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Effectiveness Assessment of Riluzole in the Prevention of Oxaliplatin-induced Peripheral Neuropathy.
Sponsor: UNICANCER
Summary
It is a phase II trial, randomized, parallel, double blind, multicenter, comparing riluzole versus placebo. The trial population is composed of patients ≥18 years old that have developed stage II/III colorectal cancer and are eligible for Simplified FOLFOX4 (6-12 cycles) adjuvant chemotherapy. The primary objective is to assess the preventive efficacy of riluzole on the severity of oxaliplatin-induced peripheral neuropathy during the Simplified FOLFOX4 adjuvant chemotherapy of stage II/III colorectal cancers.
Official title: Effectiveness Assessment of Riluzole in the Prevention of Oxaliplatin-induced Peripheral Neuropathy: A Phase II Randomized Study by UNICANCER With the Cooperation of AFSOS
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2020-10-28
Completion Date
2026-12-31
Last Updated
2026-05-20
Healthy Volunteers
No
Interventions
Riluzole
Riluzole during chemotherapy (oxaliplatin)
Placebo Oral Tablet
placebo
Locations (16)
ICO - Site Paul Papin
Angers, France
CH Beauvais
Beauvais, France
Centre François Baclesse
Caen, France
Hia Percy
Clamart, France
CHU de Clermont -Ferrand
Clermont-Ferrand, France
Clinique St Côme
Compiègne, France
GHPSO
Creil, France
Centre Georges François Leclerc
Dijon, France
CHU de Dijon
Dijon, France
CH Annecy-Genevois
Pringy, France
CHU de Reims
Reims, France
Institut Jean Godinot
Reims, France
ICO - Site René Gauducheau
Saint-Herblain, France
Hia Begin
Saint-Mandé, France
CHU de Saint-Etienne
Saint-Priest, France
Hôpital Foch
Suresnes, France