NEOadjuvant Gemcitabine/Oxaliplatin Plus Adjuvant Gemcitabine In Resectable PAncreatic Cancer

Study Overview

NEOadjuvant Gemcitabine/Oxaliplatin Plus Adjuvant Gemcitabine in Resectable PAncreatic Cancer

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.

N/A

Pancreas Cancer

DRUG: Neoadjuvant chemotherapy
PROCEDURE: surgery and Adjuvant chemotherapy

NEOPAC / IPC 2011-002

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2011-12-22	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2015-03-19
First Submitted that Met QC Criteria 2012-01-26	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2015-03-20
First Posted (ESTIMATED) 2012-01-31	Results First Posted N/A	Last Verified 2015-03

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: 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 proto	DRUG: Neoadjuvant chemotherapy four bi-weekly cycles of gemcitabine (intravenous infusion of 1000mg/m2 over 30 minutes) and oxaliplatin (intravenous infusion of 100mg/m2 over 2 hours,
ACTIVE_COMPARATOR: surgery surgery	PROCEDURE: surgery and Adjuvant chemotherapy surgery and Adjuvant chemotherapy must be started within eight weeks after surgery and is based on the standard regimen using six cycles of gemcitabine (Gem 1000mg/m2 over 30 minutes) on days 1, 8, 15 every 4 weeks.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: 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 proto

DRUG: Neoadjuvant chemotherapy

four bi-weekly cycles of gemcitabine (intravenous infusion of 1000mg/m2 over 30 minutes) and oxaliplatin (intravenous infusion of 100mg/m2 over 2 hours,

ACTIVE_COMPARATOR: surgery

surgery

PROCEDURE: surgery and Adjuvant chemotherapy

surgery and Adjuvant chemotherapy must be started within eight weeks after surgery and is based on the standard regimen using six cycles of gemcitabine (Gem 1000mg/m2 over 30 minutes) on days 1, 8, 15 every 4 weeks.

Primary Outcome Measures	Measure Description	Time Frame
progression-free survival	period from study inclusion until the date of recurrence or surgery (in case of unresectability at surgical exploration).	from date of randomization until date of progression, assessed up to 5 years

Secondary Outcome Measures	Measure Description	Time Frame
histology	histological response,	at 6 months
overall survival	time from date of inclusion to date of death	From date of randomization until date of death, assessed up to 5 years
complication	complication rates after surgery,	until 6 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Jean-Luc RAOUL, MD, Institut Paoli-Calmettes

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Caregivers

Clinical Trial Record