NCT01468389Unknown3 期
A Randomized Multicenter Phase III Study:Taxanes or Platinum in Combination With Capecitabine Followed by Capecitabine Alone vs.Taxanes or Platinum Combined With Capecitabine in Advanced Adenocarcinoma of the Stomach or Esophagogastric Junction.
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2011年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Progression free survival
研究概览
简要总结
The purpose of this study is to investigate whether Taxanes or Platinum Plus Capecitabine With Capecitabine Maintenance Treatment as 1st line treatment in he advanced gastric cancer is effective and safe.
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
- •Having signed informed consent
- •Age≥ 18 years old
- •Histologically confirmed gastric adenocarcinoma
- •Unresectable recurrent or metastatic disease
- •Previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 6 months
- •Previous chemotherapy with oxaliplatin or cisplatin or paclitaxel or docetaxel, if applicable, more than 12 months.
- •Measurable disease according to the RECIST criteria
- •ECOG performance status ≤2
- •Life expectancy of ≥3 month
- •No prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks
- •ALT and AST≤2.5 times ULN (≤5 times ULN in patients with liver metastases) Serum albumin level ≥3.0g/dL Serum creatinine ≤1.5ULN Bilirubin level ≤ 1.5 ULN WBC>3,000/mm3, absolute neutrophil count ≥1500/mm3, platelet>90,000/mm3, Hb>8g/dl
排除标准
- •Brain metastasis (known or suspected)
- •Previous systemic therapy for metastatic gastric cancer
- •Inability to take oral medication
- •Previous therapy targeting at angiogenesis or vasculogenesis pathway or other targeted therapy
- •Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry
- •Allergic constitution or allergic history to any investigating agents.
- •Severe heart disease or such history as recorded congestive heart failure, uncontrolled cardiac arrhythmia, angina pectoris needing medication, cardiac valve disease, severe abnormal ECG findings, cardiac infarction , or retractable hypertension.
- •Pregnancy or lactation period
- •Any investigational agent within the past 28 days
- •Other previous malignancy within 5 year
- •Pre-existing neuropathy>grade 1
- •Legal incapacity
研究组 & 干预措施
Taxanes or Platinum in combination with Capecitabine
Active Comparator
The patients will received chemotherapy combining capecitabine with platinum or taxanes until progression.
干预措施: capecitabine (Drug)
chemotherapy followed by capecitabine alone
Experimental
The patients who has received 4 cycle chemotherapy combining capecitabine with platinum or taxanes and the result was SD or CR or PR,will be given capecitabine alone until progression.
干预措施: capecitabine (Drug)
结局指标
主要结局
Progression free survival
时间窗: 1 year
次要结局
- Tumor response rate(1 year)
- disease control rate(1 year)
- overall survival(3 year)
- adverse events(3 year)
研究者
Xu jianming
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
研究点 (1)
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