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Effectiveness assessment of riluzole in the prevention of oxaliplatin-induced peripheral neuropathy: A phase II randomized study by the UNICANCER with cooperation of AFSOS. - RILUZOX-01

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002320-25-FR

Enrollment

210

Registered

2018-06-07

Start date

2018-07-03

Completion date

Unknown

Last updated

2024-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal cancer stage II/III with adjuvant oxaliplatin-based chemotherapy (simplified FOLFOX4)

Interventions

Trade Name: RILUTEK Pharmaceutical Form: Coated tablet INN or Proposed INN: RILUZOLE CAS Number: 1744-22-5 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharm

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients aged = 18 years old, 2. Eligible patient starting adjuvant oxaliplatin-based chemotherapy (simplified FOLFOX4) for stage II/III colorectal cancer, 3. Histological or cytological confirmation of a colorectal cancer, 4. PS (ECOG) = 2, 5. Normal hepatic function: total bilirubin =1.5 x upper limit of normal (ULN) (unless documented Gilbert’s syndrome); ASAT and ALAT =3 x ULN, and GGT=3 x ULN. 6. Normal renal function: creatinine clearance (CL) >40 mL/min or calculated creatinine clearance CL>40 mL/min (Cockcroft-Gault formula), 7. Normal cardiac function: ECG 8. Patients affiliated to the French national or European health insurance, 9. Patient must have signed a written informed consent form prior to any study specific procedures, 10. French language comprehension, 11. 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 180 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

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. ALT / AST 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 and / or drugs, 9. Psychotic disorders 10. Women pregnant or breastfeeding, 11. Patients undergoing a measure of legal protection (trusteeship, guardianship ...).

Design outcomes

Primary

Measure	Time frame
Main Objective: Assess the preventive efficacy of riluzole on the severity of oxaliplatin-induced peripheral neuropathy in stage II/III CRC patients;Secondary Objective: - To assess the effect of riluzole on •Neuropathic pain, •Incidence of neuropathy, •Impact on Health-related quality of life (HRQoL), •Disease Free Survival, •Overall Survival •Time to Treatment Failure. •Time to HRQoL score deterioration •Toxicity (NCI-CTC V5.0) - To quantify and compare the chemotherapy dose reductions, cumulative doses, and study exit rates in the study arms. - To correlate glutamate serum levels with colorectal cancer TNM scores and symptoms of OIPN ;Primary end point(s): For the primary endpoint of the study, only the sensory scale scores will be assessed. ;Timepoint(s) of evaluation of this end point: After 6 cycles of chemotherapy (V2 visit)	—

Measure

Time frame

Main Objective: Assess the preventive efficacy of riluzole on the severity of oxaliplatin-induced peripheral neuropathy in stage II/III CRC patients;Secondary Objective: - To assess the effect of riluzole on •Neuropathic pain, •Incidence of neuropathy, •Impact on Health-related quality of life (HRQoL), •Disease Free Survival, •Overall Survival •Time to Treatment Failure. •Time to HRQoL score deterioration •Toxicity (NCI-CTC V5.0) - To quantify and compare the chemotherapy dose reductions, cumulative doses, and study exit rates in the study arms. - To correlate glutamate serum levels with colorectal cancer TNM scores and symptoms of OIPN ;Primary end point(s): For the primary endpoint of the study, only the sensory scale scores will be assessed. ;Timepoint(s) of evaluation of this end point: After 6 cycles of chemotherapy (V2 visit)

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Secondary

Measure	Time frame
Secondary end point(s): - Sensory, motor and autonomic scales from QLQ-CIPN20 questionnaire & longitudinal analysis, - Grade of chemotherapy-induced peripheral neuropathy (NCI-CTCAE v5.0), - Score of pain by the BPI SF questionnaire, screening of neuropathic pain by the DN4 interview questionnaire and characterization of neuropathic pain by NPSI questionnaire, - Health-related quality of life (HRQoL) by the QLQ-C30 questionnaire (EORTC) & longitudinal analysis, - Disease Free Survival, defined as the interval between the date of randomization and the date of cancer relapse (local, regional, metastases, second cancer) or death from any cause, whichever occurs first, - Overall survival, defined as the interval between the date of randomization and the date of death from any cause, - Time to treatment failure, defined as the interval between randomization to treatment discontinuation for any reason, including disease progression, treatment toxicity, patient preference, or death, - Time to HRQoL score deterioration, defined as the interval between randomization and deterioration = 5 points in the HRQoL score as compared to baseline score or death (all causes), - Quantification of chemotherapy dose reductions following a chemotherapy-induced neuropathy, - Assessment of adverse events (excluding chemotherapy-induced neuropathies) associated with cancer, anticancer chemotherapy and study treatment (NCI-CTCAE v5.0), - Cumulative dose of anticancer received by the patients, - Assessment of glutamate serum level for correlation with CRC TNM score and neuropathy. ;Timepoint(s) of evaluation of this end point: _	—

Measure

Time frame

Secondary end point(s): - Sensory, motor and autonomic scales from QLQ-CIPN20 questionnaire & longitudinal analysis, - Grade of chemotherapy-induced peripheral neuropathy (NCI-CTCAE v5.0), - Score of pain by the BPI SF questionnaire, screening of neuropathic pain by the DN4 interview questionnaire and characterization of neuropathic pain by NPSI questionnaire, - Health-related quality of life (HRQoL) by the QLQ-C30 questionnaire (EORTC) & longitudinal analysis, - Disease Free Survival, defined as the interval between the date of randomization and the date of cancer relapse (local, regional, metastases, second cancer) or death from any cause, whichever occurs first, - Overall survival, defined as the interval between the date of randomization and the date of death from any cause, - Time to treatment failure, defined as the interval between randomization to treatment discontinuation for any reason, including disease progression, treatment toxicity, patient preference, or death, - Time to HRQoL score deterioration, defined as the interval between randomization and deterioration = 5 points in the HRQoL score as compared to baseline score or death (all causes), - Quantification of chemotherapy dose reductions following a chemotherapy-induced neuropathy, - Assessment of adverse events (excluding chemotherapy-induced neuropathies) associated with cancer, anticancer chemotherapy and study treatment (NCI-CTCAE v5.0), - Cumulative dose of anticancer received by the patients, - Assessment of glutamate serum level for correlation with CRC TNM score and neuropathy. ;Timepoint(s) of evaluation of this end point: _

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Countries

France

Contacts

Public ContactProject Manager

UNICANCER

v-plence@unicancer.fr33171 93 67 07

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026

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