Adjuvant Gemcitabine Versus NEOadjuvant Gemcitabine/Oxaliplatin Plus Adjuvant Gemcitabine in Resectable PAncreatic Cancer: a Randomized Multicenter Phase III Study
Overview
- Phase
- Phase 3
- Intervention
- Neoadjuvant chemotherapy
- Conditions
- Pancreas Cancer
- Sponsor
- Institut Paoli-Calmettes
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- progression-free survival
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •resectable adenocarcinoma of the pancreatic head (requiring duodeno-pancreatectomy)
- •T1-3, Nx, M0 (UICC 6th version, 2002)
- •infiltration of the portal vein (\<180°) is not an exclusion criterion
- •cytologic or histologic confirmation of adenocarcinoma
- •age \>18 years
- •written informed consent
Exclusion Criteria
- •contraindication for Whipple procedure
- •an infiltration \>180° of the portal vein
- •abutment of the tumor to the superior mesenteric artery
- •infiltration of the superior mesenteric artery or the celiac trunk
- •chronic neuropathy \> grade 2
- •WHO performance score \>2
- •uncorrectable cholestasis (bilirubin \> 100mmol/l despite drainage attempts for more than four weeks prior to inclusion)
- •female patients in child bearing age not using adequate contraception (oral or subcutaneous contraceptives, intrauterine pessars (IUP), condoms)
- •pregnant or lactating women
- •mental or organic disorders which could interfere with giving informed consent or receiving treatments
Arms & Interventions
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).
Intervention: Neoadjuvant chemotherapy
surgery
surgery
Intervention: surgery and Adjuvant chemotherapy
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- histology(at 6 months)
- overall survival(From date of randomization until date of death, assessed up to 5 years)
- complication(until 6 months)