A Phase III Randomized Trial of Maintenance Chemotherapy in High-metastatic Risk Nasopharyngeal Carcinoma Patients of N3 Stage
试验速览
- 阶段
- 3 期
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Distant metastatic free survival
研究概览
简要总结
Up to now, IMRT has largely improved the local control of locally advanced nasopharyngeal carcinoma (NPC), leaves the distant metastasis as the main treatment failure modality of patients with bulky lymph nodes (especially N3 stage). Although concurrent chemoradiotherapy (CCRT) continues to stand as the standard treatment of these patients, the role of adjuvant chemotherapy remains controversial due to its relatively severe toxicities and inferior compliance. However, our retrospective study of 2D-RT and IMRT era had proved adjuvant chemotherapy played key role in N3 NPC patients in terms of reducing distant metastasis and improving overall survival. Maintenance chemotherapy of gemicitabine single drug is promising with adequate efficacy and moderate toxicities. So we aim to conduct "A Phase III Randomized Trial of Maintenance Chemotherapy in High-metastatic Risk Nasopharyngeal Carcinoma Patients of N3 Stage" to evaluate the effectiveness and compliance of gemicitabine as maintenance chemotherapy in N3 nasopharyngeal carcinoma.
详细描述
We aim to conduct "A Phase III Randomized Trial of Maintenance Chemotherapy in High-metastatic Risk Nasopharyngeal Carcinoma Patients of N3 Stage" to evaluate the effectiveness and compliance of gemicitabine as maintenance chemotherapy in N3 nasopharyngeal carcinoma.
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 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AJCC/UICC 8th edition N3 nasopharyngeal carcinoma
- •Pathology: WHO II/II
- •No prior anti-tumor treatment
- •Age 18-60
- •Adequate blood supply
- •Informed consent obtained
排除标准
- •Pathology: WHO I
- •Combined with other malignant tumor
研究组 & 干预措施
maintenance arm
Gemcitabine maintenance treatment
干预措施: Gemcitabine (Drug)
maintenance arm
Gemcitabine maintenance treatment
干预措施: standard chemoradiotherapy (Radiation)
control arm
observe and follow-up
干预措施: standard chemoradiotherapy (Radiation)
结局指标
主要结局
Distant metastatic free survival
时间窗: 5 year
from enrollment to distant metastatis
次要结局
未报告次要终点
