Neoadjuvant Chemotherapy for Resectable Cancer of the Pancreatic Head

Neodajuvant chemotherapy with gemcitabine / cisplatin is applied to patients with resectable cancer of pancreatic head. Two cycles of chemotherapy are given on day 1 and 15 each. After restaging excludes disease progression, a standard Whipple procedure is performed.

Staging and restaging procedures include abdominal CT, diagnostic laparoscopy, PET/CT, tumor markers (CEA, CA 19-9) and assessment of the quality of life by the QLQ-30.

• Trial with medicinal product

Inclusion criteria

- Age > 18 years

• Histologically or cytologically confirmed resectable ductal adenocarcinoma of the pancreatic head
• WHO-performance status 0-2
• Written informed consent
• Discussion in an intrdisciplinary conference

Exclusion criteria

- Insufficient renal function (calculated creatinin clearance < 60ml(min)

• Insufficient hematologic function (neutrophil count <1'000/ul, platelets < 100'000/ul)
• Uncorrectable coagulopathy
• Severe cholestasis (bilirubin >100mmol/l)
• Distant metastases in liver, lungs or other organs
• Peritoneal carcinomatosis
• Unresectable tumor (s. 4.2.)
• Contraindication for Whipple procedure
• Uncontrolled infection
• Neurotphil count > °2
• Estimated life experience < 6 months
• HIV Infection
• Severe medical or psychatric comorbidities which interefere with the participation in this trial or the informed consent
• Female patients in child-bearing age without adequate contraception