Randomized Study of LAROTAXEL + Cisplatin (LC) vs. Gemcitabine + Cisplatin (GC) in the First Line Treatment of Locally Advanced/Metastatic Urothelial Tract or Bladder Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 337
- 试验地点
- 160
- 主要终点
- Overall survival defined as the time interval from the date of randomization to the date of death due to any cause
研究概览
简要总结
This is a randomized, open-label, multi-center study comparing the efficacy and safety of XRP9881 plus cisplatin to gemcitabine plus cisplatin in the first line treatment of locally advanced/metastatic urothelial tract or bladder cancer. The primary objective is to compare overall survival. Secondary objectives include comparisons of progression free survival, objective response rate, time to definitive deterioration of performance status, duration of response, time to definitive weight loss, and assessments of overall safety, and pharmacokinetics. Patients are treated until disease progression, death, or unacceptable toxicity and are followed-up until death or the end of the study whichever comes first.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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 with histology/cytology confirmed Transitional Cell Carcinoma (TCC) with locally advanced (T4b) or metastatic urothelial tract or bladder cancer
- •ECOG Performance Status 0 or 1
- •No prior palliative chemotherapy
排除标准
- •(Neo)Adjuvant chemotherapy if < 6 months between end of (neo)adjuvant chemotherapy and relapse
- •Less than 6 weeks elapsed from prior radiotherapy and less than 3 weeks from surgery to time of randomization
- •Prior cisplatin as (neo)adjuvant chemotherapy with cumulative dose > 300 mg/m²
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
1
干预措施: larotaxel (XRP9881) (Drug)
1
干预措施: cisplatin (Drug)
2
干预措施: gemcitabine (Drug)
2
干预措施: cisplatin (Drug)
结局指标
主要结局
Overall survival defined as the time interval from the date of randomization to the date of death due to any cause
时间窗: study period
次要结局
- Radiological tumor assessments (CT/MRI)(at screening, every 8 weeks during treatment, at end of treatment, and in follow-up until documented disease progression)
- Adverse Events, laboratory assessments, vital signs, Physical Examinations, and ECOG Performance Status(at screening and every cycle)