NCT01196403Unknown2 期
Bladder Cancer: Open Versus Laparoscopic or Robotic Cystectomy. A Study to Determine the Feasibility of Randomization to Open Versus Minimal Access Cystectomy in Patients With Bladder Cancer.
Wales Cancer Trials Unit8 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2009年1月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 92
- 试验地点
- 8
- 主要终点
- Percentage of patients who consent to be randomized
研究概览
简要总结
RATIONALE: Minimal-access surgery uses a smaller opening in the body to remove the tumor than is used in standard surgery. It is not yet known whether minimal-access surgery to remove the bladder is more effective than standard surgery to remove the bladder in treating patients with bladder cancer.
PURPOSE: This randomized phase II trial is studying standard surgery to see how well it works compared with minimal-access surgery in treating patients with bladder cancer.
详细描述
OBJECTIVES:
Primary
- To determine the feasibility of randomizing patients with bladder cancer to undergo an open cystectomy versus a minimal-access cystectomy (laparoscopic or robotic cystectomy).
Secondary
- To assess the safety and efficacy of laparoscopic or robotic cystectomy and the reasons for non-acceptance of randomization.
- To collect safety and toxicity data, including measures of postoperative morbidity and surgical complications. (Exploratory)
- To investigate anatomical lymph node dissection (an indicator for oncological clearance) and completeness of cancer surgery. (Exploratory)
- To determine the quality of life of these patients using EORTC QLQ-C30 and EORTC QLQ-BLM30 questionnaires. (Exploratory)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •DISEASE CHARACTERISTICS:
- •Histopathologically confirmed bladder cancer, including any of the following cell types:
- •Urothelial cell (transitional cell) carcinoma
- •Squamous cell carcinoma
- •Adenocarcinoma
- •Stage pT1, pT2, or pT3 disease OR mobile bladder mass on bimanual examination under anesthesia
- •No enlarged nodes or distant metastases on CT or MRI scan of the abdomen and pelvis
- •No upper urinary tract disease
- •PATIENT CHARACTERISTICS:
- •American Society of Anesthesiologist (ASA) status 1-3
- •Life expectancy > 24 months
- •Not pregnant or nursing
- •Negative pregnancy test
- •No concurrent disease that would render the patient unsuitable for the trial
- •No presence of urosepsis
- •PRIOR CONCURRENT THERAPY:
- •May have received prior neoadjuvant chemotherapy provided study surgery is performed between 3 and 10 weeks from the date of the completion of chemotherapy treatment
排除标准
- 未提供
结局指标
主要结局
Percentage of patients who consent to be randomized
次要结局
- Potential barriers to randomization via semistructured qualitative interviews with patients who consent to registration and do not accept randomization
- Potential factors relating to non-registration of patients who are eligible for inclusion but have not been registered based on review of anonymous screening logs
- Safety and efficacy
- Quality of life data measuring return to normal activities (physical, social, and occupational)
研究者
研究点 (8)
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