Randomized Study of LAROTAXEL + Cisplatin (LC) vs. Gemcitabine + Cisplatin (GC) in the First Line Treatment of Locally Advanced/Metastatic Urothelial Tract or Bladder Cancer

Sanofi Synthelabo India Limited6 个研究点分布在 1 个国家目标入组 900 人开始时间: 2008年9月1日最近更新: 2018年10月30日

试验速览

阶段: 3 期
状态: Other
发起方: Sanofi Synthelabo India Limited
入组人数: 900
试验地点: 6
主要终点: To compare overall survival (OS) of patients administered larotaxel in combination with cisplatin vs. gemcitabine in combination with cisplatin for the treatment of locally advanced /metastatic urothelial tract or bladder cancer

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Trial will be conducted in 21 countries all over the world. From India 13 patients were enrolled in the study.

研究设计

研究类型: Interventional
分配方式: Computer generated randomization
盲法: Open Label

入排标准

年龄范围: 18.00 Year(s) 至 99.00 Year(s)（—）
性别: All

入选标准

•1.Patients with histology/cytology confirmed Transitional Cell Carcinoma (TCC) with locally advanced (T4b) or metastatic urothelial tract or bladder cancer 2.ECOG Performance Status ≤ 2 3.No prior palliative chemotherapy.

排除标准

•(Neo)Adjuvant chemotherapy if < 6 months between end of (neo)adjuvant chemotherapy and relapse 2.Less than 6 weeks elapsed from prior radiotherapy and less than 3 weeks from surgery to time of randomization 3.Prior cisplatin as (neo)adjuvant chemotherapy with cumulative dose > 300 mg/m².

结局指标

主要结局

To compare overall survival (OS) of patients administered larotaxel in combination with cisplatin vs. gemcitabine in combination with cisplatin for the treatment of locally advanced /metastatic urothelial tract or bladder cancer

时间窗: The primary efficacy endpoint is the Overall Survival (OS) that is defined as the time from the date of randomization to death with all cause.

次要结局

To compare Progression Free Survival (PFS), Objective(Response Rate (ORR), time to definitive deterioration of PS, Duration of Response (DR), and time to definitive 5% weight loss of larotaxel in combination with cisplatin vs. gemcitabine combined with cisplatin.)

研究者

发起方

Sanofi Synthelabo India Limited

申办方类型

Pharmaceutical industry-Global

研究点 (6)

Loading locations...

相似试验

未知

2 期

Phase II Study for Previously Untreated Subjects With Non Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC)

CTRI/2007/091/000039The pharmaceutical company sponsoring this study is Bristol-MyersSquibb

已完成

不适用

Multicenter randomized clinical trial in Patients with Juvenile Idiopathic Arthritis and Methotrexate related side effects: Psychological Behavioural therapy versus switch to MTX parenteral versus standard of careJuvenile Idiopathic Arthritis

NL-OMON38373niversitair Medisch Centrum Utrecht450

已完成

4 期

A prospective randomised controlled multicentre trial comparing half-dose photodynamic therapy (PDT) with high-density subthreshold micropulse laser treatment in patients with chronic central serous chorioretinopathy (CSC).Chronic central serous chorioretinopathy10047060

NL-OMON39842niversitair Medisch Centrum119

已完成

4 期

Comparison of Biphasic Insulin Aspart 30 Versus Insulin Glargine Both in Combination With Metformin and Glimepiride in Subjects With Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2

NCT00469092Novo Nordisk A/S480

已完成

4 期

A randomized, multicentre, double-blind, parallel, sham-controlled study of the gammaCore®, a non-invasive neurostimulator device for the acute relief of episodic and chronic cluster headache.cluster headaches10019231

NL-OMON40599electroCore LLC35