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. 2023 Aug 7;23(1):728.
doi: 10.1186/s12885-023-11141-5.

Perioperative or adjuvant mFOLFIRINOX for resectable pancreatic cancer (PREOPANC-3): study protocol for a multicenter randomized controlled trial

J L van Dam  1 , E M M Verkolf  1 , E N Dekker  1 , B A Bonsing  2 , S O Bratlie  3 , L A A Brosens  4   5 , O R Busch  6   7 , L M J W van Driel  8 , C H J van Eijck  1 , S Feshtali  9 , P Ghorbani  10 , D J A de Groot  11 , J W B de Groot  12 , B C M Haberkorn  13 , I H de Hingh  14 , B van der Holt  15 , T M Karsten  16 , M B van der Kolk  17 , K J Labori  18 , M S L Liem  19 , O J L Loosveld  20 , I Q Molenaar  21 , M B Polée  22 , H C van Santvoort  21 , J de Vos-Geelen  23 , M L Wumkes  24 , G van Tienhoven  7   25 , M Y V Homs  26 , M G Besselink  6   7 , J W Wilmink  7   27 , B Groot Koerkamp  28 ; Dutch Pancreatic Cancer Group
Affiliations

Perioperative or adjuvant mFOLFIRINOX for resectable pancreatic cancer (PREOPANC-3): study protocol for a multicenter randomized controlled trial

J L van Dam et al. BMC Cancer. .

Abstract

Background: Surgical resection followed by adjuvant mFOLFIRINOX (5-fluorouracil with leucovorin, irinotecan, and oxaliplatin) is currently the standard of care for patients with resectable pancreatic cancer. The main concern regarding adjuvant chemotherapy is that only half of patients actually receive adjuvant treatment. Neoadjuvant chemotherapy, on the other hand, guarantees early systemic treatment and may increase chemotherapy use and thereby improve overall survival. Furthermore, it may prevent futile surgery in patients with rapidly progressive disease. However, some argue that neoadjuvant therapy delays surgery, which could lead to progression towards unresectable disease and thus offset the potential benefits. Comparison of perioperative (i.e., neoadjuvant and adjuvant) with (only) adjuvant administration of mFOLFIRINOX in a randomized controlled trial (RCT) is needed to determine the optimal approach.

Methods: This multicenter, phase 3, RCT will include 378 patients with resectable pancreatic ductal adenocarcinoma with a WHO performance status of 0 or 1. Patients are recruited from 20 Dutch centers and three centers in Norway and Sweden. Resectable pancreatic cancer is defined as no arterial contact and ≤ 90 degrees venous contact. Patients in the intervention arm are scheduled for 8 cycles of neoadjuvant mFOLFIRINOX followed by surgery and 4 cycles of adjuvant mFOLFIRINOX (2-week cycle of oxaliplatin 85 mg/m2, leucovorin 400 mg/m2, irinotecan 150 mg/m2 at day 1, followed by 46 h continuous infusion of 5-fluorouracil 2400 g/m2). Patients in the comparator arm start with surgery followed by 12 cycles of adjuvant mFOLFIRINOX. The primary outcome is overall survival by intention-to-treat. Secondary outcomes include progression-free survival, resection rate, quality of life, adverse events, and surgical complications. To detect a hazard ratio of 0.70 with 80% power, 252 events are needed. The number of events is expected to be reached after the inclusion of 378 patients in 36 months, with analysis planned 18 months after the last patient has been randomized.

Discussion: The multicenter PREOPANC-3 trial compares perioperative mFOLFIRINOX with adjuvant mFOLFIRINOX in patients with resectable pancreatic cancer.

Trial registration: Clinical Trials: NCT04927780. Registered June 16, 2021.

Keywords: Adjuvant therapy; Neoadjuvant therapy; Overall survival; Pancreatic cancer; Randomized controlled trial; mFOLFIRINOX.

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Conflict of interest statement

The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Treatment schedule
See this image and copyright information in PMC

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