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

NCT ID: NCT03722680

Last Updated: 2025-04-23

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-28
• Study Completion Date: 2025-12-31

Brief 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.

Conditions

Oxaliplatin-induced Peripheral Neuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Riluzole

The patient will be taken one tablet twice a day, in the morning and in the evening during the meal (12h interval). The medication is taken during the 14 days of each chemotherapy cycle, beginning 7 days before the start of chemotherapy and ending 2 weeks after the start of last cycle of chemotherapy (25 weeks). The treatment ends with the cessation of chemotherapy (visit V3 or anticipated stop).

Group Type: EXPERIMENTAL

Riluzole

Intervention Type: DRUG

Riluzole during chemotherapy (oxaliplatin)

Placebo

Posology, administration and duration of treatment will be equivalent to riluzole group.

Group Type: PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type: DRUG

placebo

Interventions

Riluzole

Riluzole during chemotherapy (oxaliplatin)

Intervention Type: DRUG

Placebo Oral Tablet

placebo

Intervention Type: DRUG

Eligibility Criteria

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.

Exclusion Criteria

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 ...).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UNICANCER

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

France

References

Kerckhove N, Busserolles J, Stanbury T, Pereira B, Plence V, Bonnetain F, Krakowski I, Eschalier A, Pezet D, Balayssac D. Effectiveness assessment of riluzole in the prevention of oxaliplatin-induced peripheral neuropathy: RILUZOX-01: protocol of a randomised, parallel, controlled, double-blind and multicentre study by the UNICANCER-AFSOS Supportive Care intergroup. BMJ Open. 2019 Jun 9;9(6):e027770. doi: 10.1136/bmjopen-2018-027770.

Reference Type: DERIVED

PMID: 31182448 (View on PubMed)

Other Identifiers

2017-002320-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

UC-0106/1712

Identifier Type: -

Identifier Source: org_study_id