NEOadjuvant Gemcitabine/Oxaliplatin Plus Adjuvant Gemcitabine in Resectable PAncreatic Cancer

Adjuvant Gemcitabine Versus NEOadjuvant Gemcitabine/Oxaliplatin Plus Adjuvant Gemcitabine in Resectable PAncreatic Cancer: a Randomized Multicenter Phase III Study

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.

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
• Second malignancy diagnosed within the past 5 years, except non-melanomatous skin cancer or non-invasive cervical cancer
• percutaneous biopsy of the primary tumor