Effectiveness Assessment of Riluzole in the Prevention of Oxaliplatin-induced Peripheral Neuropathy. (RILUZOX-01)

Unicancer

Status and phase: Suspended; Phase 2

Conditions: Oxaliplatin-induced Peripheral Neuropathy

Treatments: Drug: Placebo Oral Tablet; Drug: Riluzole

Study type: Interventional

Funder types: Other

Identifiers

NCT03722680

2017-002320-25 (EudraCT Number)

UC-0106/1712

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 ...).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

Riluzole

Experimental group

Description:

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).

Treatment:

Drug: Riluzole

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo Oral Tablet