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 
5, 6 September 2019
Short Title
Preopanc 2
Study site
www.dpcg.nl/projecten/preopanc-2
Principle Investigator
Drs. Judith de Vos
Investigator Maastro
Dr. J. Buijsen
Sponsor
ZonMW, Doelmatigheids Onderzoek, KWF
Trial registry
Objectives 

To 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.

Primary Endpoint 

Overall survival.

Secondary Endpoints 

To compare between the study arms:
• Chemotherapy rate • Chemotherapy completion rate
• Staging laparoscopy rate
• Laparoscopy yield
• Exploratory laparotomy rate
• Resection rate
• R0 resection rate
• Progression free survival (PFS)
• Locoregional failure free interval (LFFI)
• Distant metastases free interval (DMFI)
• Disease free survival (DFS)
• Locoregional recurrence free interval (LRFI)
• Postoperative complications
• Toxicity
• Quality of life years (QALYs)
• Indirect and direct medical and nonmedical costs
• Clinical response rate defined according to RECIST criteria
• Serum Cancer Antigen 19-9 (CA 19.9) and Carcino-Embryonal-Antigen (CEA) response
• Pathologic response