Inclusion criteria | Exclusion criteria |
---|---|
• R0/R1 resected pancreatic ductal adenocarcinoma | • Metastatic disease |
• Adequate lab parameters (bone marrow-, liver and kidney function; Hb >8.0 g/dl, WBC >3,000 cells/mm3, platelets >75,000 cells/mm3; ALT/AST ≤ 2 ULN; Creatinine ≤1.5 mg/dL and calculated or measured creatinine clearance (CrCl) of ≥ 60 ml/min). | • Previous chemo- or radiotherapy for pancreatic carcinoma |
• Therapy starts within eight weeks after surgery | • Previous radiotherapy in the corresponding region |
• Ability of patient to understand character and individual consequences of clinical trial | • Patients with known severe depression |
• Written informed consent must be available before enrolment in the trial | • Patients with severe heart diseases (NYHA stadium three and four) or severe lung disease (COPD Grade III, Asthma bronchiale Grade IV) |
• For women with childbearing potential, adequate contraception. | • General condition worse than ECOG 2 |
• Age ≥ 18 years | • Pregnancy and lactation |
• History of hypersensitivity to the investigational product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational product | |
• Any contraindication met for any investigational product | |
• Patients with mental diseases ICD-10-code F30, F31, F32.2 ff. or F33.2 ff. | |
• Participation in other clinical trials and observation period of competing trials, respectively. | |
• Serious uncontrolled acute infections at the time of therapy initiation or patients with known HIV infection, other immunodeficiencies or autoimmune diseases |