Comparing Irinotecan and 5 FU/FA To 5-FU/FA After Resection Of Liver Metastases For Colorectal Cancer
NCT ID: NCT00143403
Last Updated: 2010-09-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
321 participants
INTERVENTIONAL
2001-12-31
2009-09-30
Brief Summary
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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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1
Irinotecan + 5 FU + folinic acid
irinotecan 180 mg/m2 folinic acid 400 mg/m2 (DL) followed by 5 FU bolus 400 mg/m2 5 FU continuous infusion (2400 mg/m2 over 46 hours) every 2 weeks
2
Folinic Acid + 5 FU
folinic acid 400 mg/m2(DL) followed by bolus 5 FU 400mg/m2 5 FU continuous infusion (2400 mg/m2 over 46 hours) every 2 weeks
Interventions
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Irinotecan + 5 FU + folinic acid
irinotecan 180 mg/m2 folinic acid 400 mg/m2 (DL) followed by 5 FU bolus 400 mg/m2 5 FU continuous infusion (2400 mg/m2 over 46 hours) every 2 weeks
Folinic Acid + 5 FU
folinic acid 400 mg/m2(DL) followed by bolus 5 FU 400mg/m2 5 FU continuous infusion (2400 mg/m2 over 46 hours) every 2 weeks
Eligibility Criteria
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Inclusion Criteria
* Complete surgical resection (R0) of the liver metastasis(es) within a minimum of 3 weeks, and a maximum of 8 weeks prior to the first study treatment infusion.
* Exclusively hepatic metastasis (es) : absence of bone, lung and brain metastases.
Exclusion Criteria
* Prior radiofrequency ablation or cryoablation Incomplete surgical resection of liver metastasis (es).
* Prior chemotherapy for metastatic disease.
18 Years
75 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Pfizer Inc
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Ghent, , Belgium
Pfizer Investigational Site
Roeselare, , Belgium
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Copenhagen, , Denmark
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Herlev, , Denmark
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Odense, , Denmark
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Amiens, , France
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Avignon, , France
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Boulogne-Billancourt, , France
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Clermont-Ferand Cedex 1, , France
Pfizer Investigational Site
Colmar, , France
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Grenoble, , France
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Marseille, , France
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Marseille, , France
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Marseille, , France
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Montpellier, , France
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Montpellier, , France
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Nice, , France
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Nîmes, , France
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Rennes, , France
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Strasbourg, , France
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Toulouse, , France
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Cottbus, , Germany
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Dessau, , Germany
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Erlangen, , Germany
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Hamburg, , Germany
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Leipzig, , Germany
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Magdeburg, , Germany
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Magdeburg, , Germany
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Mainz, , Germany
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Oldenburg, , Germany
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Regensburg, , Germany
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Tübingen, , Germany
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Hong Kong, , Hong Kong
Pfizer Investigational Site
Haifa, , Israel
Pfizer Investigational Site
Petah Tikva, , Israel
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Rehovot, , Israel
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Tel Aviv, , Israel
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Tel Litwinsky, , Israel
Pfizer Investigational Site
Carpi, Modena, Italy
Pfizer Investigational Site
Brescia, , Italy
Pfizer Investigational Site
Latisana, UD, , Italy
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Padua, , Italy
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Parma, , Italy
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Piacenza, , Italy
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Reggio Emilia, , Italy
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Rozzano (Mi), , Italy
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Porto, , Portugal
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Panorama, Cape Town, South Africa
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Daegu, , South Korea
Pfizer Investigational Site
Goyang, , South Korea
Pfizer Investigational Site
Seoul, , South Korea
Pfizer Investigational Site
Seoul, , South Korea
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Seoul, , South Korea
Pfizer Investigational Site
Barcelona, Barcelona, Spain
Pfizer Investigational Site
L'Hospitalet de Llobregat, Barcelona, Spain
Pfizer Investigational Site
Santander, Cantabria, Spain
Pfizer Investigational Site
Madrid, Madrid, Spain
Pfizer Investigational Site
Seville, Sevilla, Spain
Pfizer Investigational Site
Gothenburg, , Sweden
Pfizer Investigational Site
Bern, , Switzerland
Pfizer Investigational Site
Taoyuan District, , Taiwan
Pfizer Investigational Site
Donetsk, Ukraine, Ukraine
Pfizer Investigational Site
Kiev, , Ukraine
Pfizer Investigational Site
London, , United Kingdom
Pfizer Investigational Site
Southampton, , United Kingdom
Pfizer Investigational Site
Surrey, , United Kingdom
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A5961076
Identifier Type: -
Identifier Source: secondary_id
CPT-GMA-301
Identifier Type: -
Identifier Source: org_study_id