NCT01718626Unknown2 期
Study Comparing Sequential Therapy of S1+Docetaxel Followed by S1 to Concomitant S1+Docetaxel for Advanced Gastric Cancer
Hebei Tumor Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2012年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Progression-free survival(PFS)
研究概览
简要总结
Stage 1:First line therapy Sequential therapy of S1+Docetaxel followed by S1 is superior to concomitant S1+Docetaxel in the safety and clinical efficiency.
Stage 2:Second line therapy To explore the feasibility of single drug(S1) maintenance treatment for advanced gastric cancer.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent form
- •Performance Status-Eastern Cooperative Oncology Group (ECOG) 0-1
- •Histologically or cytologically confirmed gastric cancer
- •Advanced or recurrent, metastatic disease
- •At least have one measurable disease(according to RECIST, Response Evaluation Criteria in Solid Tumors )
- •Life expectancy of at least 3 months
- •Target target lesion has not received radiotherapy or non target lesion radiation at least 4 weeks
- •Haematopoietic and Hepatic status:
- •Absolute neutrophil count >1.5x109/L,Platelet count > 100 x 109/L,Hemoglobin at least 9 g/dl,Bilirubin ≤ 1.5 x upper limit of normal (ULN),AST and ALT ≤ 2.5 times ULN(no liver metastasis), ≤5 times ULN(with liver metastasis)
- •Cardiovascular: Baseline LVEF 50% measured by echocardiography
排除标准
- •Symptomatic brain metastasis
- •Active or uncontrolled infection
- •Unresolved or unstable, serious toxicity from prior cancer treatment (any toxicities greater than grade 2; peripheral neuropathy of grade 2 or greater Symptomatic brain metastasis
- •Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, uncontrolled hypertension (≥ 180/110), unstable diabetes mellitus, dyspnea at rest, or chronic therapy with oxygen
- •History of other malignancy
- •Pregnant or lactating women
研究组 & 干预措施
S1+Docetaxel
Active Comparator
干预措施: S1+Docetaxel (Drug)
S1+Docetaxel followed by S1
Experimental
干预措施: S1+Docetaxel followed by S1 (Drug)
结局指标
主要结局
Progression-free survival(PFS)
时间窗: 1 years
次要结局
- Objective response rate(ORR)(1 year)
- Disease control rate(DCR)(1 year)
- Overall survival(OS)(3 years)
研究者
研究点 (1)
Loading locations...
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