NEOadjuvant Gemcitabine/Oxaliplatin Plus Adjuvant Gemcitabine in Resectable PAncreatic Cancer (NEOPAC)

Institut Paoli-Calmettes

Status and phase: Completed; Phase 3

Conditions: Pancreas Cancer

Treatments: Procedure: surgery and Adjuvant chemotherapy; Drug: Neoadjuvant chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01521702

NEOPAC / IPC 2011-002

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2 participants in 2 patient groups

Neoadjuvant chemotherapy

Experimental group

Description:

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).

Treatment:

Drug: Neoadjuvant chemotherapy

surgery

Active Comparator group

Description:

surgery

Treatment:

Procedure: surgery and Adjuvant chemotherapy