The aim of this study is to test the additional value of neoadjuvant chemotherapy to the standard treatment for resectable pancreatic cancer (surgery + adjuvant chemotherapy). This study will be performed in compliance with the study protocol, GCP (good clinical practice) and the applicable regulatory requirements.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2
four bi-weekly cycles of gemcitabine (intravenous infusion of 1000mg/m2 over 30 minutes) and oxaliplatin (intravenous infusion of 100mg/m2 over 2 hours,
surgery and Adjuvant chemotherapy must be started within eight weeks after surgery and is based on the standard regimen using six cycles of gemcitabine (Gem 1000mg/m2 over 30 minutes) on days 1, 8, 15 every 4 weeks.
Institut Paoli Calmettes
Marseille, France
progression-free survival
period from study inclusion until the date of recurrence or surgery (in case of unresectability at surgical exploration).
Time frame: from date of randomization until date of progression, assessed up to 5 years
histology
histological response,
Time frame: at 6 months
overall survival
time from date of inclusion to date of death
Time frame: From date of randomization until date of death, assessed up to 5 years
complication
complication rates after surgery,
Time frame: until 6 months
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