EUCTR2013-002973-23-IT进行中（未招募）不适用
A Phase II randomized trial comparing a combination of Abraxane and Gemcitabine versus Gemcitabine alone as first line treatment in locally advanced unresectable pancreatic cancer. - Gemcitabine Abraxane Pancreas
Fondazione GISCAD0 个研究点开始时间: 2013年9月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Written informed consent
- •Age < 75 years
- •Histologically/cytologically confirmed locally advanced, unresectable pancreatic cancer
- •At least one lesion measurable with CT or MRI scan
- •Performance Status (ECOG) 0-1 at study entry
- •Life expectancy of at least 3 months
- •Adequate marrow, liver and renal function
- •Effective contraception if the risk of conception exists
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 124
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Previous chemotherapy or radiotherapy for pancreatic cancer
- •CNS metastases
- •Severe cardiovascular disease
- •Thrombotic or embolic events
- •Acute or subacute intestinal occlusion or history of inflammatory bowel disease
- •Known hypersensitivity to study drug
- •Known drugs or alcohol abuse
- •Pregnant or breastfeeding women
- •Previous or concurrent malignancy; except for basal or squamous cell skin cancer and/or in situ carcinoma of the cervix, or other solid tumors treated curatively and with evidence of no recurrence for at least 5 years prior to randomization
- •Unable to sign informed consent
研究者
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