Perioperative versus adjuvant FOLFIRINOX for resectable pancreatic cancer: the PREOPANC-3 study.

Phase 3

Recruiting

Conditions: pancreatic cancer
resectable pancreatic cancer
10015674
10017991

Registration Number: NL-OMON54274

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 303

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

• 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint is overall survival by intention to treat.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To compare between the study arms:<br /><br>• Progression free survival (PFS)<br /><br>• Distant metastases free survival<br /><br>• Locoregional progression free survival<br /><br>• Distant metastases free interval<br /><br>• Locoregional progression free interval<br /><br>• Chemotherapy start rate<br /><br>• Number of chemotherapy cycles received<br /><br>• Chemotherapy completion rate<br /><br>• Dose intensity<br /><br>• Staging laparoscopy rate<br /><br>• Laparoscopy yield<br /><br>• Surgical exploration rate<br /><br>• Resection rate<br /><br>• Microscopically margin-negative resection rate<br /><br>• Lymph node-negative resection rate<br /><br>• Adverse events<br /><br>• Postoperative complications<br /><br>• Quality of life<br /><br>• Serum CA 19-9 and CEA response<br /><br><br /><br>To investigate in arm 1 only:<br /><br>• Clinical response rate<br /><br>• Pathologic response</p><br>