pancreatic cancer resectable pancreatic cancer
Conditions
Interventions
Patients in the intervention arm receive 8 cycles of neoadjuvant mFOLFIRINOX
followed by surgical resection and 4 cycles of adjuvant mFOLFIRINOX. Patients
in the comparator arm undergo surgical rese
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Histologically or cytologically (Bethesda 5 or 6) confirmed pancreatic ductal adenocarcinoma. • Resectable tumor according to DPCG criteria: no arterial contact and venous contact with the superior mesenteric vein or portal vein of 90 degrees or less • No evidence for metastatic disease* • WHO performance status of 0 or 1 • Ability to undergo surgery and mFOLFIRINOX chemotherapy • Leucocytes (WBC) >= 3.0 X 109/L • Platelets >= 100X 109/L • Hemoglobin >= 6.0 mmol/l • Renal function: eGFR >= 40 ml/min • Age >= 18 years • Written informed consent * Lesions on chest CT that are too small to characterize are not considered metastatic disease.
Exclusion criteria
Exclusion criteria: • Prior radiotherapy, chemotherapy, or surgery for pancreatic cancer. • Prior chemotherapy precluding mFOLFIRINOX. • Previous malignancy (excluding non-melanoma skin cancer, pancreatic neuroendocrine tumor (pNET)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is overall survival by intention to treat. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare between the study arms: • Progression free survival (PFS) • Distant metastases free survival • Locoregional progression free survival • Distant metastases free interval • Locoregional progression free interval • Chemotherapy start rate • Number of chemotherapy cycles received • Chemotherapy completion rate • Dose intensity • Staging laparoscopy rate • Laparoscopy yield • Surgical exploration rate • Resection rate • Microscopically margin-negative resection rate • Lymph node-negative resection rate • Adverse events • Postoperative complications • Quality of life • Serum CA 19-9 and CEA response To investigate in arm 1 only: • Clinical response rate • Pathologic response | — |
Countries
Netherlands
Outcome results
None listed