EUCTR2017-002320-25-FR进行中（未招募）1 期
Effectiveness assessment of riluzole in the prevention of oxaliplatin-induced peripheral neuropathy: A phase II randomized study by the UNICANCER with cooperation of AFSOS. - RILUZOX-01
ICANCER0 个研究点目标入组 210 人开始时间: 2018年6月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 210
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patients aged = 18 years old,
- •2. Eligible patient starting adjuvant oxaliplatin-based chemotherapy (simplified FOLFOX4) for stage II/III colorectal cancer,
- •3. Histological or cytological confirmation of a colorectal cancer,
- •4. PS (ECOG) = 2,
- •5. Normal hepatic function: total bilirubin =1.5 x upper limit of normal (ULN) (unless documented Gilbert’s syndrome); ASAT and ALAT =3 x ULN, and GGT=3 x ULN.
- •6. Normal renal function: creatinine clearance (CL) >40 mL/min or calculated creatinine clearance CL>40 mL/min (Cockcroft-Gault formula),
- •7. Normal cardiac function: ECG
- •8. Patients affiliated to the French national or European health insurance,
- •9. Patient must have signed a written informed consent form prior to any study specific procedures,
- •10. French language comprehension,
- •11. 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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 180
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1. Metastatic cancer,
- •2. Diagnosis of neuropathy,
- •3. EORTC QLQ-CIPN20 sensory score > 6,
- •4. Previous neurotoxic chemotherapy treatment,
- •5. Patients with chronic obstructive pulmonary disease,
- •6. ALT / AST elevated more than 3 times the normal value,
- •7. Patients with known allergy or severe hypersensitivity to riluzole or any of the study drug excipients,
- •8. Dependence on alcohol and / or drugs,
- •9. Psychotic disorders
- •10. Women pregnant or breastfeeding,
- •11. Patients undergoing a measure of legal protection (trusteeship, guardianship ...).
研究者
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