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Table 1 Eligibility Criteria

From: A Randomized Multicentre Phase II Trial Comparing Adjuvant Therapy in Patients with Interferon Alpha-2b and 5-FU Alone or in Combination with Either External Radiation Treatment and Cisplatin (CapRI) or Radiation alone regarding Event-Free Survival – CapRI-2

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