Table 1.
Eligibility criteria for the NEONAX-trial
| 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. |