NeoFOL-R Trial (Perioperative Versus Adjuvnat FOLFIRINOX in Resectable Pancreatic Cancer)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age19-80
SponsorSeoul National University Hospital
About this trial
Rationale: Adjuvant chemotherapy after surgery significantly improved the survival of PC patients, but there is a problem that only about 50% of patients start adjuvant chemotherapy after pancreatectomy. Neoadjuvant chemotherapy might control potential metastatic lesion which are not being detected in early diseases status and improve the R0 resection rate. In addition, it prevents futile surgery by selecting patients with rapid progression of disease. Furthermore, compared to chemotherapy administered after surgery, more patients can complete the planned chemotherapy schedule in neoadjuvant setting. Asians differ from Westerners not only in racial differences, but also in average size and body surface area. Accordingly, there is an urgent need for clinical studies on the dose, toxicity, dosing cycle, and efficacy of anticancer drugs that reflect actual clinical trials in Asian countries for Asians. There are still few studies worldwide that prospectively explored the efficacy of neoadjuvant chemotherapy in resectable PC and the administration of neoadjuvant therapy in resectable PC depends on individual clinical judgment. Therefore, systematic and prospective clinical trials are essential to standardize treatment protocol in resectable PC.
Obective: To investigate whether 6 cycles of preoperative mFOLFIRINOX - surgery - 6 cycles of postoperative mFOLFIRINOX improves overall survival by intention-to-treat compared to surgery followed by 12 cycles of postoperative mFOLFIRINOX.
Study design: open-label, multicenter, randomized, phase 3 clinical trial Study population: Patients with resectable pancreatic cancer and ECOG performance 0 or 1.
Intervention:
Invervention arm : 6 cycles of neoadjuvant mFOLFIRINOX followed by surgical resection and 6 cycles of adjuvant mFOLFIRINOX Comparator arm : surgical resection followed by 12 cycles of adjuvant mFOLFIRINOX Primary endpoint: 2-year overall survival rate by intention-to-treat
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
No arterial tumor contact (celiac asix, superior mesenteric artery, or common hepatic artery).
No tumor contact with the superior mesenteric vein or portal vein or ≤ 180°contact without vein contour irregularity.
Bone marrow function: WBC 3,000/mm3 or more or ANC 1,500/mm3 or more, platelet ≥ 100K/mm3
Liver function: Bilirubin ≤ 3 x upper normal limit (≤5.0 mg/dL), AST/ALT ≤ 5 x upper normal limit (<200 IU/L)
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Folfirinox
DrugThe primary aim of this trial was to investigate whether six cycles of preoperative mFOLFIRINOX followed by six cycles of postoperative mFOLFIRINOX improved the overall survival rate by intention-to-treat compared to surgery followed by 12 cycles of postoperative mFOLFIRINOX.
Treatment groups
609 Participants
are divided into 2 treatment groupsGroup A: Neoadjuvant FOLFIRINOXExperimental treatment 1 intervention
Group B: Upfront SurgeryActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
2-year survival rate
The primary objective of this trial is to investigate whether 6 cycles of preoperative mFOLFIRINOX - surgery - 6 cycles of postoperative mFOLFIRINOX improves overall survival by intention-to-treat compared to surgery followed by 12 cycles of postoperative mFOLFIRINOX.
Time frame
2 yearsSecondary outcomes
1
Overall survival
Defined as the time from the date of randomization to the date of death from any cause. Patients who were not reported dead at the time of analysis were censored on the last day they were known to be alive.
Time frame
5 years2
Disease free survival
Defined as the time between the date of randomization and the occurrence of distant metastases, locoregional progression, or death from any cause. Patients who were alive and free of these events at the last follow-up would be censored.
Time frame
3 years3
Resection rate
Referred to the proportion of patients who underwent curative resection
Time frame
3 years4
R0 resection rate
Referred to the proportion of patients with microscopically negative resection margins due to the pathological examinations after the surgery. In this case, R0 indicated that no tumor was observed within 0 mm from the margins of resection.
Time frame
3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Seoul National University Hospital
Lead sponsor
Seoul National University Bundang Hospital
Collaborator
SMG-SNU Boramae Medical Center
Collaborator
Gangnam Severance Hospital
Collaborator
Seoul St. Mary's Hospital
Collaborator
Source ClinicalTrials.gov