Perioperative or Adjuvant mFOLFIRINOX for Resectable Pancreatic Cancer (PREOPANC-3)
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| ClinicalTrials.gov Identifier: NCT04927780 |
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Recruitment Status :
Recruiting
First Posted : June 16, 2021
Last Update Posted : August 15, 2023
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Sponsor:
Erasmus Medical Center
Collaborators:
Dutch Pancreatic Cancer Group
Dutch Cancer Society
Information provided by (Responsible Party):
Bas Groot Koerkamp, MD, PhD, Erasmus Medical Center
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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 |
| 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
MedlinePlus related topics:
Pancreatic Cancer
| Arm | Intervention/treatment |
|---|---|
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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.
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Drug: Leucovorin Calcium
IV Drug: Fluorouracil IV Drug: Irinotecan Hydrochloride IV Drug: Oxaliplatin IV Procedure: Resection Open or minimally-invasive pancreatectomy. |
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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.
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Drug: Leucovorin Calcium
IV Drug: Fluorouracil IV Drug: Irinotecan Hydrochloride IV Drug: Oxaliplatin IV Procedure: Resection Open or minimally-invasive pancreatectomy. |
Primary Outcome Measures :
- 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 :
- 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.
- 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.
- 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.
- 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.
- 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.
- Chemotherapy start rate [ Time Frame: 4 months ]The percentage of patients who received at least one cycle of scheduled chemotherapy.
- Number of chemotherapy cycles received. [ Time Frame: 9 months ]The number of mFOLFIRINOX cycles patients received.
- Chemotherapy completion rate [ Time Frame: 9 months ]The percentage of patients who completed all cycles of scheduled chemotherapy.
- Dose intensity [ Time Frame: 9 months ]The amount of drug delivered as a percentage of planned dose according to the protocol.
- 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.
- 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.
- 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.
- Resection rate [ Time Frame: At the time of surgery. ]The percentage of patients that underwent a curative-intent resection.
- 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.
- 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.
- Pathologic response [ Time Frame: At the time of surgery. ]Tumor regression score in the surgical specimen
- 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.
- 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.
- 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.
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
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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
| Contact: Study coordinator | +31 6 50032973 | preopanc3@erasmusmc.nl |
Locations
Show 22 study locations
Sponsors and Collaborators
Erasmus Medical Center
Dutch Pancreatic Cancer Group
Dutch Cancer Society
Investigators
| Principal Investigator: | Bas Groot Koerkamp, MD, PhD | Erasmus MC University Medical Center |
Publications:
| 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: | August 15, 2023 |
| Last Verified: | August 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| 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:
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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 |