NEOadjuvant Gemcitabine/Oxaliplatin Plus Adjuvant Gemcitabine in Resectable PAncreatic Cancer

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut Paoli-Calmettes
• Treatments: Gemcitabine; Oxaliplatin

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

• Second malignancy diagnosed within the past 5 years, except non-melanomatous skin cancer or non-invasive cervical cancer

• percutaneous biopsy of the primary tumor