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临床试验/NCT03756207
NCT03756207Unknown不适用

Clinical Study on Efficacy and Safety of Multidisciplinary Bladder-preservation Therapy for Muscle-invasive Bladder Cancer in China

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
80
试验地点
1
主要终点
Disease specific survival (DSS) time

研究概览

简要总结

A multidisciplinary approach has led to the development of bladder-preservation therapy using maximal transurethral resection followed by radiotherapy with concomitant radio-sensitizing chemotherapy for muscle-invasive bladder cancer.

详细描述

Multidisciplinary management improves complex treatment decision making in cancer care, but its impact for bladder cancer has not been documented. Although radical cystectomy (RC) has long been the standard of care for the management of muscle-invasive bladder cancer (MIBC), a multidisciplinary approach has led to the development of bladder-preservation therapy using maximal transurethral resection (TURBt) followed by radiotherapy with concomitant radio-sensitizing chemotherapy for MIBC. There are no randomized-controlled data comparing radical cystectomy with multidisciplinary bladder-preservation therapy (MBPT) available for comparison. However, observational data continues to support the use of MBPT as an acceptable alternative for patients with MIBC who wish to preserve their bladder or are not candidates for cystectomy because it may result in equivalent disease outcomes in select patients and offers the benefit of maintaining a functioning urinary system with subsequent improvements in quality of life. But there are also lots of issues need to be studied, such as the patient selection, approaches for completeness of TURBt, choices of radio-sensitizing chemotherapy, accuracy of radiotherapy and so on. In this study, the investigators plan to prospectively recruit 80 MIBC patients, who don't want to receive RC or are not candidates for RC, treated with MBPT from Nov 2018 to Dec 2020 in Peking University Third Hospital. The investigators will collect, compare and analyze their clinic-pathological data before and after MBPT, in order to confirm the safety and efficacy of MBPT for MIBC in China. At the same time, the investigators want to find out the patients who are not suitable for MBPT and the approach which can improve the efficacy of MBPT, as a result, the investigators intend to make a standard MBPT approach for Chinese MIBC patients.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Bladder urothelial carcinoma
  • Clinical stage: T2-T4, non-metastasis
  • Eastern Cooperative Oncology Group score (ECOG)≤ 1, Karnofsky performance score≥ 70
  • Patients don't want to receive RC or are not candidates for RC
  • Normal bladder function

排除标准

  • History of abdominal and pelvic radiotherapy
  • History of other malignant tumor
  • Pregnant or lactating patients
  • Severe comorbidity: cardiac infarction, arrhythmia, heart failure, et al

研究组 & 干预措施

Multidisciplinary Therapy

Experimental

Multidisciplinary bladder-preservation therapy: Maximal transurethral resection followed by radiotherapy with concomitant radio-sensitizing chemotherapy

干预措施: multidisciplinary bladder-preservation therapy (Procedure)

结局指标

主要结局

Disease specific survival (DSS) time

时间窗: From date of treatment initiation until the date of death due to bladder cancer, assessed up to 60 months.

Events were defined as death attributable to bladder cancer. The time to DSS was the interval between treatment initiation and death due to bladder cancer, or the most recent follow-up if no event occurred.

Overall survival (OS) time

时间窗: From date of treatment initiation until the date of death due to any cause, assessed up to 60 months.

Events were defined as death due to any cause. The time to OS was the interval between treatment initiation and death, or the most recent follow-up if no event occurred.

Complete response rate

时间窗: 6-8 weeks after chemoradiation

Response to MBPT depending on cystoscopy, TURBt, or urinary cytology

次要结局

  • Quality of life score 1(6-8 weeks after chemoradiation)
  • Quality of life score 2(6-8 weeks after chemoradiation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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