Sequential Intravesical Gemcitabine and Docetaxel for Rescue Therapy in BCG Unresponsive Non-muscle Invasive Bladder Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Recurrence rate
研究概览
简要总结
Studies in the literature are limited both throughout Turkey and in general. For this reason, as a result of the study that we will create, it will provide us with information for bladder protective treatments in patients who do not respond to BCG therapy in bladder cancer patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BCG refractory/relapsed/unresponsive or intolerant Who do not want or are not suitable for radical cystectomy
排除标准
- •BCG naive A history of multiple cancers Having a radical cystectomy plan
研究组 & 干预措施
Patients with BCG unresponsiveness and receiving intravesical gemcitabine doxetaxel
干预措施: Intravesical Solution (Drug)
结局指标
主要结局
Recurrence rate
时间窗: 5 years
the recurrence rate after intravesical chemotherapy will be calculated
Progression rate
时间窗: 5 years
the progression rate after intravesical chemotherapy will be calculated
Adverse effects of intravesical chemotherapy
时间窗: 5 years
the patients' data will be retrospectively analyzed to investigate the side effects of intravesical chemotherapy
Intravesical chemotherapy versus radical cystectomy
时间窗: 5 years
the long-term cancer specific survival, overal survival, recurrence free survival of patients with similar pathological characteristics and who underwent radical cystectomy and patients who were given intravesical chemotherapy will be compared
次要结局
- treatment change(5 years)
研究者
Muhammed Selcuk Ozer
Doctor
Dokuz Eylul University