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SUSPENDED
NCT03722680
PHASE2

Effectiveness Assessment of Riluzole in the Prevention of Oxaliplatin-induced Peripheral Neuropathy.

Sponsor: UNICANCER

View on ClinicalTrials.gov

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

DRUG

Riluzole

Riluzole during chemotherapy (oxaliplatin)

DRUG

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