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Colorectal

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 (MCRC) treated with oxaliplatin/5-FU/LV

Unique Data Set IDColorec_SanofiU_2005_136
DownloadableYes
SponsorSanofi US Services Inc.Data ProviderSanofiTotal Study Enrolled Patients875Comparator (Control) Arm Enrolled Patients434RandomizationYesClinicalTrial.gov IDNCT00305188ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/NCT00305188?term=efc5505&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 III study of the efficacy of xaliproden in preventing the neurotoxicity of oxaliplatin in first-line treatment of patients with metastatic colorectal cancer (MCRC) treated with oxaliplatin/5-FU/LV

Trial Summary and Conditions

Control arm A: oxaliplatin + 5-FU/LV + placebo. Experimental arm B: oxaliplatin + 5-FU/LV + xaliproden. Diagnosis and main criteria for inclusion: 1) Age >= 18 years. 2) WHO performance status : 0 or 1. 3) Histologically or cytologically-proven metastatic cancer of the colon or rectum; metastatic disease not curable by surgery or amenable to radiation therapy with curative intent. 4) Measurable disease: at least one unidimensionally measurable lesion with a diameter >= 20 mm using conventional computerized tomography (CT) or magnetic resonance imaging (MRI) scans or >= 10 mm using spiral CT scans. 5) Prior adjuvant chemotherapy with 5-FU/LV, with 5-FU/levamizole, with irinotecan/5-FU/LV, with capecitabine allowed provided disease-free interval from end of the adjuvant therapy > 6 months, with oxaliplatin/5-FU/LV provided the progression free interval from end of adjuvant therapy > 12 months. 6) No PSN > grade 1.

Data Summary

Datasets contain the 434 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 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.

Outcome Measures

See Study Objectives

Available Downloads:

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

PROTOCOL: sanofi_SR57746A_EFC5505_protocol_and_amendments_redacted.pdf

CRF: sanofi_SR57746A_efc5505_crf_redacted.pdf

DATA DICTIONARY: sanofi_SR57746A_EFC5505_data_definition.xls

DATA (COMPARATOR ARM): sanofi_sr57746A_efc5505_datasets_and readme.zip