Colorectal Neoplasms Clinical Trial
Official 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 Treated With Oxaliplatin / 5-FU/LV
Primary 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).
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
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