non-metastatic resectable pancreatic cancer MedDRA version: 21.0 Level: LLT Classification code 10033602 Term: Pancreatic adenocarcinoma resectable System Organ Class: 100000004864
Conditions
Interventions
Trade Name: LEUCOVORIN CALCIUM
Product Name: Leucovorin calcium
Pharmaceutical Form: Powder for solution for injection/infusion
INN or Proposed INN: Calcium folinate
CAS Number: 1492-18-8
Current Spon
Sponsors
Erasmus MC
Eligibility
Sex/Gender
All
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. 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 189 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 189
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) <2cm, and gastrointestinal stromal tumor (GIST) <2cm), unless no evidence of disease and diagnosed more than 3 years before diagnosis of pancreatic cancer, or with a life expectancy of more than 5 years from date of inclusion. • Pregnancy or lactation. • Serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate whether 8 cycles of neoadjuvant mFOLFIRINOX followed by resection and 4 cycles of adjuvant mFOLFIRINOX improves overall survival compared to resection and 12 cycles of adjuvant mFOLFIRINOX in resectable pancreatic cancer. ;Secondary Objective: 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 To investigate in investigational arm only: • Clinical response rate • Serum CA 19-9 and CEA response • Pathologic response ;Primary end point(s): The primary endpoint for the study is overall survival (OS). ;Timepoint(s) of evaluation of this end point: LPLV | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • 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 (R0) • Lymph node-negative resection rate (N0) • 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 ;Timepoint(s) of evaluation of this end point: LPLV | — |
Countries
Netherlands
Contacts
Public Contactresearch coordinator
Erasmus MC
Outcome results
None listed