Evaluation of tumoral perfusion modification by dynamic imaging after neoadjuvant chemotherapy combining gemcitabine and a Hedgehog inhibitor (Vismodegib) in patients with resectable pancreatic adenocarcinoma - NEOPACHI-001

CUB Erasme Hospital0 个研究点开始时间: 2012年10月18日最近更新: 2016年7月21日

适应症

试验速览

暂无简介。

•Histo(cyto)logically proven ductal pancreatic adenocarcinoma;
•Resectable or potentially resectable tumor; resectability assessed during a multidisciplinary meeting with expert surgeon and radiologist;
•First line chemotherapy;
•Age > 18 years;
•WHO performance status (PS) grade 0 or 1;
•Absolute neutrophil count > 1.5 x 10 9 / L, platelets > 100 x 10 9/ L, creatinine clearance (Cockroft and Gault formula) > 60 ml/min, haemoglobin level > 10 g/dl (transfusions authorized), bilirubin<1.5 g/dl;
•Optimal biliary drainage;
•Women of child-bearing potential (WCBP), defined as a sexually mature woman who has not undergone a hysterectomy or tubal ligation of who has not been naturally postmenopausal for at least 24 consecutive months, must have a negative serum or urine pregnancy test prior to treatment. All WCBP, all sexually active male patients, and all partners of patients must agree to use adequate methods of birth control throughout the study;
•Written informed consent.
•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 14
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 7

•Locally advanced non resectable or metastatic pancreatic adenocarcinoma;
•Previous anticancer therapy for the pancreatic adenocarcinoma;
•Biliary obstruction without endoscopic biliary drainage;
•Any contre-indication for surgery;
•Prior malignancy (except non-melanoma skin cancer, and in situ carcinoma of the uterine cervix treated with a curative intent and any other tumor in CR with a disease-free interval > 3 years);
•Uncontrolled congestive heart failure or angina pectoris, myocardial infarction within 1 year prior to study entry, uncontrolled hypertension (systolic pressure > 160 mm or diastolic pressure > 100 mm under well conducted antihypertensive treatment), QT prolongation;
•Major uncontrolled infection;
•Severe hepatic impairment;
•Any medical, psychological, or social condition, which, in the opinion of the investigator, could hamper patient’s compliance to the study protocol and/or assessment/interpretation of the data;
•Pregnant or lactating women, or patients of both genders with procreative potential not using adequate contraceptive methods;
•Patients receiving or having received any investigational treatment within 4 weeks prior to study entry, or participating to another clinical study;Subject previously enrolled into this study.

发起方

CUB Erasme Hospital