resectable adenocarcinoma of the pancreas MedDRA version: 20.0 Level: LLT Classification code 10033578 Term: Pancreas carcinoma resectable System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10052747 Term: Adenocarcinoma pancreas System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Institut für Klinisch-Onkologische Forschung Krankenhaus Nordwest GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Histologically confirmed adenocarcinoma of the pancreas 2.Radiological confirmation of a local curative resectable (primarily resectable or borderline situation) pancreas carcinoma without distant metastases 3.no prior pancreas resection 4. no prior cytostatic chemotherapy 5. Male and female patients aged = 18 and = 75 years 6. ECOG = 1 7. medical operability 8. Granulocytes > 1.500/µl 9. Thrombocytes > 100.000/µl 10. Hemoglobin = 8,0 g/dl 11. Serumcreatinine = 1.5x of normal value or Creatinine-Clearance > 50 ml/min 12. Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 126 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 126
Exclusion criteria
Exclusion criteria: 1. Endocrine pancreas carcinoma 2. Locally advanced inoperable stages 3. distant metastases 4. relapse 5. prior radiotherapy of the measurable lesions 6. Peritoneal carcinomatosis 7. Malignant secondary disease dating back 3,5xULN, AP>6xULN) 11. transhepatic drainage 12. Active CAD, cardiomyopathy or NYHA stage III-IV heart failure and EF NCI grade II 17. Pregnancy or lactation 18. hypersensitivity or contraindication to Gemcitabine, Oxaliplatin, Natrium folinate, Irinotecan, 5-Fluorouracil 19. Participation in another interventional study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: overall survival;Secondary Objective: Progression-free survival (PFS) R0 resection rate perioperative 30-day morbidity pathological complete remission feasibility and safety of perioperative Folfirinox regarding prophylactic use of G-CSF prevalence of iron deficiency anemia during perioperative therapy;Primary end point(s): median overall survival;Timepoint(s) of evaluation of this end point: continuously | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): progression free survival (PFS) R0 resection rate perioperative 30-day morbidity pathological complete remission feasibility and safety of perioperative Folfirinox regarding prophylactic use of G-CSF prevalence of iron deficiency anemia during perioperative therapy;Timepoint(s) of evaluation of this end point: PFS, safety: continuously R0 resection rate: after surgery perioperative 30-day morbidity: 30 days after surgery iron deficiency: day 1 of every cycle | — |
Countries
Germany
Contacts
Public ContactIKF
Institut für Klinisch-Onkologische Forschung Krankenhaus Nordwest GmbH
Outcome results
None listed