Perioperative or Adjuvant mFOLFIRINOX for Resectable Pancreatic Cancer
NCT ID: NCT04927780
Last Updated: 2024-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
378 participants
INTERVENTIONAL
2021-09-07
2029-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1: Perioperative mFOLFIRINOX
Patients in the intervention arm (arm 1) start with neoadjuvant mFOLFIRINOX (consisting of oxaliplatin 85 mg/m², irinotecan 150 mg/m², leucovorin 400 mg/m², all at day 1, and fluorouracil continuous IV infusion 2.4 g/m² over 46 hours). Cycles are repeated every 14 days. After eight cycles, surgical resection is performed in the absence of unresectable or metastatic disease. After resection, four cycles of adjuvant mFOLFIRINOX are scheduled.
Leucovorin Calcium
IV
Fluorouracil
IV
Irinotecan Hydrochloride
IV
Oxaliplatin
IV
Resection
Open or minimally-invasive pancreatectomy.
Arm 2: Adjuvant mFOLFIRINOX
Patients in the comparator arm (arm 2) start with surgery. After resection, 12 cycles of adjuvant mFOLFIRINOX (consisting of oxaliplatin 85 mg/m², irinotecan 150 mg/m², leucovorin 400 mg/m², all at day 1, and fluorouracil continuous IV infusion 2.4 g/m² over 46 hours) are scheduled.
Leucovorin Calcium
IV
Fluorouracil
IV
Irinotecan Hydrochloride
IV
Oxaliplatin
IV
Resection
Open or minimally-invasive pancreatectomy.
Interventions
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Leucovorin Calcium
IV
Fluorouracil
IV
Irinotecan Hydrochloride
IV
Oxaliplatin
IV
Resection
Open or minimally-invasive pancreatectomy.
Eligibility Criteria
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Inclusion Criteria
* Resectable tumor according to Dutch Pancreatic Cancer Group 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 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 Criteria
* 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.
18 Years
ALL
No
Sponsors
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Dutch Pancreatic Cancer Group
UNKNOWN
Dutch Cancer Society
OTHER
Erasmus Medical Center
OTHER
Responsible Party
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Bas Groot Koerkamp, MD, PhD
Principal Investigator
Principal Investigators
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Bas Groot Koerkamp, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Erasmus MC University Medical Center
Locations
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Jeroen Bosch Hospital
's-Hertogenbosch, , Netherlands
Meander Medical Center
Amersfoort, , Netherlands
Amsterdam UMC
Amsterdam, , Netherlands
OLVG
Amsterdam, , Netherlands
Amphia Hospital
Breda, , Netherlands
Deventer Hospital
Deventer, , Netherlands
Catharina Hospital
Eindhoven, , Netherlands
Medisch Spectrum Twente
Enschede, , Netherlands
University Medical Center Groningen
Groningen, , Netherlands
Tjongerschans Hospital
Heerenveen, , Netherlands
Medical Center Leeuwarden
Leeuwarden, , Netherlands
Leiden University Medical Center
Leiden, , Netherlands
Maastricht UMC+
Maastricht, , Netherlands
Radboud University Medical Center
Nijmegen, , Netherlands
Erasmus MC University Medical Center
Rotterdam, , Netherlands
Maasstad Ziekenhuis
Rotterdam, , Netherlands
Regional Academic Center Utrecht, Antonius Hospital
Utrecht, , Netherlands
Isala Hospital
Zwolle, , Netherlands
Oslo University Hospital
Oslo, , Norway
Sahlgrenska University Hospital
Gothenburg, , Sweden
Skåne University Hospital
Lund, , Sweden
Karolinska University Hospital
Stockholm, , Sweden
Countries
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Central Contacts
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References
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van Dam JL, Verkolf EMM, Dekker EN, Bonsing BA, Bratlie SO, Brosens LAA, Busch OR, van Driel LMJW, van Eijck CHJ, Feshtali S, Ghorbani P, de Groot DJA, de Groot JWB, Haberkorn BCM, de Hingh IH, van der Holt B, Karsten TM, van der Kolk MB, Labori KJ, Liem MSL, Loosveld OJL, Molenaar IQ, Polee MB, van Santvoort HC, de Vos-Geelen J, Wumkes ML, van Tienhoven G, Homs MYV, Besselink MG, Wilmink JW, Groot Koerkamp B; Dutch Pancreatic Cancer Group. Perioperative or adjuvant mFOLFIRINOX for resectable pancreatic cancer (PREOPANC-3): study protocol for a multicenter randomized controlled trial. BMC Cancer. 2023 Aug 7;23(1):728. doi: 10.1186/s12885-023-11141-5.
Other Identifiers
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2020-005141-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MEC-2021-0002
Identifier Type: -
Identifier Source: org_study_id
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