Abstract
Background: The recent Dutch PREOPANC-1 study demonstrated that neoadjuvant gemcitabine based chemoradiotherapy (CRT) followed by adjuvant gemcitabine has a superior radical resection rate and survival outcomes compared to upfront resection in patients with (borderline) resectable pancreatic cancer ((B)RPC). Potentially, neoadjuvant FOLFIRINOX could further improve these Results. The PREOPANC-2 study aims to investigate whether neoadjuvant chemotherapy with FOLFIRINOX improves overall survival compared to neoadjuvant gemcitabine based chemoradiotherapy and adjuvant chemotherapy in (B)RPC patients. Material & Methods: This multicenter randomized controlled trial (RCT) includes patients with pathologically proven (B)RPC and a WHO performance score 0 or 1. Resectability is defined as ≤90 degrees arterial and ≤270 degrees venous and involvement. Patients are randomized to receive 8 cycles of neoadjuvant FOLFIRINOX chemotherapy (arm A), or 3 cycles of neoadjuvant gemcitabine with hypofractionated radiotherapy (36 Gy in 15 fractions) added during the second cycle, followed by surgery and adjuvant 4 cycles of gemcitabine (arm B). The primary endpoint is overall survival by intention-to-treat. Secondary endpoints include progression- and disease-free survival, quality of life, and (R0) resection rate. Furthermore, a variety of circulating biomarkers including ctDNA, miRNA, tumor-educated platelets, immune profiling and proteomics will be collected at five sampling moments during neoadjuvant and perioperative treatment. 252 events are needed for a power of 80% to find 7 months difference in overall survival. Total sample size is 368 patients, with an accrual period of 3 years and 1.5 year of follow-up after last inclusion. Results: Ten out of 18 DPCG centers have started accruing patients, and 33 (9%) patients have been randomized. Most high-volume centers have started, with a current accrual rate of 5 - 10 patients per month. Biomarkers have been collected from >90% of sampling moments. Conclusion: Neoadjuvant FOLFIRINOX is a promising treatment for (B)RPC patients. The PREOPANC-2 evaluates its effectiveness in an RCT.
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