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

Primary Purpose

Pancreas Cancer

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Neoadjuvant chemotherapy
surgery and Adjuvant chemotherapy
Sponsored by
Institut Paoli-Calmettes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreas Cancer focused on measuring adenocarcinoma, pancreatic head

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institut Paoli Calmettes

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Neoadjuvant chemotherapy

surgery

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

histology
histological response,
overall survival
time from date of inclusion to date of death
complication
complication rates after surgery,

Full Information

First Posted
December 22, 2011
Last Updated
March 19, 2015
Sponsor
Institut Paoli-Calmettes
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1. Study Identification

Unique Protocol Identification Number
NCT01521702
Brief Title
NEOadjuvant Gemcitabine/Oxaliplatin Plus Adjuvant Gemcitabine in Resectable PAncreatic Cancer
Acronym
NEOPAC
Official Title
Adjuvant Gemcitabine Versus NEOadjuvant Gemcitabine/Oxaliplatin Plus Adjuvant Gemcitabine in Resectable PAncreatic Cancer: a Randomized Multicenter Phase III Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Paoli-Calmettes

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreas Cancer
Keywords
adenocarcinoma, pancreatic head

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neoadjuvant chemotherapy
Arm Type
Experimental
Arm Description
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).
Arm Title
surgery
Arm Type
Active Comparator
Arm Description
surgery
Intervention Type
Drug
Intervention Name(s)
Neoadjuvant chemotherapy
Intervention Description
four bi-weekly cycles of gemcitabine (intravenous infusion of 1000mg/m2 over 30 minutes) and oxaliplatin (intravenous infusion of 100mg/m2 over 2 hours,
Intervention Type
Procedure
Intervention Name(s)
surgery and Adjuvant chemotherapy
Intervention Description
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 Measure Information:
Title
progression-free survival
Description
period from study inclusion until the date of recurrence or surgery (in case of unresectability at surgical exploration).
Time Frame
from date of randomization until date of progression, assessed up to 5 years
Secondary Outcome Measure Information:
Title
histology
Description
histological response,
Time Frame
at 6 months
Title
overall survival
Description
time from date of inclusion to date of death
Time Frame
From date of randomization until date of death, assessed up to 5 years
Title
complication
Description
complication rates after surgery,
Time Frame
until 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Luc RAOUL, MD
Organizational Affiliation
Institut Paoli-Calmettes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Paoli Calmettes
City
Marseille
ZIP/Postal Code
13009
Country
France

12. IPD Sharing Statement

Links:
URL
http://www.institutpaolicalmettes.fr
Description
official web site of the sponsor

Learn more about this trial

NEOadjuvant Gemcitabine/Oxaliplatin Plus Adjuvant Gemcitabine in Resectable PAncreatic Cancer

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