A Multicenter, Randomized Double-blind Placebo Controlled Phase III Study of the Efficacy of Xaliproden in Preventing the Neurotoxicity of Oxaliplatin in First-line Treatment of Patients With Metastatic Colorectal Cancer Treated With Oxaliplatin / 5-FU/LV
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 879
- 试验地点
- 1
- 主要终点
- Clinical evaluation of peripheral sensory neuropathy using the Oxaliplatin specific scale for dose adjustment
研究概览
简要总结
Primary Objective : Compare the risk of occurrence of Grade3-4 cumulative peripheral sensory neuropathy (PSN) relative to cumulative dose of oxaliplatin between treatment group and placebo group.
Main Secondary Objective : Compare the response rate (RR) between treatment group and placebo group in order to ensure that the efficacy of the chemotherapy is not compromised by the addition of xaliproden to the chemotherapeutic regimen.
Other Secondary Objectives : study of the neurotoxicity parameters (Duration of oxaliplatin-induced PSN (G2,3,4); overall incidence of PSN during treatment; dose of onset of PSN ; incidence of dose-reduction and dose delay due to PSN; incidence of oxaliplatin treatment discontinuation due to PSN; change in Nerve Conduction Studies (NCS)) ; study of the safety profile (other than PSN) ; study of the chemotherapy efficacy (progression free survival, overall survival).
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
- Triple (Participant, Care Provider, Investigator)
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
- •Main inclusion criteria :
- •Histologically or cytologically-proven metastatic cancer of the colon or rectum.
- •Metastatic disease not amenable to potentially curative treatment (eg: inoperable metastatic disease).
- •Male or female aged >18 years.
- •WHO Performance Status (PS) : 0 or
- •Measurable disease.
- •No prior chemotherapeutic regimen for metastatic disease.
- •Disease-free interval from end of adjuvant therapy of at least 6 months (1 year if oxaliplatin was part of the adjuvant therapy).
- •Prior radiotherapy is permitted if it was not administered to target lesions identified for this study - unless progression within the radiation portal is documented - and provided it has been completed at least 3 weeks before randomization.
- •Signed written informed consent prior to study entry.
排除标准
- •Main exclusion criteria :
- •Any condition or past medical history that contra-indicates treatment with oxaliplatin and 5-FU, as reported in approved labeling information.
- •Received chemotherapeutic agents other than 5-FU, LV, Levamisole, irinotecan, capecitabine, oxaliplatin as part of adjuvant therapy.
- •Peripheral neuropathy >Grade
- •Concomitant treatments with drugs/ingredients reported to have a potential activity in preventing peripheral sensory neuropathy.
- •Concurrent active cancer originating from a primary site other than colon or rectum.
- •Presence of any symptom suggesting brain metastasis.
研究组 & 干预措施
Xaliproden (SR57746A)
干预措施: Xaliproden (SR57746A) (Drug)
Xaliproden (SR57746A)
干预措施: Oxaliplatin (Drug)
Xaliproden (SR57746A)
干预措施: 5-Fluorouracil (Drug)
Xaliproden (SR57746A)
干预措施: Leucovorin (Drug)
Placebo
干预措施: Placebo (Drug)
Placebo
干预措施: Oxaliplatin (Drug)
Placebo
干预措施: 5-Fluorouracil (Drug)
Placebo
干预措施: Leucovorin (Drug)
结局指标
主要结局
Clinical evaluation of peripheral sensory neuropathy using the Oxaliplatin specific scale for dose adjustment
时间窗: Q2W during treatment, Q4W to Q12W during post-treatment follow-up
次要结局
- Main: response rate using RECIST criteria(Q8W)
- Other: nerve conduction studies(baseline, end of treatment with oxaliplatin, end of treatment with study drug)
- Other: progression free survival and survival(Q8W and study period)