NCT00919282已完成2 期
A Multi Center Phase II Study of 5-Fluorouracil/ Folinic Acid Plus Gemcitabine in Patients With Advanced Pancreatic Cancer.
CONKO-Studiengruppe1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 1997年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- overall survival
研究概览
简要总结
The purpose of this study is to examine the efficacy and safety of the drug combination GFF in patients with advanced pancreatic cancer (APC).
详细描述
This open-label, multi center phase II study was conducted to investigate the efficacy and safety of the combination of 5-Fluorouracil (5-FU)/folinic acid (FA) plus gemcitabine (GFF) in patients (pts) with advanced pancreatic cancer (APC). We consequently started this study after completing the phase I trial accomplished by our CONKO- study group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •histological proved pancreatic cancer
- •inoperable disease
- •informed consent
- •adequate bone marrow reserve
排除标准
- •under 18 years
- •brain metastasis
- •lactating woman
- •life expectancy under 3 months
研究组 & 干预措施
Gemcitabine/folinic acid/5-FU
Experimental
Gemcitabine 1g/m² 5-FU 750mg/m² FS 500 mg/m²
干预措施: gemcitabine, folinic acid, 5-FU (Drug)
结局指标
主要结局
overall survival
时间窗: 1 year
次要结局
- safety of treatment(1 year)
研究者
研究点 (1)
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