DRKS00015766
Recruiting
Phase 1
Safety of multimodality treatment with a combination ofintraoperative Chemotherapy and surgical Resection in locallyconfined or borderline resectable pancreatic cancer - combiCaRe
niversitätsklinikum Heidelberg0 sites40 target enrollmentOctober 23, 2018
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- (Borderline) Resectable ductal adenocarcinoma of the pancreatic head
- Sponsor
- niversitätsklinikum Heidelberg
- Enrollment
- 40
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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