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临床试验/NCT07402317
NCT07402317已完成不适用

Outcome of a New Trimodality Bladder Perservation Protocol for Patients With Muscle Invasive Bladder Cancer

Al-Azhar University1 个研究点 分布在 1 个国家目标入组 97 人开始时间: 2018年12月11日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
97
试验地点
1
主要终点
Clinical ,radiological response , diagnostic cystoscopy and turbt biopsy either before and after neo adjuvant chemotherapy. Assessed response either complete, partial or progressive . according to tumor size,site ,stage, biopsy ( complete or incomplete

研究概览

简要总结

The aim of this study is To evaluate the outcomes of patients with muscle invasive bladder cancer managed by trimodal therapy", Neoadjuvant chemotherapy( NAC) followed by Transurethral resection of the bladder tumor then Radiotherapy, for bladder preservation and capability to reach the goal of better quality of life, compared to radical cystectomy with assessment of factors that may predict treatment response, risk of recurrences and (disease- free and over all)survival of such patients...

详细描述

Bladder Cancer (BC) is a worldwide health problem. It is the 7th most commonly diagnosed cancer in male population worldwide, whilst it drops to 11th for both sexes. Approximately 25% of newly diagnosed patients have muscle-invasive disease. Despite potentially curative radical surgery, approximately 50% of muscle invasive cases develop relapse within 2 years, and most of them die. Organ preservation has been the main goal of cancer care in the last two decades, yet it is not generally adopted for the cure of non-metastatic muscle invasive bladder cancer[1].

The standard of care for muscle invasive urothelial-cell carcinoma (UCC) of the bladder is radical cystectomy (RC). Radical surgery results in long-term survival rates of 40%-60% [2-4]. Sophisticated techniques for urinary diversion have been developed to improve patients' quality of life; however, this cannot substitute for the patient's original bladder [5].

Attempts to obtain bladder preservation are only justified when they have a high likelihood of achieving local cure with no compromise in survival rates. Transurethral resection of the bladder tumor (TURBT) alone, chemotherapy alone or radiation therapy alone provide inferior outcomes to radical cystectomy with only 20% to 40% local control rates in muscle invasive urothelial-cell carcinoma (UCC). Several groups have reported the value of combining all three modalities, with salvage cystectomy being reserved for patients with incomplete response or local relapse [6,7]. Bladder preservation approaches became increasingly favored, and became successful , essentially after the emergence of concurrent chemo-radiation protocols with cisplatin. The National Bladder Cancer Group first demonstrated the safety and efficacy of cisplatin, as a radiation sensitizer, in patients with MIBC who were unsuitable for cystectomy[8].

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • clinical case's of muscle invasive bladder cancer .T2 or more bladder cancer according to the American Joint Committee on Cancer (AJCC) staging system.
  • Age >18 years old. .Adequate bone marrow function. .Adequate renal functions. .Adequate hepatic functions.

排除标准

  • .Distant metastases, pelvic lymph node metastasis. .Evidence of tumor-related hydronephrosis. .Severe irritative bladder symptoms.
  • Persistent infection. .Associated serious medical or psychiatric illness. .Prior or concurrent malignancy of any other site unless the patient was disease free for 5 years.
  • .Previous systemic chemotherapy or pelvic irradiation. .Pregnant or lactating female patients. .Each patient will give written informed consent before entering the study.

研究组 & 干预措施

T2 bladder cancer

Experimental

T2 patients

干预措施: Transurethral resection of bladder tumor: We are aimed at Complete TURBT. Which was defined as no residual tumor, whereas incomplete TURBT (Procedure)

结局指标

主要结局

Clinical ,radiological response , diagnostic cystoscopy and turbt biopsy either before and after neo adjuvant chemotherapy. Assessed response either complete, partial or progressive . according to tumor size,site ,stage, biopsy ( complete or incomplete

时间窗: 4 years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mahmoud Esmail Ali Abdelbaki

Assistant lecturer

Al-Azhar University

研究点 (1)

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