Efficacy of neoadjuvant FOLFIRINOX in resectable pancreatic cancer (NeoFOL-R): study protocol for an international, multicenter, prospective, randomized controlled trial
Abstract
Background Recent randomized controlled trials (RCTs) regarding the outcomes of neoadjuvant chemotherapy for patients with resectable pancreatic cancer (PC) reported inconsistent results. As the survival rate of FOLFIRINOX was found to be superior to that of gemcitabine, interest in the efficacy of neoadjuvant chemotherapy with FOLFIRINOX for resectable PC is growing. In this study, we aimed to investigate the efficacy of neoadjuvant FOLFIRINOX in patients with resectable PC. Methods This international (South Korea, Australia, and Taiwan), multicenter, phase 3, RCT will include 609 patients with resectable pancreatic ductal adenocarcinoma and ECOG performance 0–1. Resectable PC is defined as no arterial contact and no tumour contact with the superior mesenteric vein/portal vein or ≤ 180°contact without vein contour irregularity. Neoadjuvant FOLFIRINOX consisted of oxaliplatin (85 mg/m2), administered intravenously over 2 h, followed by leucovorin (400 mg/m2) over 2 h and irinotecan (180 mg/m2) over 90 min, administered concurrently. Subsequently, an intravenous bolus infusion of 5-FU (400 mg/m2) and a continuous infusion of 5-FU (2400 mg/m2) over 46 h, repeated every 2 weeks for 6 cycles. Adjuvant therapy with modified FOLFIRINOX (mFOLFIRINOX) included oxaliplatin (85 mg/m2), irinotecan (150 mg/m2), leucovorin (400 mg/m2), and fluorouracil (2400 mg/m2) over 46 h and repeated every 2 weeks, with six cycles in the neoadjuvant group and 12 cycles in the upfront surgery group.…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 609 participants or records.
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