Oxaliplatin-induced Peripheral NeuropathyPhase 2RILUZOX-01NCT03722680
Effectiveness Assessment of Riluzole in the Prevention of Oxaliplatin-induced Peripheral Neuropathy.
A Phase 2 study testing Riluzole in people with Oxaliplatin-induced Peripheral Neuropathy, run by UNICANCER at 16 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oxaliplatin-induced Peripheral Neuropathy
- What is being tested?
- Riluzole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 16 sitesFrance
- Study dates
- 28 Oct 2020to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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,
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- 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 ...).
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
France16 sites
ICO - Site Paul Papin
Angers
CH Beauvais
Beauvais
Centre François Baclesse
Caen
Hia Percy
Clamart
CHU de Clermont -Ferrand
Clermont-Ferrand
Clinique St Côme
Compiègne
GHPSO
Creil
Centre Georges François Leclerc
Dijon
CHU de Dijon
Dijon
CH Annecy-Genevois
Pringy
CHU de Reims
Reims
Institut Jean Godinot
Reims
ICO - Site René Gauducheau
Saint-Herblain
Hia Begin
Saint-Mandé
CHU de Saint-Etienne
Saint-Priest
Hôpital Foch
Suresnes
About this study
Official title: Effectiveness Assessment of Riluzole in the Prevention of Oxaliplatin-induced Peripheral Neuropathy: A Phase II Randomized Study by UNICANCER With the Cooperation of AFSOS
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.
- Being tested
- Riluzole, Placebo Oral Tablet
- Keywords
- Riluzole, oxaliplatin, colorectal cancer, neuropathy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RiluzoleDrug
Riluzole during chemotherapy (oxaliplatin)
Placebo Oral TabletDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| Riluzole | Experimental | 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). Receives: Drug: Riluzole |
| Placebo | Placebo comparator | Posology, administration and duration of treatment will be equivalent to riluzole group. Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life questionnaire-chemotherapy-induced peripheral neuropathy (QLQ-CIPN20)
QLQ-CIPN20 Questionnaire (EORTC):
Self-reported questionnaire consisting of 20 questions that assess the symptoms and functional limitations of chemotherapy-induced peripheral neuropathy. The questionnaire is divided in 3 subscales: sensory, motor, and autonomic and gives a comprehensive picture of the nature, frequency, and severity of chemotherapy-induced peripheral neuropathy (CIPN). Using a 4-point Likert scale (1 = "not at all," 2 = "a little," 3 = "quite a bit," and 4 = "very much"), patients indicate the degree to which they have experienced sensory, motor, and autonomic symptoms.
Measured: 3 months afer initiation of oxaliplatin based chemotherapy (1 cycle = 14 days)
Secondary outcomes (12)
QLQ-CIPN20
Self-reported questionnaire consisting of 20 questions that assess the symptoms and functional limitations of chemotherapy-induced peripheral neuropathy. The questionnaire is divided in 3 subscales: sensory, motor, and autonomic and gives a comprehensive picture of the nature, frequency, and severity of CIPN. Using a 4-point Likert scale (1 = "not at all," 2 = "a little," 3 = "quite a bit," and 4 = "very much"), patients indicate the degree to which they have experienced sensory, motor, and autonomic symptoms.
Measured: At inclusion (V0), 3 months (V2), up to 7 months (V3), up to 9 months (V4), up to 12 months (V5), up to 15 months (V6), and up to 18 months (V7) after initiation of oxaliplatin based chemotherapy.
National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
The NCI-CTCAE v5.0 is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale will assess the severity of sensory neuropathic disorders, this derivative into 5 grades determined by the investigator.
Measured: throughout study completion, assessed up to 43 months
Brief Pain Inventory (BPI) questionnaire
This self-report questionnaire includes:
- A body schema
- The maximum pain, lowest pain, usual pain within the last 15 days (Numerical Numeric rating scales (NRS) 0 to 10
- Description of current analgesic treatment,
- An assessment of relief by a percentage scale (0-100%), Assessment of the impact of pain on: mood, relationships with others, walking, sleep, work, happiness the joy - of living, recreation, activities in general (digital scales, rating from 0 [normal] to 10 [no activity]).
Measured: At inclusion (V0), 3 months (V2), up to 7 months (V3), up to 9 months (V4), up to 12 months (V5), up to 15 months (V6), and up to 18 months (V7) after initiation of oxaliplatin based chemotherapy.
Douleur Neuropathique 4 (DN4) questionnaire (interview portion)
The interview portion of the DN4 questionnaire is a clinician-administered screening tool for neuropathic pain. The questionnaire includes 7 items, grouped into two questions. Each item, is answered as either YES or NO. A final cumulative patient's score is obtained by allocating 1 point for each YES and 0 point for each NO. If the patient's score is ≥3/7, the test is positive.
Measured: This evaluation will be carried out only if the item 5 of BPI "general pain felt in the last 7 days" is ≥4/10.
Neuropathic Pain Symptom Inventory (NPSI) questionnaire
This self-reported questionnaire assesses different neuropathic pain symptoms. The French NPSI includes 12 items that discriminates and quantifies five distinct dimensions of neuropathic pain. Each of these items are quantified on a (0-10) numerical scale.
Measured: This evaluation will be carried out only if the item 5 of BPI "general pain felt in the last 7 days" is ≥4/10.
QLQ-C30 questionnaire (EORTC)
This self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials.
The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease.
All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
Measured: At inclusion (V0), 3 months (V2), up to 7 months (V3), up to 9 months (V4), up to 12 months (V5), up to 15 months (V6), and up to 18 months (V7) after initiation of oxaliplatin based chemotherapy.
Disease progression
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.
Measured: From date of randomisation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 43 months.
Time to HRQoL score deterioration
The interval between randomization and deterioration ≥5 points in the HRQoL score as compared to baseline score or death (all causes).
Measured: At inclusion (V0), 3 months (V2), up to 7 months (V3), up to 9 months (V4), up to 12 months (V5), up to 15 months (V6), and up to 18 months (V7) after initiation of oxaliplatin based chemotherapy.
Quantification of chemotherapy dose reductions
The number of chemotherapy dose reduction caused by severe neuropathy and/or poor tolerance of treatment will be recorded.
Measured: 3 months (V2) and up to 7 months (V3) after initiation of oxaliplatin based chemotherapy.
Quantification of cumulative dose
The cumulative dose (mg/m²) of chemotherapy delivered to patients will be recorded.
Measured: 3 months (V2) and up to 7 months (V3) after initiation of oxaliplatin based chemotherapy.
Evaluation of study exit rates
The study exit rate caused by severe neuropathy and/or poor tolerance of treatment will be recorded.
Measured: 3 months (V2) and up to 7 months (V3) after initiation of oxaliplatin based chemotherapy.
Assessment of glutamate serum level
Correlation with colorectal cancer tumors/nodes/metastases (TNM) score (and eventually neuropathic symptoms), glutamate plasmatic
Measured: Glutamate serum level will be dose at inclusion (V0), 3 months (V2), up to 7 months (V3), and up to 18 months (V7) after initiation of oxaliplatin based chemotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2018
- Study start28 Oct 2020
- Primary completion1 Aug 2024
- Study completion31 Dec 2026 (estimated)
Why it stopped: Lack of treatment, sponsor decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oxaliplatin-induced Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by UNICANCERThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Riluzole arm: The patient will be taken one tablet (riluzole 50 mg, film-coated 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).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03722680
- Sponsor's protocol ID
- UC-0106/1712
- Other IDs
- 2017-002320-25, 2017
- Acronym
- RILUZOX-01
- Status last verified
- Apr 2026
- First submitted
- 11 Oct 2018
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.
Publications
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.
PubMed 31182448
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Assessment of Riluzole in the Prevention of Oxaliplatin-induced Peripheral Neuropathy: A Phase II Randomized Study by UNICANCER With the Cooperation of AFSOS
- ClinicalTrials.gov ID
- NCT03722680
- Acronym / sponsor ID
- RILUZOX-01 / UC-0106/1712
- Keywords
- Riluzole, oxaliplatin, colorectal cancer, neuropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Lack of treatment, sponsor decision.
- Enrolment
- 80 participants (actual)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Study start
- 28 Oct 2020 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Riluzole arm: The patient will be taken one tablet (riluzole 50 mg, film-coated 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).
| Arm | Type | Receives |
|---|---|---|
| Riluzole | Experimental | Drug: RiluzoleThe 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). |
| Placebo | Placebo comparator | Drug: Placebo Oral TabletPosology, administration and duration of treatment will be equivalent to riluzole group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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),
Key exclusion criteria (11 listed)
- Metastatic cancer,
- Diagnosis of neuropathy,
- EORTC QLQ-CIPN20 sensory score >6,
- Previous neurotoxic chemotherapy treatment,
- Patients with chronic obstructive pulmonary disease,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RiluzoleRiluzole during chemotherapy (oxaliplatin) | Drug | Riluzole |
| Placebo Oral Tabletplacebo | Drug | Placebo |
Primary outcome
Quality of life questionnaire-chemotherapy-induced peripheral neuropathy (QLQ-CIPN20)
Time frame: 3 months afer initiation of oxaliplatin based chemotherapy (1 cycle = 14 days)
QLQ-CIPN20 Questionnaire (EORTC): Self-reported questionnaire consisting of 20 questions that assess the symptoms and functional limitations of chemotherapy-induced peripheral neuropathy. The questionnaire is divided in 3 subscales: sensory, motor, and autonomic and gives a comprehensive picture of the nature, frequency, and severity of chemotherapy-induced peripheral neuropathy (CIPN). Using a 4-point Likert scale (1 = "not at all," 2 = "a little," 3 = "quite a bit," and 4 = "very much"), patients indicate the degree to which they have experienced sensory, motor, and autonomic symptoms.
12 secondary outcomes
QLQ-CIPN20
Time frame: At inclusion (V0), 3 months (V2), up to 7 months (V3), up to 9 months (V4), up to 12 months (V5), up to 15 months (V6), and up to 18 months (V7) after initiation of oxaliplatin based chemotherapy.
National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
Time frame: throughout study completion, assessed up to 43 months
Brief Pain Inventory (BPI) questionnaire
Time frame: At inclusion (V0), 3 months (V2), up to 7 months (V3), up to 9 months (V4), up to 12 months (V5), up to 15 months (V6), and up to 18 months (V7) after initiation of oxaliplatin based chemotherapy.
Douleur Neuropathique 4 (DN4) questionnaire (interview portion)
Time frame: This evaluation will be carried out only if the item 5 of BPI "general pain felt in the last 7 days" is ≥4/10.
Neuropathic Pain Symptom Inventory (NPSI) questionnaire
Time frame: This evaluation will be carried out only if the item 5 of BPI "general pain felt in the last 7 days" is ≥4/10.
QLQ-C30 questionnaire (EORTC)
Time frame: At inclusion (V0), 3 months (V2), up to 7 months (V3), up to 9 months (V4), up to 12 months (V5), up to 15 months (V6), and up to 18 months (V7) after initiation of oxaliplatin based chemotherapy.
Disease progression
Time frame: From date of randomisation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 43 months.
Time to HRQoL score deterioration
Time frame: At inclusion (V0), 3 months (V2), up to 7 months (V3), up to 9 months (V4), up to 12 months (V5), up to 15 months (V6), and up to 18 months (V7) after initiation of oxaliplatin based chemotherapy.
Quantification of chemotherapy dose reductions
Time frame: 3 months (V2) and up to 7 months (V3) after initiation of oxaliplatin based chemotherapy.
Quantification of cumulative dose
Time frame: 3 months (V2) and up to 7 months (V3) after initiation of oxaliplatin based chemotherapy.
Evaluation of study exit rates
Time frame: 3 months (V2) and up to 7 months (V3) after initiation of oxaliplatin based chemotherapy.
Assessment of glutamate serum level
Time frame: Glutamate serum level will be dose at inclusion (V0), 3 months (V2), up to 7 months (V3), and up to 18 months (V7) after initiation of oxaliplatin based chemotherapy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Derived from this study: PubMed 31182448Kerckhove 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.
- Individual participant dataSharing planned: No. Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Riluzole in people with Oxaliplatin-induced Peripheral Neuropathy, run by UNICANCER at 16 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life questionnaire-chemotherapy-induced peripheral neuropathy (QLQ-CIPN20) (time frame: 3 months afer initiation of oxaliplatin based chemotherapy (1 cycle = 14 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03722680, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.