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Sponsors and Collaborators: |
Centre Val d'Aurelle - Paul Lamarque Pfizer Sanofi-Aventis Chugai Pharmaceutical |
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Information provided by: | Centre Val d'Aurelle - Paul Lamarque |
ClinicalTrials.gov Identifier: | NCT00208260 |
Randomized, open label, multicentre phase II trial followed by phase III comparing overall survival after having selected the best experimental arm.
Condition | Intervention | Phase |
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Colorectal Cancer Liver Metastases Chemotherapy |
Drug: FOLFIRI Drug: FOLFOX-4 Drug: FOLFIRI-HD Drug: FOLFOX-7 Drug: FOLFIRINOX |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Randomized Phase II Trial Followed by Phase III Trial With Molecular Biology Study, Comparing a Standard bi-Therapy vs 3 Arms of Intensified Chemotherapy in Patients With Unresectable or Not Optimally Resectable Colorectal Cancer Liver Metastases. |
Enrollment: | 124 |
Study Start Date: | April 2004 |
Study Completion Date: | August 2007 |
Arms | Assigned Interventions |
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A: Active Comparator
FOLFIRI
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Drug: FOLFIRI
FOLFIRI : Irinotecan : 180 mg/m² 90 min continuous perfusion during levorin d1 every 2 weeks
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B: Active Comparator
FOLFOX-4
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Drug: FOLFOX-4
FOLFOX 4 : Oxaliplatine : 85 mg/m² 2h continuous perfusion during levorin d1 every 2weeks
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C: Experimental
FOLFIRI-HD
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Drug: FOLFIRI-HD
High Dose FOLFIRI : Irinotecan : 260 mg/m² in 90min continuous perfusion during levorin d1 every 2 weeks
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D: Experimental
FOLFOX-7
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Drug: FOLFOX-7
FOLFOX 7 : Oxaliplatine : 130 mg/m² in 2h continuous perfusion during levorin d1 every 2 weeks
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E: Experimental
FOLFIRINOX
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Drug: FOLFIRINOX
FOLFIRINOX : Oxaliplatine : 85 mg/m² 2h continuous perfusion followed by 1H rest followed by 90 min continuous perfusion of irinotecan : 180 mg/m² during levorin d1 every 2 weeks
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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France | |
CRLC Val d'Aurelle | |
MONTPELLIER, France, 34298 |
Principal Investigator: | Marc YCHOU, MD, PhD | CRLC Val d'Aurelle |
Study Chair: | Michel RIVOIRE, MD | CRLC Leon Berard - Lyon |
Study ID Numbers: | METHEP/2004/22 |
Study First Received: | September 13, 2005 |
Last Updated: | December 13, 2007 |
ClinicalTrials.gov Identifier: | NCT00208260 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Liver Diseases Digestive System Neoplasms Gastrointestinal Diseases Irinotecan Colonic Diseases Liver neoplasms Intestinal Diseases Rectal Diseases |
Intestinal Neoplasms Liver Neoplasms Oxaliplatin Digestive System Diseases Neoplasm Metastasis Gastrointestinal Neoplasms Colorectal Neoplasms |
Neoplastic Processes Neoplasms Pathologic Processes Neoplasms by Site |