Evaluation of the Efficacy of Xaliproden (SR57746A) in Preventing the Neurotoxicity of Oxaliplatin / 5FU/LV Chemotherapy.
Status:
Completed
Trial end date:
2009-10-01
Target enrollment:
Participant gender:
Summary
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).