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Colorectal

A multicenter randomized double-blind placebo-controlled Phase 3 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)

Unique Data Set IDColorec_SanofiU_2002_137
DownloadableYes
SponsorSanofi US Services Inc.Data ProviderSanofiTotal Study Enrolled Patients646Comparator (Control) Arm Enrolled Patients322RandomizationYesClinicalTrial.gov IDNCT00272051ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/NCT00272051?term=efc4972&rank=1
Study PhaseClinical Study Phase IIIBlinding MethodDouble-BlindedType(s) of dataOnly comparator arm dataIntervention TypeDrug, Chemotherapy, PlaceboData Set TypeOther

Clinical Trial Title

A multicenter randomized double-blind placebo-controlled Phase 3 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)

Trial Summary and Conditions

Main diagnosis and criteria for inclusion: 1) Histologically or cytologically-proven adenocarcinoma of the colon or rectum. 2) metastatic disease not amenable to potentially curative treatment. 3) no prior chemotherapeutic regimen for metastatic disease. 4) disease free interval from end of adjuvant chemotherapy >6 months 5) no prior adjuvant chemotherapy with oxaliplatin. 6) at least 1 unidimensionally measurable lesion (RECIST) 7) no peripheral neuropathy 8) detectable sensory action potential (SAP) 9) age >=18 years, WHO Performance Status (PS): 0, 1, or 2; and adequate organnfunction. 10) signed written informed consent.

Data Summary

Datasets contain the 322 de-identified subjects assigned to the control arm. Demographic, baseline information, safety, efficacy datasets, medication, and dosing datasets were included amongst others. Source data is raw data.

Study Objectives

Primary: 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

Outcome Measures

See Study Objectives and for evaluating neurotoxicity in each arm look at: 1) incidence per patient and dose to onset of cumulative PSN. 2) incidence of dose-reduction, of dose-delay and oxaliplatin discontinuation due to cumulative PSN 3) time to recovery from Grade 3-4 cumulative PSN. 4) incidence of acute symptoms of PSN. 5) changes in nerve conduction studies (NCS). 6) changes in modified Norris scale (MNS) questionnaire score

Available Downloads:

To gain access to the data and analytic tools click here.

PROTOCOL: sanofi_sr57746_efc4972_protocol_and_amendment_redacted.pdf

CRF: sanofi_SR57746A_EFC4972_CRF_redacted.pdf

DATA DICTIONARY: sanofi_SR57746A_EFC4972_data_definition.xls

DATA (COMPARATOR ARM): sanofi_sr57746A_efc4972_datasets_and readme.zip