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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 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: October 30, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Pancreas Cancer
Drug: Neoadjuvant chemotherapy
Procedure: surgery and Adjuvant chemotherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Adjuvant Gemcitabine Versus NEOadjuvant Gemcitabine/Oxaliplatin Plus Adjuvant Gemcitabine in Resectable PAncreatic Cancer: a Randomized Multicenter Phase III Study

Resource links provided by NLM:


Further study details as provided by Institut Paoli-Calmettes:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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,


Estimated Enrollment: 310
Study Start Date: December 2011
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
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
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.
Other Name: surgery and Adjuvant chemotherapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01521702

Contacts
Contact: Dominique GENRE, MD 33491223778 drci.up@ipc.unicancer.fr
Contact: Agnès BOYER CHAMMARD, MD 33491223778 drci.up@ipc.unicancer.fr

Locations
France
Institut Paoli Calmettes Recruiting
Marseille, France, 13009
Contact: Jean-Luc RAOUL, MD    33491223778    drci.up@ipc.unicancer.fr   
Principal Investigator: Jean-Luc RAOUL, MD         
Sponsors and Collaborators
Institut Paoli-Calmettes
Investigators
Principal Investigator: Jean-Luc RAOUL, MD Institut Paoli-Calmettes
  More Information

Additional Information:
No publications provided

Responsible Party: Institut Paoli-Calmettes
ClinicalTrials.gov Identifier: NCT01521702     History of Changes
Other Study ID Numbers: NEOPAC / IPC 2011-002
Study First Received: December 22, 2011
Last Updated: October 30, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut Paoli-Calmettes:
adenocarcinoma
pancreatic head

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 19, 2014