Research on the Combined-Modality Treatment Model of Bladder Preservation in Muscular Invasive Bladder Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- bladder preservation rate
研究概览
简要总结
This research aims to explore the therapeutic effect of neoadjuvant chemotherapy in muscular invasive bladder cancer of T2-4aN0M0, and the survival effect of combined-modality treatment model，then to clarify the probability of bladder preservation, corresponding cancer specific survival, and the quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •bladder urothelium carcinoma
- •life expectancy≥1 year
- •ECOG PS 0-1
- •have no previously received radiotherapy or chemotherapy
- •have no major organ dysfunction
- •have been provided informed written consent
排除标准
- •extensive carcinoma in situ or ureter invaded
- •distant metastasis at primary diagnosis or lymphatic metastasis according to clinical diagnosis
- •have severe major organ dysfunction
- •cannot finish treatments because of other severe diseases or life expectance≤6 months
- •exist other malignant tumors
- •have severe coagulation disorders
- •no other trails participated in 4 weeks
研究组 & 干预措施
Therapy Arm
Patients who have response to neoadjuvant chemotherapy will be separated into two groups (GI cT0-1 and G2 ≥cT2). G1receive concurrent radiochemotherapy, and G2 receive partial resection of the bladder+lymphadenectomy+adjuvant radiotherapy.Patients who have no response to neoadjuvant chemotherapy or disagree to receive the sequential treatment will receive the radical resection of bladder.
干预措施: Intensity modulated radiation therapy, Radical cystectomy (Procedure)
结局指标
主要结局
bladder preservation rate
时间窗: 3 years
bladder preservation rate
次要结局
未报告次要终点
研究者
Jianzhong Shou
Clinical Professor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences