Phase
Condition
Adenocarcinoma
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Histo(cyto)logically proven ductal pancreatic adenocarcinoma;
Resectable or potentially resectable tumor; resectability assessed during amultidisciplinary meeting with expert surgeon and radiologist (cohort 1), or locallyadvanced and/or metastatic tumor (cohort 2);
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, creatinineclearance (Cockcroft 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 hasnot undergone a hysterectomy or tubal ligation of who has not been naturallypostmenopausal for at least 24 consecutive months, must have a negative serum or urinepregnancy test prior to treatment. All WCBP, all sexually active male patients, andall partners of patients must agree to use adequate methods of birth controlthroughout the study;
Signed informed consent.
Exclusion
Exclusion Criteria:
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 theuterine cervix treated with a curative intent and any other tumor in completeremission 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 ordiastolic pressure > 100 mm under well conducted antihypertensive treatment), QTprolongation;
Major uncontrolled infection;
Severe hepatic impairment;
Any medical, psychological, or social condition, which, in the opinion of theinvestigator, could hamper patient's compliance to the study protocol and/orassessment/interpretation of the data;
Pregnant or lactating women, or patients of both genders with procreative potentialnot using adequate contraceptive methods;
Patients receiving or having received any investigational treatment within 4 weeksprior to study entry, or participating to another clinical study; patients previouslyenrolled into this study.
Study Design
Study Description
Connect with a study center
Antwerp University Hospital (UZA)
Edegem, Antwerpen 2650
BelgiumSite Not Available
Erasme University Hospital (ULB)
Brussels, 1070
BelgiumSite Not Available

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