NEOadjuvant Gemcitabine/Oxaliplatin Plus Adjuvant Gemcitabine in Resectable PAncreatic Cancer

Pancreas Cancer Clinical Trial

— NEOPAC  

Official title:

Adjuvant Gemcitabine Versus NEOadjuvant Gemcitabine/Oxaliplatin Plus Adjuvant Gemcitabine in Resectable PAncreatic Cancer: a Randomized Multicenter Phase III Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01521702
• Other study ID #: NEOPAC / IPC 2011-002
• Status: Completed
• Phase: Phase 3
• First received: December 22, 2011
• Last updated: March 19, 2015
• Start date: December 2011
• Est. completion date: February 2015

Study information

• Verified date: March 2015
• Source: Institut Paoli-Calmettes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreas Cancer
• Pancreatic Neoplasms

Intervention

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,

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.

Locations

Country	Name	City	State
France	Institut Paoli Calmettes	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression-free survival	period from study inclusion until the date of recurrence or surgery (in case of unresectability at surgical exploration).	from date of randomization until date of progression, assessed up to 5 years	No
Secondary	histology	histological response,	at 6 months	No
Secondary	overall survival	time from date of inclusion to date of death	From date of randomization until date of death, assessed up to 5 years	No
Secondary	complication	complication rates after surgery,	until 6 months	Yes

External Links

•   official web site of the sponsor