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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-002320-25 | EudraCT Number |
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Lack of treatment, sponsor decision.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Placebo | Placebo Comparator | Posology, administration and duration of treatment will be equivalent to riluzole group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Riluzole | Drug | Riluzole during chemotherapy (oxaliplatin) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months afer initiation of oxaliplatin based chemotherapy (1 cycle = 14 days) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICO - Site Paul Papin | Angers | France | ||||
| CH Beauvais |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31182448 | Derived | 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. |
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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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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).
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Placebo arm: The patient will be taken on tablet (placebo :50 mg, film-coated tablet) Posology, administration and duration of treatment will be equivalent to riluzole group.
| Placebo Oral Tablet |
| Drug |
placebo |
|
| 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. | throughout study completion, assessed up to 43 months |
| Brief Pain Inventory (BPI) questionnaire | This self-report questionnaire includes:
| 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. | 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. | 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. | 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. | 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). | 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. | 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. | 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. | 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 | 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. |
| Beauvais |
| France |
| Centre François Baclesse | Caen | France |
| Hia Percy | Clamart | France |
| CHU de Clermont -Ferrand | Clermont-Ferrand | France |
| Clinique St Côme | Compiègne | France |
| GHPSO | Creil | France |
| Centre Georges François Leclerc | Dijon | France |
| CHU de Dijon | Dijon | France |
| CH Annecy-Genevois | Pringy | France |
| CHU de Reims | Reims | France |
| Institut Jean Godinot | Reims | France |
| ICO - Site René Gauducheau | Saint-Herblain | France |
| Hia Begin | Saint-Mandé | France |
| CHU de Saint-Etienne | Saint-Priest | France |
| Hôpital Foch | Suresnes | France |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D019782 | Riluzole |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D052160 | Benzothiazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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