NEOadjuvant Gemcitabine/Oxaliplatin Plus Adjuvant Gemcitabine in Resectable PAncreatic Cancer

Study Overview
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Brief Summary
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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.

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

Conditions
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Pancreas Cancer

Intervention / Treatment
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* Drug: Neoadjuvant chemotherapy
* Procedure: surgery and Adjuvant chemotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neoadjuvant chemotherapy<br>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<br>* four bi-weekly cycles of gemcitabine (intravenous infusion of 1000mg/m2 over 30 minutes) and oxaliplatin (intravenous infusion of 100mg/m2 over 2 hours,<br>|
| Active Comparator: surgery<br>surgery | Procedure: surgery and Adjuvant chemotherapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| histology | histological response, | at 6 months | 
| overall survival | time from date of inclusion to date of death | From date of randomization until date of death, assessed up to 5 years | 
| complication | complication rates after surgery, | until 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenocarcinoma, pancreatic head