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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00272051 |
Purpose of the trial is to evaluate the efficacy of Xaliproden in reducing the neurotoxicity of the Oxaliplatin and 5-FU/LV chemotherapy, in patients with metastatic colorectal carcinomaPrimary objectives : Compare the risk of occurence of grade 3-4 peripheral sensory neuropathy relative to the cumulative dose of Oxaliplatin between treatment group and placebo group ; Compare the response rate between treatment group and placebo group.Secondary objectives : neurotoxicity parameters (overall incidence, time and dose to onset, time to recovery, change in the sensory action potentials) ; antitumoral efficacy (progression-free survival, overall survival) ; safety profile.
Condition | Intervention | Phase |
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Metastases Colorectal Neoplasms Colorectal Carcinoma |
Drug: SR57746A |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Multicenter Randomized Dble-Blind Placebo Controlled Phase III Study of the Efficacy of Xaliproden in Reducing the Neurotoxicity of the Oxaliplatin and 5-FU/LV Combination in First-Line Treatment of Patients With Metastatic Colorectal Carcinoma(MCRC) |
Estimated Enrollment: | 620 |
Study Start Date: | July 2002 |
Estimated Study Completion Date: | May 2004 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | EFC4972, SR57746A |
Study First Received: | January 3, 2006 |
Last Updated: | September 11, 2006 |
ClinicalTrials.gov Identifier: | NCT00272051 History of Changes |
Health Authority: | United Kingdom: National Health Service |
Neurotoxicity syndromes Paresthesia Oxaliplatin Xaliproden |
Digestive System Neoplasms Neurotoxicity Syndromes Gastrointestinal Diseases Colonic Diseases Poisoning Disorders of Environmental Origin Intestinal Diseases Rectal Diseases Intestinal Neoplasms |
Carcinoma Oxaliplatin Digestive System Diseases Fluorouracil Paresthesia Neoplasm Metastasis Gastrointestinal Neoplasms Colorectal Neoplasms Neoplasms, Glandular and Epithelial |
Neurotoxicity Syndromes Gastrointestinal Diseases Antineoplastic Agents Colonic Diseases Disorders of Environmental Origin Rectal Diseases Neoplastic Processes Oxaliplatin Neoplasms by Site Pathologic Processes Therapeutic Uses Neoplasm Metastasis Digestive System Neoplasms |
Neoplasms by Histologic Type Nervous System Diseases Poisoning Intestinal Diseases Intestinal Neoplasms Pharmacologic Actions Carcinoma Neoplasms Digestive System Diseases Gastrointestinal Neoplasms Colorectal Neoplasms Neoplasms, Glandular and Epithelial |