NCT01836120Unknown2 期
A Study of Raltitrexed Plus Docetaxel Versus Docetaxel as Second-line Chemotherapy in Subjects With 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: 2013年4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
A study of Raltitrexed plus Docetaxel versus Docetaxel as second-line chemotherapy in subjects with Gastric Cancer.The purpose of this study is to compare the activity of Raltitrexed plus Docetaxel versus Docetaxel as second-line chemotherapy in subjects with gastric carcinoma by estimating progression free survival (PFS) in each treatment arm.
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
- Double (Participant, Investigator)
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) 0-2;
- •Histologically or cytologically confirmed gastric cancer;
- •The first-line chemotherapy failure (required containing 5-fluorouracil)
- •At least have one measurable disease(according to RECIST, Response Evaluation Criteria in Solid Tumors )
- •Life expectancy of at least 3 months;
排除标准
- •Received any prior treatment including Raltitrexed;
- •Active or uncontrolled infection;
- •Concurrent treatment with an investigational agent or participation in another therapeutic clinical trial;
- •Pregnant or lactating women.
研究组 & 干预措施
Raltitrexed plus Docetaxel
Experimental
干预措施: Raltitrexed plus Docetaxel (Drug)
Docetaxel
Active Comparator
干预措施: Docetaxel (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)
- Overall Survival (OS)(1 year)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Docetaxel, Trabectedin, and G-CSF or Pegfilgrastim in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Primary Peritoneal Cavity Cancer, or Fallopian Tube CancerFallopian Tube CancerPrimary Peritoneal Cavity CancerOvarian CancerNCT00569673Gynecologic Oncology Group71
已完成
2 期
Influence of Prior Chemotherapy on Clinical Benefit With Erlotinib in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer With or Without EGFR Gene MutationAdvanced Non-Squamous Non-Small Cell Lung CancerNCT01204307Chang Gung Memorial Hospital101
终止
2 期
Docetaxel and Cisplatin in Treating Patients With Stage III or Stage IV Non-Small Cell Lung CancerLung CancerNCT00118131University of Medicine and Dentistry of New Jersey49
已完成
2 期
Docetaxel and Cisplatin in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer That Has Been Completely Removed By SurgeryLung CancerNCT00281970Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins50
Unknown
1 期
Docetaxel and Oxaliplatin in Treating Patients With Stage III or Stage IV Ovarian Epithelial CancerOvarian CancerNCT00075543GERCOR - Multidisciplinary Oncology Cooperative Group