EUCTR2012-003516-31-BE
Active, not recruiting
Phase 1
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 sitesOctober 18, 2012
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Potentially resectable pancreatic ductal adenocarcinoma
- Sponsor
- CUB Erasme Hospital
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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;
Outcomes
Primary Outcomes
Not specified
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