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
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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 |
Actual Primary Completion Date : | February 2015 |
Actual Study Completion Date : | February 2015 |

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).
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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,
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Active Comparator: surgery
surgery
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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.
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- 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).
- histology [ Time Frame: at 6 months ]histological response,
- 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
- 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 |
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

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
France | |
Institut Paoli Calmettes | |
Marseille, France, 13009 |
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 |