Perioperative or adjuvant mFOLFIRINOX for resectable pancreatic cancer (PREOPANC-3): study protocol for a multicenter randomized controlled trial.
Humans
Irinotecan
/ therapeutic use
Oxaliplatin
/ therapeutic use
Leucovorin
/ therapeutic use
Antineoplastic Combined Chemotherapy Protocols
/ adverse effects
Pancreatic Neoplasms
/ drug therapy
Fluorouracil
/ therapeutic use
Neoadjuvant Therapy
/ methods
Chemotherapy, Adjuvant
Adjuvants, Immunologic
/ therapeutic use
Randomized Controlled Trials as Topic
Multicenter Studies as Topic
Pancreatic Neoplasms
Adjuvant therapy
Neoadjuvant therapy
Overall survival
Pancreatic cancer
Randomized controlled trial
mFOLFIRINOX
Journal
BMC cancer
ISSN: 1471-2407
Titre abrégé: BMC Cancer
Pays: England
ID NLM: 100967800
Informations de publication
Date de publication:
07 Aug 2023
07 Aug 2023
Historique:
received:
12
01
2023
accepted:
30
06
2023
medline:
9
8
2023
pubmed:
8
8
2023
entrez:
7
8
2023
Statut:
epublish
Résumé
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. 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/m The multicenter PREOPANC-3 trial compares perioperative mFOLFIRINOX with adjuvant mFOLFIRINOX in patients with resectable pancreatic cancer. Clinical Trials: NCT04927780. Registered June 16, 2021.
Sections du résumé
BACKGROUND
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
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/m
DISCUSSION
CONCLUSIONS
The multicenter PREOPANC-3 trial compares perioperative mFOLFIRINOX with adjuvant mFOLFIRINOX in patients with resectable pancreatic cancer.
TRIAL REGISTRATION
BACKGROUND
Clinical Trials: NCT04927780. Registered June 16, 2021.
Identifiants
pubmed: 37550634
doi: 10.1186/s12885-023-11141-5
pii: 10.1186/s12885-023-11141-5
pmc: PMC10405377
doi:
Substances chimiques
Irinotecan
7673326042
Oxaliplatin
04ZR38536J
Leucovorin
Q573I9DVLP
Fluorouracil
U3P01618RT
Adjuvants, Immunologic
0
Banques de données
ClinicalTrials.gov
['NCT04927780']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
728Informations de copyright
© 2023. BioMed Central Ltd., part of Springer Nature.
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