Effectiveness Assessment of Riluzole in the Prevention of Oxaliplatin-induced Peripheral Neuropathy. (NCT03722680) | Clinical Trial Compass
SuspendedPhase 2
Effectiveness Assessment of Riluzole in the Prevention of Oxaliplatin-induced Peripheral Neuropathy.
Stopped: Lack of treatment, sponsor decision.
France80 participantsStarted 2020-10-28
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
. 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,
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is currently suspended — do you know why it was suspended, and does that affect whether riluzole is still considered a promising option for preventing oxaliplatin-induced nerve damage?
2Since this is a Phase 2 trial, the safety and effectiveness of riluzole for this purpose aren't fully established yet — how does that uncertainty compare to any standard approaches you'd recommend to protect my nerves during oxaliplatin treatment?
3The trial measures success using a quality-of-life questionnaire focused on chemotherapy-induced peripheral neuropathy (QLQ-CIPN20) — what kinds of nerve symptoms does that tool track, and how significant is peripheral neuropathy typically for patients on the oxaliplatin regimen I'd be receiving?
4Riluzole is a drug primarily known for treating ALS — are there any side effects or interactions I should be aware of if it were used alongside my chemotherapy, especially given that this trial is still in an early testing phase?
5Given that this trial is suspended and may not be actively enrolling, are there other studies or evidence-based strategies you'd recommend to help prevent or manage nerve damage from oxaliplatin in my specific situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Quality of life questionnaire-chemotherapy-induced peripheral neuropathy (QLQ-CIPN20)
Timeframe: 3 months afer initiation of oxaliplatin based chemotherapy (1 cycle = 14 days)