Informations générales (source: ClinicalTrials.gov)
Effectiveness Assessment of Riluzole in the Prevention of Oxaliplatin-induced Peripheral Neuropathy: A Phase II Randomized Study by UNICANCER With the Cooperation of AFSOS (RILUZOX-01)
Interventional
Phase 2
UNICANCER (Voir sur ClinicalTrials)
octobre 2020
décembre 2025
04 mai 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FOCH | Asmahane BENMAZIANE TEILLET | 05/05/2025 07:12:02 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| HIA BEGIN | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre François Baclesse - Caen - France | Contact (sur clinicalTrials) | ||||
| Centre Georges François Leclerc - Dijon - France | Contact (sur clinicalTrials) | ||||
| CH Annecy-Genevois - Pringy - France | Contact (sur clinicalTrials) | ||||
| CH Beauvais - Beauvais - France | Contact (sur clinicalTrials) | ||||
| CHU de Clermont -Ferrand - Clermont-Ferrand - France | Contact (sur clinicalTrials) | ||||
| CHU de Dijon - Dijon - France | Contact (sur clinicalTrials) | ||||
| CHU de Reims - Reims - France | Contact (sur clinicalTrials) | ||||
| CHU de Saint-Etienne - Saint-Priest - France | Contact (sur clinicalTrials) | ||||
| Clinique St Côme - Compiègne - France | Contact (sur clinicalTrials) | ||||
| GHPSO - Creil - France | Contact (sur clinicalTrials) | ||||
| Hia Percy - Clamart - France | Contact (sur clinicalTrials) | ||||
| Hôpital Foch - Suresnes - France | Contact (sur clinicalTrials) | ||||
| ICO - Site Paul Papin - Angers - France | Contact (sur clinicalTrials) | ||||
| ICO - Site René Gauducheau - Saint-Herblain - France | Contact (sur clinicalTrials) | ||||
| Institut Jean Godinot - Reims - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
1. Patients aged ≥ 18 years old,
2. Eligible patient starting adjuvant oxaliplatin-based chemotherapy (6-12 cycles,
Simplified FOLFOX4) for stage II/III colorectal cancer,
3. Histological or cytological confirmation of colorectal cancer,
4. Performance status (ECOG) ≤2,
5. Normal hematological function (ANC ≥1.5 x 10⁹/L; platelets count ≥100 x 10⁹/L;
hemoglobin ≥9.0 g/dL),
6. Normal hepatic function: total bilirubin ≤1.5 x upper limit of normal (ULN) (unless
documented Gilbert's syndrome); aspartate aminotransferase (ASAT) and alanine
aminotransferase (ALAT) ≤3 x ULN, and gamma-glutamyltransferase (GGT) ≤3 x ULN,
7. Normal renal function: serum creatinine ≤1.5 x ULN,
8. Normal cardiac function: ECG,
9. Patients affiliated to the French national health insurance,
10. Patient must have signed a written informed consent form prior to any study specific
procedures,
11. French language comprehension,
12. Patient is willing and able to comply with the protocol for the duration of the
study including undergoing treatment and scheduled visits and examinations including
follow up.
1. Patients aged ≥ 18 years old,
2. Eligible patient starting adjuvant oxaliplatin-based chemotherapy (6-12 cycles,
Simplified FOLFOX4) for stage II/III colorectal cancer,
3. Histological or cytological confirmation of colorectal cancer,
4. Performance status (ECOG) ≤2,
5. Normal hematological function (ANC ≥1.5 x 10⁹/L; platelets count ≥100 x 10⁹/L;
hemoglobin ≥9.0 g/dL),
6. Normal hepatic function: total bilirubin ≤1.5 x upper limit of normal (ULN) (unless
documented Gilbert's syndrome); aspartate aminotransferase (ASAT) and alanine
aminotransferase (ALAT) ≤3 x ULN, and gamma-glutamyltransferase (GGT) ≤3 x ULN,
7. Normal renal function: serum creatinine ≤1.5 x ULN,
8. Normal cardiac function: ECG,
9. Patients affiliated to the French national health insurance,
10. Patient must have signed a written informed consent form prior to any study specific
procedures,
11. French language comprehension,
12. Patient is willing and able to comply with the protocol for the duration of the
study including undergoing treatment and scheduled visits and examinations including
follow up.
1. Metastatic cancer,
2. Diagnosis of neuropathy,
3. EORTC QLQ-CIPN20 sensory score >6,
4. Previous neurotoxic chemotherapy treatment,
5. Patients with chronic obstructive pulmonary disease,
6. ALAT/ASAT elevated more than 3 times the normal value,
7. Patients with known allergy or severe hypersensitivity to riluzole or any of the
study drug excipients,
8. Dependence on alcohol or drugs,
9. Psychotic disorders,
10. Women pregnant or breastfeeding,
11. Patients undergoing a measure of legal protection (trusteeship, guardianship ...).