Prospective Randomized Trial of Adjuvant Radiotherapy Versus Observation After Radical Cystectomy in High Risk Urothelial Bladder Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Local Control
研究概览
简要总结
This is a prospective randomized clinical trial in high risk urothelial bladder cancer to compare adjuvant radiotherapy versus observation after radical cyctectomy. This is to clarify the benefit of adjuvant radiotherapy while limiting gastrointestinal toxicities for patients with pathological high-risk bladder cancer through assessing locoregional control (LRC).
详细描述
This is prospective randomized trial in high risk urothelial bladder cancer that includes 2 arms. The randomization will be done by permuted block method to 2 equal comparable groups. The total number of subjects will be 50 in each arm (Total=100 subjects).
This study include patients who may receive neoadjuvant chemotherapy [Gemcitabine+Cisplatin]) or not.
Arm (1) in this study (N=50) will received irradiation of both the bladder tumor bed and pelvic lymph nodes using IMRT technique. For Arm (2) (N=50) will undergo observation following radical cystectomy.
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
- •Patient with muscle-invasive urothelial cancer, who received neoadjuvant chemotherapy followed by radical cystectomy and urinary diversion with negative safety margin and belongs to one or more of the categories:
- •≥ 18 years old.
- •PT3 or PT4a tumors.
- •Grade 3 urothelial cancer.
- •Positive infiltration of the dissected pelvic lymph nodes.
排除标准
- •Residual tumors upon cystectomy.
- •Previous pelvic irradiation.
- •Non-urothelial bladder tumors.
- •WHO performance status above
- •Any psychological, familial, sociological or geographical condition that hamper compliance with the study and/ or follow up schedule.
结局指标
主要结局
Local Control
时间窗: Two year
2-year local-regional control rate
次要结局
- Disease Free Survival(Two year)
研究者
Mohamed s. Zaghloul
Professor
Cairo University