NEOadjuvant Gemcitabine/Oxaliplatin Plus Adjuvant Gemcitabine in Resectable PAncreatic Cancer - Full Text View

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:

MedlinePlus related topics: Pancreatic Cancer

Drug Information available for: Oxaliplatin Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

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,


Enrollment:	2
Study Start Date:	December 2011
Study Completion Date:	February 2015
Primary Completion Date:	February 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,
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.

Eligibility


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

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

Additional Information:

official web site of the sponsor This link exits the ClinicalTrials.gov site


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:	March 19, 2015
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 Antineoplastic Agents Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2016

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