Resectable Prancreas Carcinoma Clinical Trial
Official title:
Randomized Multicenter Phase II/III Study With Adjuvant Gemcitabine Versus Neoadjuvant/Adjuvant FOLFIRINOX in Resectable Pancreatic Cancer
In this multicenter study, patients with resectable pancreatic carcinoma will be treated with
(a) surgery followed by 6 cycles gemcitabine or (b) 4-6 cycles FOLFIRINOX followed by surgery
followed by 4-6 cycles FOLFIRINOX.
The overall survival between both therapies will be compared as well as other parameters.
This is a phase II/III randomized multicenter study. Patients with resectable pancreatic
carcinoma will be randomized in Arm A (surgery plus adjuvant gemcitabine, 6 cycles) or Arm B
(4-6 cycles FOLFIRINOX neoadjuvant, 4-6 cycles FOLFIRINOX adjuvant).
Primary endpoint is the overall survival, secondary endpoints are progression-free survival,
perioperative morbidity and mortality, rate of R0 resections, tolerability and feasibility of
neoadjuvant FOLFIRINOX and others.
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