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NCT04927780 · CITED IN SOURCE DOCUMENTS

Perioperative or Adjuvant mFOLFIRINOX for Resectable Pancreatic Cancer

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
ACTIVE NOT RECRUITING
Registry last update
2026-05-15

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
Inclusion Criteria: * Histologically or cytologically (Bethesda 5 or 6) confirmed pancreatic ductal adenocarcinoma. * 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 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.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    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.
    intervention Names
    1. Drug: Leucovorin Calcium
    2. Drug: Fluorouracil
    3. Drug: Irinotecan Hydrochloride
    4. Drug: Oxaliplatin
    5. Procedure: Resection
    label
    Arm 1: Perioperative mFOLFIRINOX
    type
    EXPERIMENTAL
  2. description
    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.
    intervention Names
    1. Drug: Leucovorin Calcium
    2. Drug: Fluorouracil
    3. Drug: Irinotecan Hydrochloride
    4. Drug: Oxaliplatin
    5. Procedure: Resection
    label
    Arm 2: Adjuvant mFOLFIRINOX
    type
    ACTIVE_COMPARATOR
interventions
  1. arm Group Labels
    1. Arm 1: Perioperative mFOLFIRINOX
    2. Arm 2: Adjuvant mFOLFIRINOX
    description
    IV
    name
    Leucovorin Calcium
    type
    DRUG
  2. arm Group Labels
    1. Arm 1: Perioperative mFOLFIRINOX
    2. Arm 2: Adjuvant mFOLFIRINOX
    description
    IV
    name
    Fluorouracil
    type
    DRUG
  3. arm Group Labels
    1. Arm 1: Perioperative mFOLFIRINOX
    2. Arm 2: Adjuvant mFOLFIRINOX
    description
    IV
    name
    Irinotecan Hydrochloride
    type
    DRUG
  4. arm Group Labels
    1. Arm 1: Perioperative mFOLFIRINOX
    2. Arm 2: Adjuvant mFOLFIRINOX
    description
    IV
    name
    Oxaliplatin
    type
    DRUG
  5. arm Group Labels
    1. Arm 1: Perioperative mFOLFIRINOX
    2. Arm 2: Adjuvant mFOLFIRINOX
    description
    Open or minimally-invasive pancreatectomy.
    name
    Resection
    type
    PROCEDURE
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
378
type
ESTIMATED
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    The time between randomization and death from any cause. Patients alive at last follow-up are censored.
    measure
    Overall survival
    time Frame
    Up to 5 years after randomization.
secondary Outcomes
  1. description
    The time between randomization and locoregional progressive disease before or during treatment (resulting in irresectability), the occurrence of distant metastases, recurrent pancreatic cancer after surgery or death from any cause. Patients alive and free of these events at last follow-up are censored.
    measure
    Progression free survival
    time Frame
    Up to 5 years after randomization.
  2. description
    The time between randomization and the occurrence of distant metastases or death from any cause. Patients alive and free of these events at last follow-up are censored.
    measure
    Distant metastases free survival
    time Frame
    Up to 5 years after randomization.
  3. description
    The time between randomization and locoregional progression before or during treatment (resulting in irresectability), locoregional recurrence after resection or death from any cause. Patients alive and free of these events at last follow-up are censored.
    measure
    Locoregional progression free survival
    time Frame
    Up to 5 years after randomization.
  4. description
    The time between randomization and the occurrence of distant metastases. Distant metastases are considered an event and patients are censored at death or last follow-up when without this event.
    measure
    Distant metastases free interval
    time Frame
    Up to 5 years after randomization.
  5. description
    The time between randomization and locoregional progression before or during treatment (resulting in irresectability), or locoregional recurrence after resection. Locoregional progressive disease before or during treatment or locoregional recurrence after resection are considered an event and patients are censored at death or last follow-up when free of these events.
    measure
    Locoregional progression free interval
    time Frame
    Up to 5 years after randomization.
  6. description
    The percentage of patients who received at least one cycle of scheduled chemotherapy.
    measure
    Chemotherapy start rate
    time Frame
    4 months
  7. description
    The number of mFOLFIRINOX cycles patients received.
    measure
    Number of chemotherapy cycles received.
    time Frame
    9 months
  8. description
    The percentage of patients who completed all cycles of scheduled chemotherapy.
    measure
    Chemotherapy completion rate
    time Frame
    9 months
  9. description
    The amount of drug delivered as a percentage of planned dose according to the protocol.
    measure
    Dose intensity
    time Frame
    9 months
  10. description
    The percentage of patients that actually underwent a staging laparoscopy, regardless whether a surgical exploration or resection was performed.
    measure
    Staging laparoscopy rate
    time Frame
    At the time of surgery.
  11. description
    The percentage of patients that underwent staging laparoscopy and were diagnosed with metastatic or unresectable disease during this procedure.
    measure
    Laparoscopy yield
    time Frame
    At the time of surgery.
  12. description
    The percentage of patients who underwent a surgical exploration (open or minimally-invasive), regardless whether a resection was performed.
    measure
    Surgical exploration rate
    time Frame
    At the time of surgery.
Full study description
brief Summary
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.
Source references
references
  1. citation
    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.
    pmid
    37550634
    type
    BACKGROUND
Source notices and limitations
    Discovery and provenance
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        l chemotherapy regimens are being evaluated in the following trials: <a href="/clinicaltrials/NCT04340141">ALLIANCE</a> (NCT04340141), <a href="/clinicaltrials/NCT04927780">PREOPANC-3</a> (NCT04927780), <a href="/clinicaltrials/NCT02959879">PANACHE-01-PRODIGE</a> (NCT02959879), and <a href="/clinicaltrials/NCT02919787">NorPACT-01
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        eing evaluated in the following trials: <a href="/clinicaltrials/NCT04340141">ALLIANCE</a> (NCT04340141), <a href="/clinicaltrials/NCT04927780">PREOPANC-3</a> (NCT04927780), <a href="/clinicaltrials/NCT02959879">PANACHE-01-PRODIGE</a> (NCT02959879), and <a href="/clinicaltrials/NCT02919787">NorPACT-01</a> (NCT02919787).</p></li><
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      source update dates
      1. context
        Updated: February 12, 2025
        datetime
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        display
        February 12, 2025

    Preserved source evidence · Not medical advice