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NeoFOL-R Trial (Perioperative Versus Adjuvnat FOLFIRINOX in Resectable Pancreatic Cancer)

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated November 27, 2024 (before its estimated December 2024 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Sep 2023 to Apr 1, 2023 · Eligibility criteria expanded, about 98 words · Secondary endpoints: 6 to 7 · 2 morev3 Show 5 more changesShow less
    • Start date changed from estimate of Sep 2023 to Apr 1, 2023
    • Eligibility criteria expanded, about 98 words
    • Secondary endpoints: 6 to 7
    • Site details revised at 2 of 2 sites
    • Collaborators reordered

    See this version in full on ClinicalTrials.gov ↗

  2. Start date: Mar 2023 to Sep 2023 Study sites: 0 to 2 · Eligibility criteria revised · Study title expanded, about 4 wordsv2 Show 3 more changesShow less
    • Study sites: 0 to 2
    • Eligibility criteria revised
    • Study title expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT05529940
Lead Sponsor Seoul National University Hospital
Collaborators: Seoul National University Bundang Hospital, SMG-SNU Boramae Medical Center, Gangnam Severance Hospital, Seoul St. Mary's Hospital
Conditions Resectable Pancreatic Cancer, Neoadjuvant Chemotherapy, Effects of Chemotherapy
Enrollment 609 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov