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

This study is currently recruiting participants.

Verified March 2013 by Institut Paoli-Calmettes

Sponsor:

Information provided by (Responsible Party):

Institut Paoli-Calmettes

ClinicalTrials.gov Identifier:

NCT01521702

First received: December 22, 2011

Last updated: March 19, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

December 22, 2011

Last Updated Date

March 19, 2013

Start Date ^ICMJE

December 2011

Estimated Primary Completion Date

December 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

progression-free survival [ Time Frame: from date of randomization until date of progression, assessed up to 5 years ] [ Designated as safety issue: No ]

period from study inclusion until the date of recurrence or surgery (in case of unresectability at surgical exploration).

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01521702 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

histology [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
histological response,
overall survival [ Time Frame: From date of randomization until date of death, assessed up to 5 years ] [ Designated as safety issue: No ]
time from date of inclusion to date of death
complication [ Time Frame: until 6 months ] [ Designated as safety issue: Yes ]
complication rates after surgery,

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

NEOadjuvant Gemcitabine/Oxaliplatin Plus Adjuvant Gemcitabine in Resectable PAncreatic Cancer

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Pancreas Cancer

Intervention ^ICMJE

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,

Other Name: Neoadjuvant chemotherapy
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.

Other Name: surgery and Adjuvant chemotherapy

Study Arm (s)

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 protocol11).

Intervention: Drug: Neoadjuvant chemotherapy
Active Comparator: surgery
surgery

Intervention: Procedure: surgery and Adjuvant chemotherapy

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

310

Completion Date

Not Provided

Estimated Primary Completion Date

December 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Dominique GENRE, MD	33491223778	bec@marseille.fnclcc.fr
Contact: Agnès BOYER CHAMMARD, MD	33491223778	bec@marseille.fnclcc.fr

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01521702

Other Study ID Numbers ^ICMJE

NEOPAC / IPC 2011-002

Has Data Monitoring Committee

Responsible Party

Institut Paoli-Calmettes

Study Sponsor ^ICMJE

Institut Paoli-Calmettes

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Jean-Luc RAOUL, MD

Institut Paoli-Calmettes

Information Provided By

Institut Paoli-Calmettes

Verification Date

March 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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