
The purpose of this study is to explore the efficacy and safety of image guided de-escalation protocols in patients with locoregionally advanced nasopharyngeal carcinoma (NPC). So the investigators studied whether toxicities reducing treatment with omitted concurrent chemotherapy after good response to induction chemotherapy would maintain survival outcomes while improving tolerability for patients with locoregionally advanced nasopharyngeal carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Histological diagnosis of nasopharyngeal carcinoma
- •Stage III or IVA according to UICC/AJCC 8th staging system
- •No prior anti-tumor treatment
- •Karnofsky Performance Score (KPS)≥70
- •Adequate blood supply
- •Informed consent obtained
排除标准
- •Can not take contrast-MRI imaging
- •Combined with other malignant tumor (except basal cell carcinoma of skin)
研究组 & 干预措施
Toxicities reduced treatment
Patients receive docetaxel(75mg/m2 d1) and cisplatin(25 mg/m2 d1-3) every 3 weeks for 3 cycles as induction chemotherapy, followed by omitting concurrent cisplatin chemotherapy when responses to induction chemotherapy are ≥ 50% Partial Response(PR).
干预措施: Toxicities reduced treatment (Radiation)
Conventional treatment
Patients receive docetaxel(75mg/m2 d1) and cisplatin(25 mg/m2 d1-3) every 3 weeks for 3 cycles as induction chemotherapy, followed by concurrent cisplatin chemotherapy with standard radiation dose when responses to induction chemotherapy are less than 50% Partial Response(PR).
干预措施: Conventional treatment (Radiation)
结局指标
主要结局
DFS
时间窗: 3 year
Disease Free Survival
次要结局
- OS(3 year)
研究者
Chaosu Hu
Principal Investigator
Fudan University