CONKO-005: adjuvant Therapy in R0-resected Pancreatic Cancer Patients with Gemcitabine plus Erlotinib vs. Gemcitabine over 24 Weeks - a Prospective, Randomized Phase III Study

INTERVENTION: Intervention 1: Arm A: Erlotinib 100 mg p.o. daily plus Gemcitabin 1000 mg/m² i.v. day 1, 8, 15. repetition day 29 Duration: 6 cycles (24 weeks) Intervention 2: Arm B: Gemcitabin 1000 mg/m² i.v. day 1, 8, 15. repetition day 29 CONDITION: C25 ‐ Malignant neoplasm of pancreas PRIMARY OUTCOME: Relaps‐free survival (RFS) SECONDARY OUTCOME: Overall survival, Toxicity 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. Result of resection: R0, 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 × 109 /l, platelets > 100 x 109/l, 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 2 weeks after resection but not before completion of the wound healing at l