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Type(s) of Cancer
Colorectal
Study Phase
Phase 3
Study Completion Date
October 2009
NCT00305188Uploaded 04-28-2015
Available for Download
PDS UID: Colorec_SanofiU_2005_136
A Multicenter, Randomized Double-blind Placebo Controlled Phase III Study of the Efficacy of Xaliproden in Preventing the Neurotoxicity of Oxaliplatin in First-line Treatment of Patients With Metastatic Colorectal Cancer Treated With Oxaliplatin / 5-FU/LV
Provider Information
Provider Data DescriptionPrimary objective is to compare the risk of occurrence of Grade3-4 oxaliplatin-induced cumulative peripheral sensory neuropathy (PSN). Main secondary objective (chemotherapy efficacy): To compare the Response Rate (RR) between the control arm A and the experimental arm B in order to ensure that the efficacy of the chemotherapy is not compromised by the addition of xaliproden (non-inferiority). Other secondary objectives (neurotoxicity for each arm): duration of oxaliplatin-induced PSN (Grades 2-4), overall incidence of PSN during treatment by patient and by Grades (1-4), time and dose to onset of PSN (Grades 1-4), incidence of dose-reduction and dose-delay due to PSN, incidence of oxaliplatin treatment discontinuation due to PSN, change in nerve conduction studies (NCS). Chemotherapy efficacy objectives to compare: progression free survival (PFS) and overall survival (OS). Safety profile other than PSN will also be compared.
SponsorSanofi US Services Inc.
Data ProviderSanofi
Partial set or SubsetOriginal Data
Patients in dataset875
# of Patients Control434
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/rjk2-d633
CDISC Standardraw data
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryPrimary Objective : Compare the risk of occurrence of Grade3-4 cumulative peripheral sensory neuropathy (PSN) relative to cumulative dose of oxaliplatin between treatment group and placebo group. Main Secondary Objective : Compare the response rate (RR) between treatment group and placebo group in order to ensure that the efficacy of the chemotherapy is not compromised by the addition of xaliproden to the chemotherapeutic regimen. Other Secondary Objectives : study of the neurotoxicity parameters (Duration of oxaliplatin-induced PSN (G2,3,4); overall incidence of PSN during treatment; dose of onset of PSN ; incidence of dose-reduction and dose delay due to PSN; incidence of oxaliplatin treatment discontinuation due to PSN; change in Nerve Conduction Studies (NCS)) ; study of the safety profile (other than PSN) ; study of the chemotherapy efficacy (progression free survival, overall survival).
ConditionsMetastases
Colorectal Neoplasms
Colorectal Carcinoma
Intervention TypeDrug: Xaliproden (SR57746A)
Drug: Placebo
Drug: Oxaliplatin
Drug: 5-Fluorouracil
Drug: Leucovorin
Drug(s)Drug: Xaliproden (SR57746A)
Drug: Oxaliplatin
Drug: 5-Fluorouracil
Drug: Leucovorin
Drug: Placebo
Total Enrolled879
RandomizationRandomized
Blinding MethodTriple
Arms InterventionXaliproden (SR57746A) - Experimental
Placebo - Placebo Comparator
Secondary IDEUDRACT : 2005-002570-30
PubMed (PMID)31378656
30679026
Collaborator(s)N/A
Region(s)United States
Argentina
Australia
Brazil
Canada
Chile
Germany
Hungary
Italy
Poland
Portugal
Spain
United Kingdom
Age Range18 Years and older (Adult, Older Adult)
Files:
PROTOCOLsanofi_SR57746A_EFC5505_protocol_and_amendments_redacted.pdf
CRFsanofi_SR57746A_efc5505_crf_redacted.pdf
DATA DICTIONARYsanofi_SR57746A_EFC5505_data_definition.xls
DATA (COMPARATOR ARM)sanofi_sr57746A_efc5505_datasets_and readme.zip
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