EUCTR2008-004637-16-IT进行中（未招募）不适用
Folfiri as Second-Line chemotherapy for Advanced Pancreatic cancer:a GISCAD Phase II study - SLAP (Second Line Advanced Pancreas)
GISCAD0 个研究点开始时间: 2012年4月10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
- •-Signed written informed consent prior to beginning protocol specific procedures
- •-Previous chemotherapy (one line only) with Gemcitabine +/- Platinoids (Cisplatin,Oxaliplatin,Carboplatin)
- •-Previous gemcitabine delivered as a radiosensitizer for locally advanced disease, followed or not by a gemcitabine+/-platinoids as manteinance or disease progression is allowed.
- •-Male or female < 75 years of age
- •-Diagnosis of histologically and/or citologically confirmed adenocarcinoma of the pancreas
- •-Locally advanced (non-resectable) or metastatic pancreatic cancer
- •-Presence of at least one uni-dimensional indicator lesion measurable by CT scan or MRI in not an irradiated area
- •-ECOG performance status 0-1 at study entry
- •-Life expectancy =/> 3 months
- •-Neutrophils =/> 1.5 x 109/L, platelets =/> 100 x 109/L, and hemoglobin =/> 10 g/dL
- •-Bilirubin level either normal or =/< 1.5 x ULN
- •-ASAT and ALAT =/< 2.5 x ULN (=/< 5 x ULN if liver metastasis are present)
- •-Serum creatinine < 1.5 x ULN
- •-Amylase =/< 1.5 ULN
- •-Effective contraception for both male and female patients if the risk of conception exists
- •-Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before registration in the trial
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Chemo-naive patients
- •-Brain metastases
- •-Previous treatment with irinotecan or fluoropyrimidines(5-Fluorouracil.Capecitabine,UFT,S-1)
- •-Significant cardiovascular disease (clinically relevant coronary artery disease or a history of a myocardial infarction within the last 6 months)
- •-Significant gastrointestinal abnormalities
- •-Gilbert's Syndrome
- •-Any uncontrolled infections
- •-Known HIV infection
- •-Radiotherapy within 4 weeks prior to study entry
- •-Any investigational agents 4 weeks prior to entry
- •-Known grade 3 or 4 allergic reaction to any of the components of the treatment
- •-Known drug abuse/ alcohol abuse
- •-Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
- •-Women who are pregnant or breastfeeding
- •-Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. (Patients with a previous malignancy but without evidence of disease for ≥ 5 years will be allowed to enter the trial).
- •-Legal incapacity or limited legal capacity
研究者
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