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Trial record 1 of 1 for:    preopanc-3
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Perioperative or Adjuvant mFOLFIRINOX for Resectable Pancreatic Cancer (PREOPANC-3)

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ClinicalTrials.gov Identifier: NCT04927780
Recruitment Status : Recruiting
First Posted : June 16, 2021
Last Update Posted : June 21, 2022
Sponsor:
Collaborators:
Dutch Pancreatic Cancer Group
Dutch Cancer Society
Information provided by (Responsible Party):
Bas Groot Koerkamp, MD, PhD, Erasmus Medical Center

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.


Condition or disease Intervention/treatment Phase
Pancreatic Cancer Pancreatic Ductal Adenocarcinoma Resectable Pancreatic Adenocarcinoma Drug: Leucovorin Calcium Drug: Fluorouracil Drug: Irinotecan Hydrochloride Drug: Oxaliplatin Procedure: Resection Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 378 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Perioperative Versus Adjuvant FOLFIRINOX for Resectable Pancreatic Cancer: the PREOPANC-3 Study
Actual Study Start Date : September 7, 2021
Estimated Primary Completion Date : February 2026
Estimated Study Completion Date : July 2029

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Drug: Leucovorin Calcium
IV

Drug: Fluorouracil
IV

Drug: Irinotecan Hydrochloride
IV

Drug: Oxaliplatin
IV

Procedure: Resection
Open or minimally-invasive pancreatectomy.

Active Comparator: 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.
Drug: Leucovorin Calcium
IV

Drug: Fluorouracil
IV

Drug: Irinotecan Hydrochloride
IV

Drug: Oxaliplatin
IV

Procedure: Resection
Open or minimally-invasive pancreatectomy.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04927780


Contacts
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Contact: Study coordinator +31 6 50032973 preopanc3@erasmusmc.nl

Locations
Show Show 17 study locations
Sponsors and Collaborators
Erasmus Medical Center
Dutch Pancreatic Cancer Group
Dutch Cancer Society
Investigators
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Principal Investigator: Bas Groot Koerkamp, MD, PhD Erasmus MC University Medical Center
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Responsible Party: Bas Groot Koerkamp, MD, PhD, Principal Investigator, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT04927780    
Other Study ID Numbers: MEC-2021-0002
2020-005141-16 ( EudraCT Number )
First Posted: June 16, 2021    Key Record Dates
Last Update Posted: June 21, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Bas Groot Koerkamp, MD, PhD, Erasmus Medical Center:
Neoadjuvant Therapy
Adjuvant Chemotherapy
Oxaliplatin
Irinotecan
Leucovorin
Fluorouracil
Pancreatic Neoplasms
Pancreatectomy
Additional relevant MeSH terms:
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Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Leucovorin
Fluorouracil
Oxaliplatin
Irinotecan
Calcium
Levoleucovorin
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antidotes