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Type(s) of Cancer
Colorectal
Study Phase
Phase 3
Study Completion Date
2002
NCT00272051Uploaded 04-28-2015
Available for Download
PDS UID: Colorec_SanofiU_2002_137
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)
Provider Information
Provider Data DescriptionPrimary: 1)To compare the risk of occurrence of Grade 3-4 oxaliplatin-induced cumulative peripheral sensory neuropathy (PSN) relative to the cumulative dose of oxaliplatin in patients being treated with xaliproden by comparison to patients being treated with a placebo. 2) to demonstrate the absence of negative impact of xaliproden treatment on the FOLFOX4 regimen outcome, by demonstrating noninferiority in response rate (RR) for the treatment arm.Secondary: 1) To evaluate neurotoxicity in each arm. 2) to evaluate antitumoral efficacy for each of the 2 arms by looking at progression free survival (PFS) and overall survival (OS). 3) Document the safety profile of xaliproden
SponsorSanofi US Services Inc.
Data ProviderSanofi
Partial set or SubsetOriginal Data
Patients in dataset646
# of Patients Control322
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/f89v-3y46
CDISC Standardraw data
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryPurpose 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.
ConditionsMetastases
Colorectal Neoplasms
Colorectal Carcinoma
Intervention TypeDrug: SR57746A
Drug(s)N/A
Total Enrolled620
RandomizationRandomized
Blinding MethodDouble
Arms InterventionN/A
Secondary IDSR57746A
PubMed (PMID)31378656
30679026
Collaborator(s)N/A
Region(s)N/A
Age Range18 Years and older (Adult, Older Adult)
Files:
PROTOCOLsanofi_sr57746_efc4972_protocol_and_amendment_redacted.pdf
CRFsanofi_SR57746A_EFC4972_CRF_redacted.pdf
DATA DICTIONARYsanofi_SR57746A_EFC4972_data_definition.xls
DATA (COMPARATOR ARM)sanofi_sr57746A_efc4972_datasets_and readme.zip
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