Neoadjuvant and adjuvant mFOLFIRINOX treatment for resectable pancreatic cancer
Perioperative Versus Adjuvant FOLFIRINOX for Resectable Pancreatic Cancer: the PREOPANC-3 Study
This study is testing if giving a specific chemotherapy treatment before and after surgery helps people with resectable pancreatic cancer live longer compared to just giving it after surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 378 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 22 sites ('s-Hertogenbosch and 21 other locations) |
| Trial ID | NCT04927780 on ClinicalTrials.gov |
What this trial studies
This phase 3 trial investigates the effectiveness of perioperative mFOLFIRINOX compared to adjuvant mFOLFIRINOX in patients with resectable pancreatic cancer. Participants will be randomly assigned to receive either 8 cycles of neoadjuvant mFOLFIRINOX followed by surgery and 4 cycles of adjuvant mFOLFIRINOX, or to undergo upfront surgery followed by 12 cycles of adjuvant mFOLFIRINOX. The primary goal is to assess whether the perioperative approach improves overall survival rates. The study involves multiple centers and aims to provide insights into optimal treatment strategies for this aggressive cancer.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed resectable pancreatic ductal adenocarcinoma and no evidence of metastatic disease.
Not a fit: Patients with prior treatments for pancreatic cancer or those with other malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve overall survival rates for patients with resectable pancreatic cancer.
How similar studies have performed: Previous studies have shown promising results with neoadjuvant chemotherapy approaches in pancreatic cancer, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
's-Hertogenbosch and 21 other locations
- Jeroen Bosch Hospital — 's-Hertogenbosch, Netherlands (Recruiting)
- Meander Medical Center — Amersfoort, Netherlands (Recruiting)
- Amsterdam UMC — Amsterdam, Netherlands (Recruiting)
- Olvg — Amsterdam, Netherlands (Recruiting)
- Amphia Hospital — Breda, Netherlands (Recruiting)
- Deventer Hospital — Deventer, Netherlands (Recruiting)
- Catharina Hospital — Eindhoven, Netherlands (Recruiting)
- Medisch Spectrum Twente — Enschede, Netherlands (Recruiting)
- University Medical Center Groningen — Groningen, Netherlands (Recruiting)
- Tjongerschans Hospital — Heerenveen, Netherlands (Recruiting)
- Medical Center Leeuwarden — Leeuwarden, Netherlands (Recruiting)
- Leiden University Medical Center — Leiden, Netherlands (Recruiting)
- Maastricht UMC+ — Maastricht, Netherlands (Recruiting)
- Radboud University Medical Center — Nijmegen, Netherlands (Recruiting)
- Erasmus MC University Medical Center — Rotterdam, Netherlands (Recruiting)
- Maasstad Ziekenhuis — Rotterdam, Netherlands (Recruiting)
- Regional Academic Center Utrecht, Antonius Hospital — Utrecht, Netherlands (Recruiting)
- Isala Hospital — Zwolle, Netherlands (Recruiting)
- Oslo University Hospital — Oslo, Norway (Not_yet_recruiting)
- Sahlgrenska University Hospital — Gothenburg, Sweden (Recruiting)
- Skåne University Hospital — Lund, Sweden (Recruiting)
- Karolinska University Hospital — Stockholm, Sweden (Recruiting)
Study contacts
- Principal investigator: Bas Groot Koerkamp, MD, PhD — Erasmus MC University Medical Center
- Study coordinator: Study coordinator
- Email: preopanc3@erasmusmc.nl
- Phone: +31 6 50032973
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.