Actively Recruiting
Perioperative or Adjuvant mFOLFIRINOX for Resectable Pancreatic Cancer
Led by Erasmus Medical Center · Updated on 2024-08-28
378
Participants Needed
22
Research Sites
407 weeks
Total Duration
On this page
Sponsors
E
Erasmus Medical Center
Lead Sponsor
D
Dutch Pancreatic Cancer Group
Collaborating Sponsor
AI-Summary
What this Trial Is About
The PREOPANC-3 study is a randomized, multicenter, phase 3 trial. Patients with resectable pancreatic cancer will be randomly assigned (1:1) to 8 cycles of neoadjuvant mFOLFIRINOX followed by surgery and 4 cycles of adjuvant mFOLFIRINOX (arm 1) or to upfront surgery followed by 12 cycles of adjuvant mFOLFIRINOX (arm 2). The primary objective of the trial is to determine whether perioperative mFOLFIRINOX improves overall survival compared with adjuvant mFOLFIRINOX in patients with resectable pancreatic cancer.
CONDITIONS
Official Title
Perioperative or Adjuvant mFOLFIRINOX for Resectable Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (Bethesda 5 or 6)
- Tumor must be resectable with no arterial contact and venous contact with superior mesenteric vein or portal vein of 90 degrees or less
- No evidence of metastatic disease
- WHO performance status of 0 or 1
- Able to undergo surgery and mFOLFIRINOX chemotherapy
- Leucocytes (WBC) greater than or equal to 3.0 x 10^9/L
- Platelets greater than or equal to 100 x 10^9/L
- Hemoglobin greater than or equal to 6.0 mmol/l
- Renal function with eGFR greater than or equal to 40 ml/min
- Age 18 years or older
- Provided written informed consent
You will not qualify if you...
- Prior radiotherapy, chemotherapy, or surgery for pancreatic cancer
- Prior chemotherapy that prevents use of mFOLFIRINOX
- Previous malignancy except non-melanoma skin cancer, pancreatic neuroendocrine tumor under 2cm, or gastrointestinal stromal tumor under 2cm, unless no disease evidence and diagnosed over 3 years before pancreatic cancer or life expectancy over 5 years
- Pregnancy or lactation
- Serious systemic disorders that may compromise safety or study completion, as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 22 locations
1
Jeroen Bosch Hospital
's-Hertogenbosch, Netherlands
Actively Recruiting
2
Meander Medical Center
Amersfoort, Netherlands
Actively Recruiting
3
Amsterdam UMC
Amsterdam, Netherlands
Actively Recruiting
4
OLVG
Amsterdam, Netherlands
Actively Recruiting
5
Amphia Hospital
Breda, Netherlands
Actively Recruiting
6
Deventer Hospital
Deventer, Netherlands
Actively Recruiting
7
Catharina Hospital
Eindhoven, Netherlands
Actively Recruiting
8
Medisch Spectrum Twente
Enschede, Netherlands
Actively Recruiting
9
University Medical Center Groningen
Groningen, Netherlands
Actively Recruiting
10
Tjongerschans Hospital
Heerenveen, Netherlands
Actively Recruiting
11
Medical Center Leeuwarden
Leeuwarden, Netherlands
Actively Recruiting
12
Leiden University Medical Center
Leiden, Netherlands
Actively Recruiting
13
Maastricht UMC+
Maastricht, Netherlands
Actively Recruiting
14
Radboud University Medical Center
Nijmegen, Netherlands
Actively Recruiting
15
Erasmus MC University Medical Center
Rotterdam, Netherlands
Actively Recruiting
16
Maasstad Ziekenhuis
Rotterdam, Netherlands
Actively Recruiting
17
Regional Academic Center Utrecht, Antonius Hospital
Utrecht, Netherlands
Actively Recruiting
18
Isala Hospital
Zwolle, Netherlands
Actively Recruiting
19
Oslo University Hospital
Oslo, Norway
Not Yet Recruiting
20
Sahlgrenska University Hospital
Gothenburg, Sweden
Actively Recruiting
21
Skåne University Hospital
Lund, Sweden
Actively Recruiting
22
Karolinska University Hospital
Stockholm, Sweden
Actively Recruiting
Research Team
S
Study coordinator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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