Adjuvant Chemotherapy or Not for NPC Patients Staged N2-3M0 After Concurrent Chemotherapy :a Phase Ⅱ Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- treatment toxicity based on a CTCAE3.0 grading system
研究概览
简要总结
By this clinical trial, the investigators are trying to give an answer to such a question. Whether NPC patients staged N2-3M0 need adjuvant chemotherapy consisting of paclitaxel and platinum after concurrent chemoradiation?
详细描述
Recent research (Lancet Oncology 2012)shows that no survival benefits were achieved by adding adjuvant chemotherapy after concurrent chemoradiation in patients with locoregionally advanced NPC. But in patients with even high risk of distant metastasis(staged N2-3M0),is adjuvant chemotherapy necessary?
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pathologically confirmed untreated NPC patients staged N2-3M0
- •age: 18y - 65y
- •with MRI examinations
- •with written consent
排除标准
- •without a second cancer
- •with other severe diseases(blood,liver ,kidney or heart diseases)
- •could not staged properly
- •without written consent
研究组 & 干预措施
Adjuvant chemotherapy with paclitaxel and nedaplatin
Patients will receive 3 cycles of adjuvant chemotherapy consisting of paclitaxel and platinum after concurrent chemoradiation
干预措施: Adjuvant chemotherapy with paclitaxel and nedaplatin (Drug)
结局指标
主要结局
treatment toxicity based on a CTCAE3.0 grading system
时间窗: 6 months
次要结局
- progress free survival(24 months)
研究者
Dr. Xia He
Director of the department of radiotherapy
Jiangsu Cancer Institute & Hospital