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

  • STATUS
    Recruiting
  • End date
    Apr 28, 2024
  • participants needed
    210
  • sponsor
    UNICANCER
Updated on 17 June 2022

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.

Details
Condition Oxaliplatin-induced Peripheral Neuropathy
Treatment Placebo Oral Tablet, Riluzole
Clinical Study IdentifierNCT03722680
SponsorUNICANCER
Last Modified on17 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients aged ≥ 18 years old
Eligible patient starting adjuvant oxaliplatin-based chemotherapy (6-12 cycles, Simplified FOLFOX4) for stage II/III colorectal cancer
Histological or cytological confirmation of colorectal cancer
Performance status (ECOG) ≤2
Normal hematological function (ANC ≥1.5 x 10⁹/L; platelets count ≥100 x 10⁹/L; hemoglobin ≥9.0 g/dL)
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
Normal renal function: serum creatinine ≤1.5 x ULN
Normal cardiac function: ECG
Patients affiliated to the French national health insurance
Patient must have signed a written informed consent form prior to any study specific procedures
French language comprehension
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

Metastatic cancer
Diagnosis of neuropathy
EORTC QLQ-CIPN20 sensory score >6
Previous neurotoxic chemotherapy treatment
Patients with chronic obstructive pulmonary disease
ALAT/ASAT elevated more than 3 times the normal value
Patients with known allergy or severe hypersensitivity to riluzole or any of the study drug excipients
Dependence on alcohol or drugs
Psychotic disorders
Women pregnant or breastfeeding
Patients undergoing a measure of legal protection (trusteeship, guardianship ...)
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