NEOadjuvant Gemcitabine/Oxaliplatin Plus Adjuvant Gemcitabine in Resectable PAncreatic Cancer

Phase 3

Completed

• Conditions: Pancreas Cancer
• Interventions: Drug: Neoadjuvant chemotherapy; Procedure: surgery and Adjuvant chemotherapy

• Registration Number: NCT01521702
• Lead Sponsor: Institut Paoli-Calmettes

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-22
• Study First Submitted QC: 2012-01-26
• Study First Posted: 2012-01-31
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-19
• Last Update Posted: 2015-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neoadjuvant chemotherapy	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).
surgery	surgery and Adjuvant chemotherapy	surgery

Primary Outcome Measures

Name	Time	Method
progression-free survival	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 Outcome Measures

Name	Time	Method
histology	at 6 months	histological response,
overall survival	From date of randomization until date of death, assessed up to 5 years	time from date of inclusion to date of death
complication	until 6 months	complication rates after surgery,

Trial Locations

Locations (1)

Institut Paoli Calmettes; 🇫🇷 Marseille, France