(Borderline) Resectable ductal adenocarcinoma of the pancreatic head C25.0
Conditions
Interventions
Group 1: Perioperative chemotherapy with 5-Fluoruracil (5-FU) and calcium folinate, (Partial) pancreaticoduodenectomy
Chemotherapy with 5-FU is started one day prior to surgery and continued until postoperative day 1. Overall, 1000 mg/m² per day are applied i.v. for 48 hours (total dose 2000 mg/m²). Immediately prior
Sponsors
Universitätsklinikum Heidelberg
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion 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
Exclusion criteria: distant metastatic disease; renal disease, creatinine clearance 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 30-day complication rate according to the Clavien-Dindo classification | — |
Secondary
| Measure | Time frame |
|---|---|
| 60-day complication rate according to the Clavien-Dindo classification; 30-and 60-day mortality; pancreas-associated postoperative morbidity: postoperative pancreatic fistula (POPF, according to the ISGPS classification), intraabdominal fluid-collection or abscess, delayed gastric emptying (DGE) and postpancreatectomy hemorrhage (according to the ISGPS definitions); bile leakage; perioperative bleeding; gastrointestinal bleeding; postoperative ileus; duration of intensive care unit (ICU) stay (postoperative and readmissions); postoperative duration of hospital stay; need for readmission; anemia (Hb 5 x ULN, ALT > 5 x ULN, AP > 5 x ULN, GGT, bilirubine > 1.5 x ULN); cardiotoxicity (continuous ECG Monitoring during and until 24 hours post perioperative chemotherapy); bronchospasm; perioperative tumor cell dissemination (circulating tumor cells, CTCs); pharmacokinetics of perioperative chemotherapy | — |
Countries
Germany
Contacts
Public ContactSusanne Roth
Chirurgische Klinik, Abteilung für Allgemein-, Viszeral-und Transplantationschirurgie, Universitätsklinikum Heidelberg
Outcome results
None listed