Phase II Study of SOX in Patients With Platinum-resistant Nasopharyngeal Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Median progression-free survival
研究概览
简要总结
The aim of the study is to evaluate the efficacy and safety of SOX regimen (S-1 plus oxaliplatin) as salvage treatment in patients with relapsed or metastatic nasopharyngeal carcinoma.
详细描述
The treatment option in patients with platinum-resistant relapsed or metastatic nasopharyngeal carcinoma is limited. Previous studies showed that both S-1 and oxaliplatin were effective in head and neck cancer. Moreover, SOX (S-1 plus oxaliplatin) was proved to be tolerable in advanced stage gastric cancer. Therefore, we aim to evaluate this regimen in salvage setting of nasopharyngeal carcinoma.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range: 18-75 years old
- •Histological confirmed incurable relapsed or metastatic nasopharyngeal carcinoma
- •Prior exposure of at least one line of platinum-containing regimen
- •ECOG performance status 0-1
- •Life expectancy of more than 3 months
- •Bone marrow function: ANC≧1.5×109/L, PLT≧100×109/L, Hb≧80g/L
- •Liver function: total bilirubin, ALT and AST <1.5×UNL
- •Renal function: Cr<1.5×UNL, CCR≧50ml/min
- •Without > 1 grade of neuropathy
排除标准
- •With curable treatment option
- •With CNS involvement
- •Prior platinum exposure only in neo-adjuvant/adjuvant setting or concurrently used with radiotherapy
- •Treated with > 2 lines of palliative chemotherapy
- •With prior exposure of S-1 or oxaliplatin
- •History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- •Significant active infection
- •Pregnant or lactating women
研究组 & 干预措施
S-1 plus oxaliplatin
S-1 60 mg BID at day 1-14 Oxaliplatin 100 mg/m2 at day 1 Frequence of cycles: every 3 weeks for 6 cycles
干预措施: S-1 plus oxaliplatin (Drug)
结局指标
主要结局
Median progression-free survival
时间窗: 1 year
次要结局
- Overall response rate(6 weeks)
- Median overall survival(1.5 year)