Safety of multimodality treatment with a combination ofintraoperative Chemotherapy and surgical Resection in locallyconfined or borderline resectable pancreatic cancer
- Conditions
- (Borderline) Resectable ductal adenocarcinoma of the pancreatic headC25.0Head of pancreas
- Registration Number
- DRKS00015766
- Lead Sponsor
- niversitätsklinikum Heidelberg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
newly diagnosed, resectable or borderline resectable pancreatic cancer located in the head of the pancreas, without arterial involvement, on cross-sectional Imaging (contrast enhanced CT scan) according to the International Study Group of Pancreatic Surgery (ISGPS) criteria; histologically or cytologically proven pancreatic ductal adenocarcinoma (including variants); =18 and =75 years of age;
informed consent; Eastern Cooperative Oncology Group (ECOG) Performance status 0-2; patient considered to tolerate surgery and chemotherapy by a multidisciplinary team; women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation
distant metastatic disease; renal disease, creatinine clearance < 50 ml/min (estimated
by Cockroft-Gault); abnormal hepatic function as defined by a total bilirubine level > 1.5 x the upper limit of normal (ULN), unless the patient has extrahepatic cholestasis due to pancreatic cancer, or alanine aminotransferase (ALT) > 2.5 x ULN, liver cirrhosis (of any Child-Pugh grade); serious cardiovascular disease (e.g. myocardial infarction in the last 12 months, congestive heart failure NYHA III/IV, unstable angina pectoris); severe COPD, GOLD stage > II; American Society of Anesthesiologists (ASA) score > III; active infection, including cholangitis; abnormal bone marrow function, defined as an absolute white blood cell count < 3/nl or platelet count < 100/nl; pernicious anemia or other megaloblastic anemias where
Vitamin B12 is deficient; immunosuppressive therapy; allergy or known intolerance to 5-FU or calcium folinate; patients with a known lack of dihydropyrimidinedehydrogenase (DPD)-activity or patients treated with DPD inhibitors such as brivudine; current pregnancy or breastfeeding; history of another malignancy in the past 5 years; inability to comply with study and/or follow-up procedures; (language) problems in understanding the patient information document explaining the present clinical trial; concurrent participation in another clinical study; any condition which could result in an undue risk for the patient in the opinion of the investigator
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 30-day complication rate according to the Clavien-Dindo<br>classification
- Secondary Outcome Measures
Name Time Method