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Table 1 Eligibility criteria for the NEONAX-trial

From: Neoadjuvant plus adjuvant or only adjuvant nab-paclitaxel plus gemcitabine for resectable pancreatic cancer - the NEONAX trial (AIO-PAK-0313), a prospective, randomized, controlled, phase II study of the AIO pancreatic cancer group

Inclusion criteria:
 • Histologically or cytologically proven clearly resectable ductal adenocarcinoma of the pancreas (PDAC) ≤ cT3 with no prior tumor specific treatment. (After consolidation with the coordinating investigator a cytological determination is possible in exceptional cases.)
 • No evidence of metastases to distant organs (e.g. liver, peritoneum, lung).
 • Resectable tumor. Determination of resectability based on spiral CT scans with both oral and i.v. contrast enhancement or on MRI using a recent consensus definition (Resectability: Clear fat planes around the celiac artery, hepatic artery and superior mesenteric artery. [5, 31])
 • ECOG performance status 0 or 1
 • Creatinine clearance ≥30 ml/min
 • Serum total bilirubin level ≤ 2.5 x ULN
 • ALT and AST ≤ 2.5 x ULN
 • In case of biliary obstruction, biliary decompression is required. Post-interventional bilirubin levels must be ≤2.5 x ULN
 • White blood cell count ≥3.5 × 106/ml, neutrophil granulocytes count ≥1,5 × 106/ml, platelet count ≥100 × 106/ml
 • Signed informed consent incl. Participation in translational research
 • Age ≥ 18 years and < 75 years
Main exclusion criteria
 • Borderline resectable PDAC by radiologic criteria, papillary cancer on neuroendocrine Cancer
 • Radiographic evidence of severe portal hypertension/cavernous transformation
 • Chronic infectious diseases, immune deficiency syndromes
 • Premalignant hematologic disorders, e.g. myelodysplastic syndrome
 • Disability to understand and sign written informed consent document
 • Past or current history of malignancies except for the indication under this study and curatively treated:
  ▪ Basal and squamous cell carcinoma of the skin
  ▪ In-situ carcinoma of the cervix
  ▪ Other malignant disease without recurrence after at least 5 years of follow-up
 • Clinically significant cardiovascular disease (incl. Myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) 6 months before enrollment
 • Clinically relevant or history of interstitial lung disease, e.g. non-infectious pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan or chest x-ray.
 • Pre-existing neuropathy > grade 1 (NCI CTCAE)
 • Pregnancy or breastfeeding women.