NEOadjuvant Gemcitabine/Oxaliplatin Plus Adjuvant Gemcitabine in Resectable PAncreatic Cancer (NEOPAC)
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.
|Pancreas Cancer||Drug: Neoadjuvant chemotherapy Procedure: surgery and Adjuvant chemotherapy||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Adjuvant Gemcitabine Versus NEOadjuvant Gemcitabine/Oxaliplatin Plus Adjuvant Gemcitabine in Resectable PAncreatic Cancer: a Randomized Multicenter Phase III Study|
- progression-free survival [ Time Frame: from date of randomization until date of progression, assessed up to 5 years ]period from study inclusion until the date of recurrence or surgery (in case of unresectability at surgical exploration).
- histology [ Time Frame: at 6 months ]histological response,
- overall survival [ Time Frame: From date of randomization until date of death, assessed up to 5 years ]time from date of inclusion to date of death
- complication [ Time Frame: until 6 months ]complication rates after surgery,
|Study Start Date:||December 2011|
|Study Completion Date:||February 2015|
|Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
Experimental: Neoadjuvant chemotherapy
After initial staging laparoscopy, Neoadjuvant chemotherapy consists of four bi-weekly cycles of gemcitabine (intravenous infusion of 1000mg/m2 over 30 minutes) and oxaliplatin (intravenous infusion of 100mg/m2 over 2 hours, modified from the Louvet protocol11).
Drug: Neoadjuvant chemotherapy
four bi-weekly cycles of gemcitabine (intravenous infusion of 1000mg/m2 over 30 minutes) and oxaliplatin (intravenous infusion of 100mg/m2 over 2 hours,
Active Comparator: surgery
Procedure: surgery and Adjuvant chemotherapy
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01521702
|Institut Paoli Calmettes|
|Marseille, France, 13009|
|Principal Investigator:||Jean-Luc RAOUL, MD||Institut Paoli-Calmettes|