Maintenance Capecitabine Plus Best Supportive Care Versus Best Supportive Care for Metastatic Nasopharyngeal Carcinoma: a Multicenter, Randomised, Phase 3 Study.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- progression-free survival
研究概览
简要总结
This multicenter, randomised, phase 3 study is to evaluate the survival benefit of maintenance capecitabine plus best supportive care versus best supportive care for metastatic nasopharyngeal carcinoma patients after disease controlled with TPC palliative chemotherapy.
详细描述
Firstly diagnosed metastatic nasopharyngeal carcinoma patients will receive 4-6 cycles of palliative chemotherapy with taxol,cisplatin and capecitabine. After disease controlled, they will be randomly assigned to maintenance capecitabine plus best supportive care(BSC) or BSC alone. The primary end point is progression-free survival, the secondary end points are overall survival, duration of response, objective response rate, adverse effects and quality of life.
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
- •Firstly diagnosed metastatic nasopharyngeal carcinoma patients
- •Disease controlled after 4-6 cycles of palliative chemotherapy with taxol,cisplatin and capecitabine
- •Eastern Cooperative Oncology Group (ECOG) 0-2
- •Life expectation at least 12 weeks
- •No systemic chemotherapy within 6 months, except for induction chemotherapy or concurrent chemotherapy
- •With at least one measurable lesion
- •Enough blood test
- •Signed informed consent
排除标准
- •Sever heart disease
- •HIV infection
- •Sever infection
- •Brain metastasis, except received radical therapy 6 months ago and stable in 4 weeks
- •Allogeneic organ transplantation
- •Malignancy other than nasopharyngeal carcinoma, except:cervical carcinoma in situ, cured basal cell carcinoma,bladder cancer of Ta,Tis or T1, or any cured cancer for at least 3 years
- •Pregnancy or breast feeding
- •Difficulty in swallowing
- •Received other test drugs
研究组 & 干预措施
maintenance capecitabine
maintenance capecitabine plus best supportive care(BSC)
干预措施: capecitabine (Drug)
maintenance capecitabine
maintenance capecitabine plus best supportive care(BSC)
干预措施: Best supportive care (BSC) (Other)
best supportive care
Best supportive care and following-up every 6-8 weeks
干预措施: Best supportive care (BSC) (Other)
结局指标
主要结局
progression-free survival
时间窗: up to 6 years
the time from randomization to the progression of disease
次要结局
- overall survival(up to 6 years)
- duration of response(up to 6 years)
- objective response rate(up to 6 years)
- adverse effects(up to 6 years)
- quality of life of the patients during the Maintenance Capecitabine and/or Best Supportive Care(up to 6 years)
研究者
XIANG YANQUN
MD,PhD
Sun Yat-sen University