NCT01015339Unknown3 期
A Randomized Multicenter Phase III Study Comparing Paclitaxel Plus Capecitabine With Capecitabine Maintenance Treatment or Cisplatin Plus Capecitabine in Metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction
Peking University1 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2009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
- 320
- 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 Paclitaxel 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 —（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 capecitabine or cisplatin, if applicable, more than 12 months.
- •Measurable disease according to the RECIST criteria
- •Karnofsky performance status ≥60
- •Life expectancy of ≥2 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 AKP < 2.5 times ULN
- •Serum creatinine <ULN, and CCr < 60ml/min
- •Bilirubin level < 1.5 ULN
- •WBC>3,000/mm3, absolute neutrophil count ≥2000/mm3, platelet>100,000/mm3, Hb>9g/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
- •Contraindications of nuclear magnetic resonance image such as fitment of cardiac pacemaker , nerve stimulator, or aneurysm clip, and metallic foreign body in eye ball and so on.
- •Allergic constitution or allergic history to protium biologic product or 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, except non-melanoma skin cancer
- •Previous adjuvant therapy with capecitabine+platinum,
- •Pre-existing neuropathy>grade 1
- •Legal incapacity
研究组 & 干预措施
Cisplatin plus capecitabine
Active Comparator
干预措施: capecitabine (Drug)
Cisplatin plus capecitabine
Active Comparator
干预措施: cisplatin (Drug)
Paclitaxel plus Capecitabine
Experimental
干预措施: Paclitaxel (Drug)
Paclitaxel plus Capecitabine
Experimental
干预措施: capecitabine (Drug)
结局指标
主要结局
Progression free survival
时间窗: 3 year
次要结局
- Disease control rate(1 year)
- Overall survival(5 year)
- Tumor response rate(1 year)
- adverse evens(5 year)
研究者
Shen Lin
M.D.
Peking University
研究点 (1)
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