NCT00813696Unknown3 期
Gemcitabine vs Gemcitabine + Cisplatin in the Treatment of Advanced Pancreatic Cancer (Stage II III IV)
Istituti Tumori Giovanni Paolo II42 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2002年4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
- 400
- 试验地点
- 42
- 主要终点
- overall survival
研究概览
简要总结
The purpose of this study is to evaluate the impact of the addition of cisplatin to gemcitabine in the treatment of patients with inoperable advanced pancreatic 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
- •Histologic or cytologic diagnosis pancreatic cancer
- •inoperable stage II or stage III or IV disease(UICC, 1997)
- •Age 18 to 75 years
- •Karnofsky Performance status > 50
- •Signed informed consent
排除标准
- •Previous chemotherapy
- •Cerebral metastases
- •Previous malignancies in past 5 years excluding adequately treated basal or spinocellular skin cancers and insitu cervical cancer
- •Leukocytes < 4000 or neutrophils < 2000 or platelets < 100000 or hemoglobin < 10 g/dl
- •Creatinine value > upper normal limit
- •GOT or GPT > 2.5 times upper normal limit or bilirubin > 1.5 times upper normal limit in absence of hepatic metastases
- •Congestive heart failure, severe cardiac arrhythmias or coronary ischemic disease
- •Other concurrent disease that would, in the investigator's opinion, contraindicate the use of the study drugs
- •Inability to provide informed consent
- •Inability to comply with follow-up.
研究组 & 干预措施
A
Experimental
cisplatin + gemcitabine
干预措施: gemcitabine (Drug)
A
Experimental
cisplatin + gemcitabine
干预措施: cisplatin (Drug)
B
Active Comparator
gemcitabine
干预措施: gemcitabine (Drug)
结局指标
主要结局
overall survival
时间窗: 9 months
次要结局
- clinical benefit response(baseline and at end of every cycle of therapy)
- quality of life(baseline and at end of every cycle of therapy)
- objective response(after 7 weeks of therapy)
- time to progression(6 months)
研究者
研究点 (42)
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