Effectiveness Assessment of Riluzole in the Prevention of Oxaliplatin-induced Peripheral Neuropathy: A Phase II Randomized Study by UNICANCER With the Cooperation of AFSOS
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 发起方
- UNICANCER
- 入组人数
- 80
- 试验地点
- 16
- 主要终点
- Quality of life questionnaire-chemotherapy-induced peripheral neuropathy (QLQ-CIPN20)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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 ...).
研究组 & 干预措施
Riluzole
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).
干预措施: Riluzole (Drug)
Placebo
Posology, administration and duration of treatment will be equivalent to riluzole group.
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Quality of life questionnaire-chemotherapy-induced peripheral neuropathy (QLQ-CIPN20)
时间窗: 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.
次要结局
- National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0(throughout study completion, assessed up to 43 months)
- Douleur Neuropathique 4 (DN4) questionnaire (interview portion)(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)(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.)
- QLQ-CIPN20(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(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.)
- Quantification of chemotherapy dose reductions(3 months (V2) and up to 7 months (V3) after initiation of oxaliplatin based chemotherapy.)
- Quantification of cumulative dose(3 months (V2) and up to 7 months (V3) after initiation of oxaliplatin based chemotherapy.)
- Evaluation of study exit rates(3 months (V2) and up to 7 months (V3) after initiation of oxaliplatin based chemotherapy.)
- Brief Pain Inventory (BPI) questionnaire(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.)
- Neuropathic Pain Symptom Inventory (NPSI) questionnaire(This evaluation will be carried out only if the item 5 of BPI "general pain felt in the last 7 days" is ≥4/10.)
- Time to HRQoL score deterioration(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.)
- Assessment of glutamate serum level(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.)