Status:
COMPLETED
NEOadjuvant Gemcitabine/Oxaliplatin Plus Adjuvant Gemcitabine in Resectable PAncreatic Cancer
Lead Sponsor:
Institut Paoli-Calmettes
Conditions:
Pancreas Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 perf...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01521702
Start Date
December 1 2011
End Date
February 1 2015
Last Update
March 20 2015
Active Locations (1)
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1
Institut Paoli Calmettes
Marseille, France, 13009