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NCT Number: NCT04927780

Perioperative or Adjuvant mFOLFIRINOX for Resectable Pancreatic Cancer

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Ductal Adenocarcinoma Pancreatic Neoplasms Resectable Pancreatic Adenocarcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Jeroen Bosch Hospital, 's-Hertogenbosch, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

leucovorin calcium

Drug

IV

Fluorouracil

Drug

IV

irinotecan hydrochloride

Drug

IV

Oxaliplatin

Drug

IV

Resection

Procedure

Open or minimally-invasive pancreatectomy.

Primary outcomes

  1. Overall survival

    Time frame: Up to 5 years after randomization.

    The time between randomization and death from any cause. Patients alive at last follow-up are censored.

Secondary outcomes

  1. Progression free survival

    Time frame: Up to 5 years after randomization.

    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.

  2. Distant metastases free survival

    Time frame: Up to 5 years after randomization.

    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.

  3. Locoregional progression free survival

    Time frame: Up to 5 years after randomization.

    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.

  4. Distant metastases free interval

    Time frame: Up to 5 years after randomization.

    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.

  5. Locoregional progression free interval

    Time frame: Up to 5 years after randomization.

    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.

  6. Chemotherapy start rate

    Time frame: 4 months

    The percentage of patients who received at least one cycle of scheduled chemotherapy.

  7. Number of chemotherapy cycles received.

    Time frame: 9 months

    The number of mFOLFIRINOX cycles patients received.

  8. Chemotherapy completion rate

    Time frame: 9 months

    The percentage of patients who completed all cycles of scheduled chemotherapy.

  9. Dose intensity

    Time frame: 9 months

    The amount of drug delivered as a percentage of planned dose according to the protocol.

  10. Staging laparoscopy rate

    Time frame: At the time of surgery.

    The percentage of patients that actually underwent a staging laparoscopy, regardless whether a surgical exploration or resection was performed.

  11. Laparoscopy yield

    Time frame: At the time of surgery.

    The percentage of patients that underwent staging laparoscopy and were diagnosed with metastatic or unresectable disease during this procedure.

  12. Surgical exploration rate

    Time frame: At the time of surgery.

    The percentage of patients who underwent a surgical exploration (open or minimally-invasive), regardless whether a resection was performed.

  13. Resection rate

    Time frame: At the time of surgery.

    The percentage of patients that underwent a curative-intent resection.

  14. Microscopically margin-negative (R0) resection rate

    Time frame: At the time of surgery.

    The percentage of patients that underwent a microscopically margin-negative (R0) resection. The resection is considered R0 if there is no tumor within 1 mm of the margins.

  15. Lymph node-negative (N0) resection rate

    Time frame: At the time of surgery.

    The percentage of patients that underwent a resection with negative lymph nodes (N0) in the surgical specimen.

  16. Pathologic response

    Time frame: At the time of surgery.

    Tumor regression score in the surgical specimen

  17. Adverse events as assessed by the CTCAE version 5.0

    Time frame: Until 30 days after last chemotherapy.

    Adverse events are assessed during neoadjuvant therapy and adjuvant therapy.

  18. Postoperative complications

    Time frame: Up to 90 days after surgery.

    According to the Clavien-Dindo classification and by the International Study Group of Pancreatic Surgery and International Study Group of Liver Surgery.

  19. Serum CA 19-9 and CEA response

    Time frame: 9 months

    The change in carbohydrate antigen 19-9 (CA 19-9) and carcinoembryonic antigen (CEA) after surgery and after 4, 8, and 12 cycles of mFOLFIRINOX compared to baseline.

  20. Clinical response rate according to RECIST criteria version 1.1

    Time frame: At the time of surgery.

    Response comparing baseline and restaging after 4 and 8 cycles of mFOLFIRINOX

  21. Patient reported cancer-specific health-related Quality of Life (HRQoL) as assessed using the EORTC QLQ-C30

    Time frame: Up to 5 years after randomization.

    At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year

  22. Patient reported non-disease specific HRQoL as assessed using the EQ-5D-5L

    Time frame: Up to 5 years after randomization.

    At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year

  23. Patient reported tumor-specific HRQoL as assessed using the EORTC LQPAN26

    Time frame: Up to 5 years after randomization.

    At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year

  24. Patient reported Quality of Life as assessed using the worry of progression of cancer scale (WOPS)

    Time frame: Up to 5 years after randomization.

    At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year

  25. Patient reported chemotherapy-induced peripheral neuropathy as assessed using the EORTC QLQ-CIPN20

    Time frame: Up to 5 years after randomization.

    At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year

  26. Patient reported Quality of Life as assessed using the happiness, hospital, anxiety and depression scale (HADS)

    Time frame: Up to 5 years after randomization.

    At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year

  27. Patient reported Quality of Life as assessed using Exocrine Pancreatic Insufficiency (EPI) questionnaire

    Time frame: Up to 5 years after randomization.

    At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Collaborators

  • Dutch Cancer Society
  • Dutch Pancreatic Cancer Group

Registry information

Official study title

Perioperative Versus Adjuvant FOLFIRINOX for Resectable Pancreatic Cancer: the PREOPANC-3 Study

Acronym: PREOPANC-3

Important dates

Study start
2021
Primary completion
2027
Study completion
2029
First posted
Jun 16, 2021
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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