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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Institute of Clinical Cancer Research (IKF), UCT - University Cancer Center, Frankfurt, Germany
Frankfurt, Germany
median overall survival
Time frame: From date of randomization until the date of death from any cause assessed up to 24 months
median progression-free survival (PFS)
Time frame: From date of randomization until the date of first documented progression / relapse or date of death from any cause, whichever came first, assessed up to 24 months
perioperative morbidity and mortality
Time frame: 30 days after surgery
R0 resection rate
Time frame: 2 months after surgery
pathological complete remission
during surgery, paraffin embedded tissue is prepared for analysis which is analyzed for remission grading at the central pathology afterwards
Time frame: at surgery
adverse events (grade, number per patient) related to of G-CSF prophylaxis in the Folfirinox arm
Time frame: up to 40 weeks
prevalence of iron deficiency
Time frame: baseline, d1 of every cycle, end of treatment
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