NEOadjuvant Gemcitabine/Oxaliplatin Plus Adjuvant Gemcitabine in Resectable PAncreatic Cancer (NEOPAC)
|ClinicalTrials.gov Identifier: NCT01521702|
Recruitment Status : Completed
First Posted : January 31, 2012
Last Update Posted : March 20, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Pancreas Cancer||Drug: Neoadjuvant chemotherapy Procedure: surgery and Adjuvant chemotherapy||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Adjuvant Gemcitabine Versus NEOadjuvant Gemcitabine/Oxaliplatin Plus Adjuvant Gemcitabine in Resectable PAncreatic Cancer: a Randomized Multicenter Phase III Study|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||February 2015|
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.
- 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,
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01521702
|Institut Paoli Calmettes|
|Marseille, France, 13009|
|Principal Investigator:||Jean-Luc RAOUL, MD||Institut Paoli-Calmettes|