Phase
Condition
Pancreatic Disorders
Digestive System Neoplasms
Cancer
Treatment
Resection
Irinotecan Hydrochloride
Leucovorin Calcium
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Histologically or cytologically (Bethesda 5 or 6) confirmed pancreatic ductaladenocarcinoma.
Resectable tumor according to Dutch Pancreatic Cancer Group criteria: no arterialcontact and venous contact with the superior mesenteric vein or portal vein of 90degrees 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 10^9/L
Platelets ≥ 100 x 10^9/L
Hemoglobin ≥ 6.0 mmol/l
Renal function: eGFR ≥ 40 ml/min
Age ≥ 18 years
Written informed consent
Exclusion
Exclusion Criteria:
Prior radiotherapy, chemotherapy, or surgery for pancreatic cancer.
Prior chemotherapy precluding mFOLFIRINOX.
Previous malignancy (excluding non-melanoma skin cancer, pancreatic neuroendocrinetumor (pNET) <2cm, and gastrointestinal stromal tumor (GIST) <2cm), unless noevidence of disease and diagnosed more than 3 years before diagnosis of pancreaticcancer, 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 thepatient or his/her ability to complete the study, at the discretion of theinvestigator.
Study Design
Connect with a study center
Jeroen Bosch Hospital
's-Hertogenbosch,
NetherlandsSite Not Available
Meander Medical Center
Amersfoort,
NetherlandsSite Not Available
Amsterdam UMC
Amsterdam,
NetherlandsSite Not Available
OLVG
Amsterdam,
NetherlandsSite Not Available
Amphia Hospital
Breda,
NetherlandsSite Not Available
Deventer Hospital
Deventer,
NetherlandsSite Not Available
Catharina Hospital
Eindhoven,
NetherlandsSite Not Available
Medisch Spectrum Twente
Enschede,
NetherlandsSite Not Available
University Medical Center Groningen
Groningen,
NetherlandsSite Not Available
Tjongerschans Hospital
Heerenveen,
NetherlandsSite Not Available
Medical Center Leeuwarden
Leeuwarden,
NetherlandsSite Not Available
Leiden University Medical Center
Leiden,
NetherlandsSite Not Available
Maastricht UMC+
Maastricht,
NetherlandsSite Not Available
Radboud University Medical Center
Nijmegen,
NetherlandsSite Not Available
Erasmus MC University Medical Center
Rotterdam,
NetherlandsSite Not Available
Maasstad Ziekenhuis
Rotterdam,
NetherlandsSite Not Available
Regional Academic Center Utrecht, Antonius Hospital
Utrecht,
NetherlandsSite Not Available
Isala Hospital
Zwolle,
NetherlandsSite Not Available
Oslo University Hospital
Oslo,
NorwaySite Not Available
Sahlgrenska University Hospital
Gothenburg,
SwedenSite Not Available
Skåne University Hospital
Lund,
SwedenSite Not Available
Karolinska University Hospital
Stockholm,
SwedenSite Not Available

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