Observation Versus Immediate Surgery of Low Risk Bladder Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Event-Free Survival
研究概览
简要总结
This trial is a randomized, multi-center, non-inferiority study comparing observation versus immediate surgery for low grade, noninvasive bladder cancer.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of low grade, noninvasive urothelial carcinoma of the bladder with a new recurrence that meets the following criteria:
- •total tumor burden ≤3cm in size (multiple lesions permitted)
- •low grade appearance (grade 1 or grade 2)
- •noninvasive appearance (Ta)
- •no history of carcinoma in situ (CIS) or lesions concerning for CIS
- •negative urine cytology (atypical or suspicious for low grade neoplasm are acceptable)
排除标准
- •High grade and/or invasive and/or carcinoma in situ disease
- •Concomitant upper tract urothelial carcinoma
- •Any patient who is pregnant or who may have plans to become pregnant.
- •Positive cytology
研究组 & 干预措施
Observation
Patients will not undergo immediate surgery. These patients will undergo surveillance cystoscopy and urinary cytology every 3 months for 12 months. Surgery will commence after 12 months of observation or sooner if cystoscopic evidence of disease progression or patient desire.
干预措施: Observation (Other)
Observation
Patients will not undergo immediate surgery. These patients will undergo surveillance cystoscopy and urinary cytology every 3 months for 12 months. Surgery will commence after 12 months of observation or sooner if cystoscopic evidence of disease progression or patient desire.
干预措施: Surveillance Cystoscopy and Urinary Cytology (Procedure)
Immediate Surgery
Patients will undergo immediate surgery. These patients will undergo surveillance cystoscopy and urinary cytology every 3 months for 12 months. Repeated surgery will be offered for additional recurrences.
干预措施: Immediate Surgery (Other)
Immediate Surgery
Patients will undergo immediate surgery. These patients will undergo surveillance cystoscopy and urinary cytology every 3 months for 12 months. Repeated surgery will be offered for additional recurrences.
干预措施: Surveillance Cystoscopy and Urinary Cytology (Procedure)
结局指标
主要结局
Event-Free Survival
时间窗: 12 months
An event is a complication of any kind, including bleeding requiring blood transfusion, bladder perforation, urinary tract infection, readmission to the hospital, and progression of disease.
次要结局
- Patient-reported Costs(At baseline and 3 months, 6 months, 9 months and 12 months.)
- Proportion of patients with disease progression (either stage or grade)(12 months)
- Self-reported patient anxiety measured using the EORTC QLQ-NMIBC24(At baseline and 3 months, 6 months, 9 months and 12 months.)
研究者
Daniel Lee
Instructor
Vanderbilt University Medical Center