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

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ClinicalTrials.gov Identifier: NCT01521702
Recruitment Status : Completed
First Posted : January 31, 2012
Last Update Posted : March 20, 2015
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Pancreas Cancer Drug: Neoadjuvant chemotherapy Procedure: surgery and Adjuvant chemotherapy Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : December 2011
Primary Completion Date : February 2015
Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 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,
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 :
  1. progression-free survival [ Time Frame: 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 :
  1. histology [ Time Frame: at 6 months ]
    histological response,

  2. overall survival [ Time Frame: From date of randomization until date of death, assessed up to 5 years ]
    time from date of inclusion to date of death

  3. complication [ Time Frame: until 6 months ]
    complication rates after surgery,



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01521702


Locations
France
Institut Paoli Calmettes
Marseille, France, 13009
Sponsors and Collaborators
Institut Paoli-Calmettes
Investigators
Principal Investigator: Jean-Luc RAOUL, MD Institut Paoli-Calmettes

Additional Information:
Responsible Party: Institut Paoli-Calmettes
ClinicalTrials.gov Identifier: NCT01521702     History of Changes
Other Study ID Numbers: NEOPAC / IPC 2011-002
First Posted: January 31, 2012    Key Record Dates
Last Update Posted: March 20, 2015
Last Verified: March 2015

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
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs