NEOadjuvant Gemcitabine/Oxaliplatin Plus Adjuvant Gemcitabine in Resectable PAncreatic Cancer
NCT ID: NCT01521702
Last Updated: 2015-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
2 participants
INTERVENTIONAL
2011-12-31
2015-02-28
Brief Summary
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This study will be performed in compliance with the study protocol, GCP (good clinical practice) and the applicable regulatory requirements.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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).
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,
surgery
surgery
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.
Interventions
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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,
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 Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Institut Paoli-Calmettes
OTHER
Responsible Party
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Principal Investigators
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Jean-Luc RAOUL, MD
Role: PRINCIPAL_INVESTIGATOR
Institut Paoli-Calmettes
Locations
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Institut Paoli Calmettes
Marseille, , France
Countries
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Related Links
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official web site of the sponsor
Other Identifiers
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NEOPAC / IPC 2011-002
Identifier Type: -
Identifier Source: org_study_id
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