CONKO-006: additive therapy in R1-resected pancreatic cancer with gemcitabine plus sorafenib vs. Gemcitabine plus placebo over 12 months - a double blind, placebo-controlled Phase IIb trial

INTERVENTION: Intervention 1: Arm A: Sorafenib 400 mg twice daily p.o. plus Gecitabine 1000 mg/ m² day 1, 8, 15 repetition day 29 Duration: 12 Month Intervention 2: Arm B: Placebo twice daily plus Gemcitabine 1000 mg/m² day 1, 8, 15 repetition day 29 Duration: 12 Month CONDITION: C25 ‐ Malignant neoplasm of pancreas PRIMARY OUTCOME: Relaps‐free survival SECONDARY OUTCOME: Overall survival; Safety and tolerability; Evaluation of prognostic factors INCLUSION CRITERIA: Histological confirmed diagnosis of an adenocarcinoma of the pancreas, Standardised surgery for tumor resection, e. g. partial pancreatoduodenectomy (Kausch‐Whipple), pylorus‐sparing partial pancreatoduodenectomy (PPPD), pancreas leftresection or total pancreatectomy, Result of resection: R1, No previous neoadjuvant therapy (chemotherapy or radiation), Performance‐Status according to Karnofsky‐Scale > 60 %, Patient compliance and geographical situation allowing an adequate follow up, especially the willingness to visit the same center regulary for at least 2 years after surgery, Sufficient bone marrow capacity: WBC > 3.5 /nl, platelets > 100 /nl, haemoglobin > 8 g/dl, Written informed consent of the patient prioral any precedure in connection with the study, Male and female patients with an age of at least 18 years, Initiation of the adjuvant therapy as soon as possible postoperative. Soonest 4 weeks after resection but not before completion