Cancer types
  • Digestive tract
Title of study
The (cost)effectiveness of neoadjuvant folfirinox versus neoadjuvant gemcitabine based chemoradiotherapy and adjuvant gemcitabine for (borderline) resectable pancreatic cancer
Version Number
Approval Date 
3, 24 March 2018
Short Title
Preopanc 2
Study site
Principle Investigator
Dr. B. Groot Koerkamp
Investigator Maastro
Dr. J. Buijsen
Sponsor
ZonMW, Doelmatigheids Onderzoek, KWF
WHO Trial Registry
DUCG
ClinicalTrials.gov
Objectives 

• Investigate whether neoadjuvant chemotherapy with FOLFIRINOX (a combination of 5-fluorouracil, irinotecan, oxaliplatin, and leucovorin) improves overall survival compared to neoadjuvant gemcitabine based chemoradiotherapy with adjuvant gemcitabine in patients with (borderline) resectable pancreatic ductal adenocarcinoma
• Secondary Objective(s): To compare between the study arms: • Chemotherapy rate, defined as the percentage of eligible randomized patients who received at least one cycle of chemotherapy; • Chemotherapy completion rate, defined as the percentage of eligible randomized patients who completed all cycles of scheduled chemotherapy; • Staging laparoscopy rate, defined as the percentage of eligible randomized patients that actually underwent a staging laparoscopy, regardless whether a laparotomy or resection was performed

Primary Endpoint 

To determine whether neoadjuvant FOLFIRINOX followed by surgery improves overall survival compared to neoadjuvant gemcitabine based chemoradiotherapy followed by surgery and adjuvant gemcitabine in patients with (borderline) resectable pancreatic cancer in an intention-to-treat setting

Secondary Endpoints