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

Study Description

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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 Design

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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

Arms and Interventions

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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.

Outcome Measures

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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,

Eligibility Criteria

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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

Contacts and Locations

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Locations

France
Institut Paoli Calmettes
Marseille, France, 13009

Sponsors and Collaborators

Institut Paoli-Calmettes

Investigators

Principal Investigator:	Jean-Luc RAOUL, MD	Institut Paoli-Calmettes

More Information

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Additional Information:

official web site of the sponsor 

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
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