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临床试验/NCT03274284
NCT03274284Unknown4 期

Chemoradiotherapy for Recurrent T1G3 Bladder Cancer After BCG Failure

Assiut University0 个研究点目标入组 20 人开始时间: 2017年10月最近更新:
适应症
干预措施

试验速览

阶段
4 期
入组人数
20
主要终点
Result of chemoradiation for recurrentT1G3 BC after BCG failure

研究概览

简要总结

To evaluate the short term results of chemoradiation in case of T1G3 BC after BCG failure.

详细描述

Non- muscle invasive bladder cancer (NMIBC) is a heterogeneous group of cancers. For most urologists the treatment of T1G3 tumor poses a dilemma of management.The spectrum of clinical behavior includes; T1 lesions that will not progress however T1G3 may be potentially lethal, associated with metastatic disease at the time of presentation.

The major goal of treatment for T1G3 BC should be bladder preservation whenever possible.

Intravesical therapy with Bacille Calmette Guerin (BCG) may decrease the recurrence rate by compared with transurethral resection of bladder tumor (TURBT) alone.

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
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients with recurrent T1G3 bladder cancer after 6 doses of BCG consenting for chemoradiation and refusing radical cystectomy

排除标准

  • Any patients with distant metastasis or positive LN on CT or MRI.
  • Patients unfit for chemoradiation

研究组 & 干预措施

chemoradiotherapy

Experimental

Chemoradiation in the form of cisplatin plus conformal radiotherapy 55GY/20 fractions which is biologically effective to 64GY/32 fractions fr

干预措施: chemoradiation (Combination Product)

结局指标

主要结局

Result of chemoradiation for recurrentT1G3 BC after BCG failure

时间窗: followup within two years

treatment of 20 patients with recurrent T1G3 BC by chemoradiation to see efficacy and safety .and to reduce the number of recurrent cases and improve survival.

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

MokhtarDawood

Assistant Lecturer of Urology

Assiut University

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