Intravesical Gemcitabine Docetaxel vs Bacillus Calmette Guerin A comparative study of adjuvant treatment in Intermediate and High Risk Non Muscle Invasive Bladder Cancer
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 1
研究概览
简要总结
This Randomized controlled open labelled trial aims to compare adjuvant intravesical treatment of non muscle invasive urinary bladder cancer falling under intermediate and high risk group according to latest AUA guidelines using sequential Gemcitabine docetaxel administration vs Standard BCG therapy in terms of recurrence free survival and side effect profile, tolerance to treatment and treatment discontinuation rates.
In the era of global BCG Shortage and looking into the side effect profile and treatment discontinuation rates of patients recieveing BCG , this trial , if proven that GEMDOCE treatment is comparable or better than BCG , can aid in management of such patients as a standarized treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with histopathology reported non muscle invasive bladder cancer falling under category of intermediate and high risk NMIBC as per AUA Guidelines will be included in the study group.
- •Patients will be included only after valid informed written consent for the study Adult patients above 18 yr and less than or equal to 80 years will be included.
- •Both male and female patients will be included.
排除标准
- •Patients not giving consent to be the part of study.
- •Patients with muscle invasive bladder cancer.
- •Pregnant and lactating females.
研究者
Vineet Bhardwaj
Superspeciality Hospital Government Medical College Jammu.