DRKS00003394已完成未知
Prospective randomized study to comparing an extended pelvic lymphadenectomy with a limited in the surgical treatment of bladder cancer - LEA - AB 25/02 - LEA - AB 25/02
Klinikum rechts der Isar der TU München0 个研究点目标入组 459 人开始时间: 2012年1月20日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 459
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 100 Years（—）
- 性别
- All
入选标准
- •Histologically, muscle-invasive bladder cancer, locally completely resectable(T2 - T4a, Nx)
- •- Written consent of the patient
- •- Patient compliance and geographic proximity to allow adequate follow-up
排除标准
- •- Histologically or by imaging diagnostics proven organ metastases
- •- Radiographic evidence of enlarged lymph nodes (> 1 cm) above the aortic bifurcation in conjunction with pelvic lymph node metastases
- •- Radiographic or other evidence of T4b-tumor (infiltration of the pelvic wall or other organ systems)
- •- Prior neoadjuvant chemotherapy of bladder cancer
- •- Prior previous pelvic lymphadenectomy
- •- Prior radiotherapy to the pelvis
- •- internal medical or anesthetic risk factors that require a short operation time
- •- Palliative cystectomy (f.e. bulky-disease, infiltration of adjacent structures)
- •- Evidence of another tumor restricting life expectancy of the patient
研究者
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